AU2013209081A1

AU2013209081A1 - Kit for producing a vaccine

Info

Publication number: AU2013209081A1
Application number: AU2013209081A
Authority: AU
Inventors: Gerald BEHRENS; Knut Elbers; Dirk Neven RAULEDER
Original assignee: Boehringer Ingelheim Vetmedica GmbH; Boehringer Ingelheim Vetmedica Inc
Current assignee: Boehringer Ingelheim Vetmedica GmbH
Priority date: 2012-01-13
Filing date: 2013-01-14
Publication date: 2014-08-14
Anticipated expiration: 2033-01-14
Also published as: CN104039347A; BR112014017031B1; KR20140112508A; DE202013007396U1; AU2013209081B2; CL2014001798A1; WO2013104550A1; BR112014017031A8; JP2015508312A; PL2802348T3; EP2802348B1; EP2802348A1; CA2860631C; SG11201403957WA; EA201400812A1; BR112014017031A2; CA2860631A1; EA033354B1

Abstract

The invention relates to a kit, to a use, and to a method for producing a vaccine for immunizing against porcine circovirus disease and/or enzootic pneumonia of pigs, wherein a first container is filled only partially with a first vaccine and a second container is filled with a second component, wherein the second vaccine is transferred into the first container by means of an adapter device by penetrating a closing device for the first time and/or one time only and the vaccine is produced in the first container, which enables a simple, less error-prone and more hygienic operation with reduced material use.

Description

- 1 Kit for the preparation of a vaccinating agent The present invention relates to a kit for the preparation of a vaccinating agent, a use of the kit for preparing a vaccinating agent, a use of at least two starting materials for prepar 5 ing a vaccinating agent and a process for providing a vaccinating agent The present invention relates in particular to the manufacture and provision of vaccinat ing agents, particularly in the veterinary medical field. Primarily, the present invention re lates to vaccinating agents for immunising pigs against Porcine Circovirus, particularly 10 type 2, also known as Porcine Circovirus Disease or PCVD, and/or against bacteria of the strain Mycoplasma hyopneumoniae, also known as Enzootic Pneumonia or EP. It is known that the above-mentioned diseases can be prevented by immunisation with vaccines. Vaccinating agents are usually provided for injection and have to be correspond 15 ingly sterile. Moreover, each individual injection causes stress to the creature being treat ed and for this reason the number of vaccination processes should be kept to a minimum. One known possibility for reducing the number of vaccination processes are so-called combined vaccinations by which immunisation against different diseases can be provided 20 in just a few or even just one session. However, a combined vaccination is often not possi ble as a result of incompatibilities of different vaccines or components thereof with one another. Even if an at least short-time compatibility can be achieved, these combination vaccines have to be produced on site. In the veterinary medical field, in particular, the vac cines then have to be prepared and/or administered outdoors. A problem here is that the 25 combination vaccine may become contaminated, for example with pathogens, particularly if a mixing vessel has to be punctured several times. Object of the present invention is to provide a kit for preparing a vaccinating agent, a use of this kit for preparing a vaccinating agent, a use of two starting materials for preparing a 30 vaccinating agent and a process for providing a vaccinating agent by which a vaccinating agent can be produced, even from starting materials which are only briefly stable with one another, by the simplest possible method, which is not prone to errors and is at the same time hygienic. 35 The above problem is solved by a kit for preparing a vaccinating agent according to claim 1, by a use of such a kit for preparing a vaccinating agent according to claim 55, by a use of at least two starting materials for preparing a vaccinating agent according to claim 56 or -2 by a process for providing a vaccinating agent according to claim 116. Advantageous em bodiments are the subject of the sub-claims. In a first aspect the present invention relates to a kit for preparing a vaccinating agent, 5 particularly for preparing a vaccinating agent for use in immunising against the disease Porcine Circovirus Disease "PCVD" and/or Enzootic Pneumonia "EP" or against infections with Porcine Circovirus, particularly type 2, and/or Mycoplasma hyopneumoniae. The kit according to the invention comprises a first starting material and a second starting 10 material that is different from the first A starting material for the purposes of the present invention is preferably any source material, particularly a vaccine, a source material com prising a vaccine and/or a component or source material for a vaccinating agent, prefera bly an antigen or a composition containing an antigen. 15 Moreover, the kit comprises a first container that is only partly filled with the first starting material and a second container holding the second starting material. A container for the purposes of the present invention is preferably a structure enclosing a volume, preferably configured to receive a liquid, particularly a vessel, a bottle, a bag or 20 the like. The kit further comprises an adapter device for establishing a fluid connection, wherein the fluid connection can be established between the first and second containers. It is also preferable that the adapter device should be configured to establish a fluid connection be 25 tween the interiors of the first container and the second container. Moreover in the proposed kit at least one of the containers is closed off by a closure device on the operating side. Preferably, both containers are closed off by a closure device on the operating side. Preferably, an airtight and/or sterile closure is provided. In particular this 30 may be a seal, a rubber stopper or the like, wherein the closure device can preferably be penetrated and/or pierced, particularly reversibly. In this way the containers, i.e. at least one of the containers, can be sealed in sterile manner. It is envisaged that the second container can be connected to the first container by means 35 of the adapter device, when the closure device is pierced for the first and/or only time, -3 such that the second starting material enters the first container, particularly is transported therein, and there forms the vaccinating agent with the first starting material. The closure device or closure devices are thus preferably embodied to be penetrated or pierced by means of the adapter device. The adapter device is preferably configured to be able to 5 penetrate and/or pierce the closure device or closure devices. In this way a fluid connec tion can be provided between the first and second containers. With the kit according to the invention it is thus possible to prepare a vaccinating agent from two starting materials with only two containers and an adapter device, particularly 10 for use in immunising against the diseases caused by infections with Porcine Circovirus and/or Mycoplasma hyopneumoniae, preferably for use in immunising against the diseas es caused by infections with Porcine Circovirus and Mycoplasma hyopneumoniae. The kit also avoids the use of other incompatible starting materials, particularly by presenting the starting materials and containers in kit form. 15 Advantageously, the vaccinating agent may be formed in the only partly filled first con tainer, avoiding the need for additional containers and/or additional adapter devices. This makes the application as simple as possible. In addition, the use of materials is minimised as the number of components required is reduced to a minimum. 20 Also it is particularly advantageous that simply penetrating or piercing the closure device, for the first or only time, is enough to produce the vaccinating agent In fact, this avoids foreign substances or pathogens getting into the vaccinating agent during multiple pene tration or piercing of the closure device. 25 In the present invention, for reasons of clarity, a distinction is made between vaccines as possible constituents of one or more starting materials and the vaccinating agent as the product prepared from the starting materials. 30 Thus, the term "vaccinating agent", even when it also denotes a vaccine, preferably de notes the end product that is preferably produced or prepared from the two starting ma terials and/or is used for the treatment Particularly preferably, the vaccinating agent is a combination vaccine, preferably containing at least two vaccines different from one anoth er or at least two antigens different from one another or two compositions containing an 35 tigen, where the compositions containing the antigen differ at least in the antigens pre sent The term "vaccines", even when it refers to vaccinating agents, preferably refers to starting materials or constituents thereof, particularly antigens or antigen-containing compositions. By an "antigen" or an "antigen-containing composition" is preferably meant -4 a substance or a composition containing the substance which can elicit an immune re sponse in an animal after administration or can intensify an existing immune response. The differentiation between the terms "vaccinating agent" and "vaccine" thus serves main ly only to clarify or to distinguish the product from possible components of one or more of 5 the starting materials. Consequently it is possible to replace the term "vaccinating agent" by the term "vaccine" or vice versa. A kit, under the terms of the present invention, is in particular a combination and/or sys tem comprising the first container, the second container and preferably the adapter de 10 vice, which form components of the kit The components of the kit are preferably sold as a set, particularly in a combined package or the like. However, it is also possible for the components specified to form a loose combination for joint use. A common or linking component may be provided, for example a common instruction manual, recommenda tions for use, references in the captions on one or more of the components of the kit or the 15 like. Another aspect of the present invention that can also be implemented independently re lates to the use of a preferably proposed kit for the preparation and/or provision of a vac cinating agent, particularly for immunising against the disease(s) Porcine Circovirus Dis 20 ease "PCVD" and/or Enzootic Pneumonia "EP" or infections with Porcine Circovirus and/or infection with bacteria of the Mycoplasma strain, particularly Mycoplasma hy opneumoniae, preferably for immunisation against the diseases Porcine Circovirus Dis ease "PCVD" and/or Enzootic Pneumonia "EP" or against infections with Porcine Circovirus, particularly Porcine Circovirus type 2 and infection with bacteria of the Myco 25 plasma strain, particularly Mycoplasma hyopneumoniae. Another aspect of the present invention that can also be implemented independently re lates to the use of at least two starting materials for preparing a vaccinating agent, particu larly for simultaneous immunisation, in particular, against the disease(s) Porcine 30 Circovirus Disease "PCVD" and/or Enzootic Pneumonia "EP", preferably for in particular simultaneous immunisation against the diseases Porcine Circovirus Disease "PCVD" and Enzootic Pneumonia "EP", or against infections with Porcine Circovirus, particularly Por cine Circovirus Type 2 and infection with bacteria of the Mycoplasma strain, particularly Mycoplasma hyopneumoniae, wherein the vaccinating agent is prepared using starting 35 materials in containers and an adapter device. A kit may be used as proposed. It is also envisaged that a first starting material is used in a first container only partly filled with the first starting material and a second starting material that is different from the first is used in a second container holding the second starting material and an adapter de- -5 vice is used which is configured so as to establish a fluid connection between the first and second containers. At least one of the containers is closed off by a closure device on its op erating side. A fluid connection between the first and second containers is produced by means of the adapter device when the closure device is penetrated for the first and/or on 5 ly time, in order to transfer the second starting material through the adapter device and closure device into the first container and produce the vaccinating agent in the first con tainer. Another aspect of the present invention that can also be implemented independently re 10 lates to a process for preparing a vaccinating agent from a first starting material and a sec ond starting material different from the first, particularly for especially simultaneous im munisation against the disease Porcine Circovirus Disease "PCVD" and/or Enzootic Pneu monia "EP", preferably for particularly simultaneous immunisation against the diseases Porcine Circovirus Disease "PCVD" and Enzootic Pneumonia "EP". The vaccinating agent 15 may be prepared using a kit as proposed. Between a first container only partly filled with the first starting material and a second container holding the second starting material a fluid connection is established by an adapter device, such that the fluid connection between the first and second containers is 20 established by means of the adapter device when at least one closure device, which pref erably closes off at least one of the containers and is provided on the operating side, is penetrated or pierced for the first and/or only time by the adapter device. The second starting material is transferred or conveyed through the adapter device and the closure device into the first container. In the first container, the vaccinating agent is formed from 25 the first starting material and the second starting material. Preferably, the first and/or second starting material is or comprises a vaccine, an antigen and/or an antigen-containing composition. Moreover, the first starting material may differ from the second starting material. The first starting material may thus be or comprise a 30 first vaccine, a first antigen and/or a composition containing a first antigen and the second starting material may be or comprise a second vaccine, different from the first, a second antigen different from the first and/or an antigen-containing composition, the antigen of which differs from that of the first antigen-containing composition. Preferably, the first vaccine and the second vaccine, or the first antigen and the second antigen, or the compo 35 sitions containing the various antigens are for particularly simultaneous immunisation against various diseases or pathogens such as for example against the disease Porcine Circovirus Disease "PCVD" and Enzootic Pneumonia "EP", or for immunisation against Porcine Circovirus, preferably Porcine Circovirus type 2 and against Mycoplasmas, prefer ably against Mycoplasma hyopneumoniae. This makes it possible to produce a combina 40 tion vaccine. The starting materials may contain other substances apart from vaccines, particularly water, adjuvants and/or excipients.

-6 It is particularly preferable that the first starting material comprises only a first of the components Mycoplasma vaccine or Mycoplasma antigen, respectively, and Circovirus vaccine or Circovirus antigen, respectively, (and optionally other substances). The first 5 starting material may thus comprise either Mycoplasma vaccine, or one or more Myco plasma antigens or alternatively Circovirus vaccine or one or more Circovirus antigens. The first starting material is preferably stored separately from the second starting materi al, particularly if the starting materials are not stable together in the long term. The second starting material preferably only comprises the other of the components Mycoplasma vac 10 cine or one or more Mycoplasma antigens and Circovirus vaccine or one or more Circovirus antigens (and optionally other substances). Thus, if the first starting material contains Mycoplasma vaccine or one or more Mycoplasma antigens, the second starting material contains Circovirus vaccine or one or more Circovirus antigens or vice versa. 15 The Mycoplasma vaccine may comprise attenuated and/or inactivated bacteria, fragments of bacteria or recombinantly produced parts of Mycoplasma hyopneumoniae, but at least one or more Mycoplasma hyopneumoniae antigens. Preferably, the Mycoplasma hy opneumoniae antigen originates from the Mycoplasma hyopneumoniae strain J or the in activated Mycoplasma hyopneumoniae bacteria are those of the strain J. Moreover, the 20 Mycoplasma vaccine may be one of the following vaccines or the Mycoplasma hyopneu moniae antigen may be the antigen or antigens contained in one of the following vaccines: Ingelvac@MycoFlex (Boehringer Ingelheim Vetmedica Inc, St Joseph, MO, USA), Porcilis M. hyo, Myco Silencer@ BPM, Myco Silencer@ BPME, Myco Silencer@ ME, Myco Silencer@ M, Myco Silencer@ Once, Myco Silencer@ MEH (all from Intervet Inc., Millsboro, USA), Stel 25 lamune Mycoplasma (Pfizer Inc., New York, NY, USA), Suvaxyn Mycoplasma, Suvaxyn M. hyo, Suvaxyn MH-One (all previously from Fort Dodge Animal Health, Overland Park, KS, USA (now Pfizer Animal Health). The Circovirus vaccine may comprise attenuated and/or inactivated porcine Circovirus, 30 preferably type 2, particularly type 2 ORF2 protein. It is particularly preferable to use re combinantly expressed ORF2 protein of Porcine Circovirus type 2, preferably expressed in and obtained from in vitro cell culture. Examples of ORF2 proteins of Porcine Circovirus type 2 are described inter alia in International Patent Application W02006-072065. These have proved particularly advantageous for effective vaccination. Moreover, the Circovirus 35 vaccine may be one of the following vaccines, or the Circovirus antigen may be the antigen or antigens contained in one of the following vaccines: Ingelvac@CircoFLEX, (Boehringer Ingelheim Vetmedica Inc, St Joseph, MO, USA), CircoVac@ (Merial SAS, Lyon, France), CircoVent (Intervet Inc., Millsboro, DE, USA), or Suvaxyn PCV-2 One Dose@ (Fort Dodge Animal Health, Kansas City, KA, USA). 40 -7 The Circovirus vaccine, if it contains the ORF2 protein, preferably contains between 2 ig and 150 ig, preferably between 2 ig and 60 g, more preferably between 2 ig and 50 g, more preferably between 2 g and 40 rig, more preferably between 2 ig and 30 tg, more preferably between 2 g and 25 ig, more preferably between 2 g and 20 ig, more prefer 5 ably between 4 ig and 20 rig, more preferably between 4 ig and 16 ig ORF2 protein per dose to be administered. The Circovirus vaccine is preferably produced or designed so that 1 ml of the vaccine corresponds to a dose of 1 and/or one (single) dose. In particular the Circovirus vaccine may contain ORF2 protein in amounts of more than 2 g/ml, preferably more than 4 g/ml and/or less than 150 g/ml, preferably less than 60 g/ml, 50 g/ml, 10 40 ig/ml, 30 ig/ml or 25 ig/ml, particularly less than 20 ig/ml. This helps to ensure reli able administration. The Mycoplasma vaccine, if it contains inactivated Mycoplasma bacteria, preferably inacti vated Mycoplasma hyopneumoniae bacteria, preferably contains between 103 and 109 col 15 ony forming units (CFU), preferably between 104 and 108 (CFU), more preferably between 10s and 106 (CFU) per dose to be administered, the corresponding CFU being selected be fore the inactivation of the bacteria. The Mycoplasma vaccine is preferably prepared or designed such that 1 ml of the vaccine corresponds to a dose of 1 and/or one (single) dose. In particular, the mycoplasma vaccine may contain more than 103 CFU/ml, preferably 20 more than 104 CFU/ml, particularly more than 105 CFU/ml and/or less than 109 CFU/ml, preferably less than 108 CFU/ml, particularly less than 107 CFU/ml or 106 CFU/ml inacti vated Mycoplasma bacteria, preferably inactivated Mycoplasma hyoneumoniae bacteria, particularly before the inactivation of the bacteria. 25 At least one of the starting materials and/or the vaccinating agent may contain an adju vant, preferably a polymeric adjuvant, particularly carbomer. Preferably, at least or exactly one of the two starting materials, preferably both starting materials, contain a quantity of adjuvant of 500 lg to 5 mg, preferably 750 lg to 2.5 mg, more preferably about 1 mg of ad juvant per dose to be administered. The starting materials are preferably prepared or de 30 signed such that 1 ml of the respective starting material corresponds to a dose of 1 and/or one (single) dose. The use of an adjuvant, preferably a polymeric adjuvant, such as car bomer, for example, has proved advantageous in terms of the efficiency of the immunisa tion or its duration of effect The use of alternative and/or additional adjuvants is not ex cluded, however. 35 It has also proved advantageous if the total volume of the first container exceeds the vol ume of the first starting material at least by the volume of the second starting material, particularly by more than 2%, preferably more than 5%, particularly more than 8%. This ensures that the first container has sufficient capacity for the second starting material. In 40 addition, the volume of the first container, which exceeds the sum of the volumes of the first and second starting material, ensures effective mixing of the starting material, partic- -8 ularly when the first container is moved after the transfer of the second starting material into the first container. It is thus preferable on the one hand that the total volume of the first container should ex 5 ceed the sum of the volumes of the starting materials. On the other hand, the first contain er is moved during and/or after the transfer of the second starting material into the first container, to achieve or speed up homogeneous mixing and/or reaction. According to another aspect of the present invention, the first container may be used for 10 installation in or use with an injection device. In particular, this is an injection device for multiple use, such as for example an injection gun, a pressure injection and/or a self-filling syringe as used for example for vaccinating larger herds of animals. In this way, the num ber of penetrations of the closure device of the first container can be minimised. In partic ular, the number of penetrations can be reduced to two, namely one penetration for the 15 preparation process and a second penetration for drawing up the vaccinating agent Par ticularly advantageously, the adapter device may be used for connection to the injection device, thus reducing the number of penetrations to one. The kit according to the invention may comprise an injection device or be associated with 20 one such. In particular, an opening, a flange or other connecting or closure element of the first container and/or the adapter device may be configured so as to allow direct use in or with an injection device. Moreover, the opening, the flange or the other connecting and/or closure element may be specifically designed for connection to a particular injection de vice. Once again this decreases the likelihood of incorrect use, particularly of incorrect 25 amounts of active substance or methods of administration. One or more of the containers may contain, in addition to the respective starting material, a gas, particularly a protective gas, thus making it possible to improve the long-term sta bility of the respective starting material. Moreover, the adapter device may be embodied 30 to transfer the gas from the first container into the second container when the second starting material is transferred from the second container into the first container, particu larly with the exclusion of the surrounding atmosphere. Thus ensures that effects on one or more of the starting materials and/or the vaccinating agent as a result of oxidation or the like, in particular, is ruled out and/or a pressure equalisation is made possible. 35 Further aspects, details, features, properties and advantages of the present invention will become apparent from the claims and the graphic representation as well as the following -9 description of a preferred embodiment of the proposed kit for preparing a vaccinating agent In the drawings: Fig. 1 shows a first container, partly filled with a first starting material; 5 Fig. 2 a second container with a second starting material; Fig. 3 an adapter device for fluidically connecting the containers; 10 Fig. 4 a second container with adapter device inserted; Fig. 5 a first and a second container connected by an adapter device; Fig. 6 a first container with vaccinating agent; 15 Fig. 7 an injection device with first container attached. In the Figures, the same reference numerals are used for identical or similar parts, where corresponding or comparable properties and advantages are obtained even if the descrip 20 tion is not repeated. Fig. 1 shows a first container 1 with a wall 2 delimiting a volume. The container 1 com prises an opening region 3 which may have a flange 4, for example an annular shoulder. Preferably, the container 1 is closed off by a closure device 5, particularly in sterile and/or 25 airtight manner. For this purpose it may be envisaged that the closure device 5 abuts firm ly on the flange 4, more particularly is pressed against it. For example, a clamping element 6, particularly a clamping ring, may be provided which presses the closure device 5 against the flange 4. The clamping element 6 may be metallic 30 and may contain aluminium or stainless steel, in particular. Alternatively or additionally, it is possible for the clamping element 6 to include plastics or be made of plastics. The - 10 clamping element 6 is preferably embodied so as to pressure the closure device 5 against the flange 4 and thereby enable the first container 1 to be sealed off, particularly from the environment and/or atmosphere. 5 In the embodiment shown, the closure device 5 closes off or seals the first container 1. The closure device 5 is preferably penetrable or pierceable for example with a spike, a needle, a hollow needle, a double spike or the like. Particularly preferably, the closure device 5 is configured to be penetrable or pierceable in such a way as to achieve a reversible closure, i.e. even after penetration or piercing and removal of the corresponding agent, the closure 10 device 5 particularly makes it possible to obtain an in particular airtight and/or sterile seal. The closure device 5 may contain rubber, particularly halobutyl type 1 rubber and/or may be in the form of a rubber stopper. However, the closure device 5 may also consist of or contain other materials, particularly materials that are also used for the wall 2. 15 The wall 2 of the first container 1 preferably comprises a sterilisable material, preferably glass, polyethylene, high density polyethylene (HDPE), ethylenevinylacetate (EVA), halo butyl type 1 rubber and/or siliconised chlorobutyl. The wall 2 may be of rigid or flexible construction. The first container 1 may be embodied in particular as a bottle, bag, can or the like. In particular, the first container 1 may be a cartridge, an insert or an installation 20 or attachment device for an injection device 22 (cf. Figure 7), as will be discussed in more detail hereinafter. In the embodiment shown in Figure 1 the container 1 is only partly filled with a first start ing material 7. The container 1 is for example filled with the first starting material to an 25 amount of less than 70 %, preferably less than 50 %, particularly less than 45 % and/or more than 10 %, preferably more than 20 %, particularly more than 30 %. Besides the first starting material the first container 1 may contain a gas 8, particularly a protective gas, noble gas, inert gas or the like. In this way the shelf life of the first starting 30 material 7 can be improved. Preferably, the sum of the volumes of the first starting material 7 and the gas 8 gives the total volume of the first container 1, preferably therefore the volume enclosed by the wall 2 of the first container 1, particularly with the closure device 5, or a smaller volume. 35 Figure 2 shows a second container 9 with a second starting material 10. The second con tainer 9 may comprise a wall 11, an opening region 12, a flange 13, a closure device 14 - 11 and/or a clamping element 15, which may preferably have the same or similar properties to the corresponding elements of the first container 1, and for this reason the description will not be repeated at this point. Therefore, only possible differences between the second container 9 and the first container 1 will be mentioned hereinafter. 5 The second container 11 is preferably configured with an at least partially flexible wall 11, wherein in particular pressure can be exerted on the second starting material 10 by press ing on the wall 11. This can help to promote the expulsion or transfer of the second start ing material 10. 10 Preferably, the volume of the gas 8 corresponds to or exceeds the volume of the second starting material 10. In particular, the volume of the gas 8 in the first container 1 exceeds the volume of the second starting material 10 by more than 2 %, preferably more than 5 %, particularly more than 8 % and/or less than 80 %, preferably less than 50 %, particu 15 larly less than 40 % or 30 %. This allows the first container 1 to take up minimal space while at the same time preparing the vaccinating agent 21 (cf. Figure 5) in the first con tainer 1. In particular, a sufficient volume of gas 8 remains in the first container 1, thus al lowing homogeneous mixing by movement of the first container 1. 20 In the embodiment shown in Figure 2 the second container 9 is at least substantially filled with the second starting material 10. Alternatively or additionally, however, it is also pos sible for the second container 9 to be completely filled with the second starting material 10 or only partly filled with the second starting material 10. If the second container 9 is only partly filled with the second starting material 10, a gas 16, particularly a protective 25 gas, may be provided which preferably fills the volume of the second container 9 enclosed by the wall 11, particularly with the closure device 14, together with the second starting material 10. It is particularly preferred if the total volume of the first container 1 exceeds the volume of 30 the first starting material 7 at least by the volume of the second starting material 10. The volume of the first container 1 thus preferably exceeds the total of the volumes of the first starting material 7 and second starting material 10. Figure 3 shows an adapter device 17 for providing a fluidic connection between the first 35 container 1 and the second container 9. The adapter device 17 may comprise at least one, preferably two, but also more than two adapter elements 18, particularly needles, hollow needles, spikes, wedges or the like.

- 12 The adapter device 17 preferably comprises a fluid channel 19, particularly for fluidically connecting the interiors of the containers 1 and 9. The adapter device 17 is in the form of a double spike or hollow needle in the embodiment shown. 5 The adapter device 17 may be configured so that during the transfer of the second starting material 10 into the first container 1 the gas 8 or protective gas passes, or more particular ly is transported, from the first container 1 into the second container 9. For this purpose the adapter device 17 may comprise a venting and/or exhaust device 20. The venting 10 and/or exhaust device 20 is preferably in the form of a channel, particularly at least sub stantially parallel to the fluid channel 19. However, other solutions are also possible. Preferably, the adapter device 17 comprises a channel as the venting and/or exhaust de vice 20, the openings of which are arranged so that when the second starting material 10 15 flows out of the second container 9 under the influence of gravity this allows a backflow of the gas 8 from the first container 1 into the second container 9. In particular the opening of the venting and/or exhaust device 20 facing the first container 1 may be recessed rela tive to the opening of the fluid channel 19 facing the first container 1 in the direction of the longitudinal extent of the adapter device 17 or may be arranged on the side of the opening 20 of the fluid channel 19 remote from the open end of the adapter device 17. The opening of the venting and/or exhaust device 20 facing the second container 9, by contrast, is prefer ably arranged closer to the open end of the adapter device 17 in relation to the opening of the fluid channel 19 facing the second container 9. 25 The adapter device 17 in the embodiment shown in Figure 3 is formed in one piece. How ever it is also possible, alternatively or additionally, for a hose, a tube, or some other flexi ble or rigid transition to be provided between the adapter elements 18. Preferably, the flu id channel 19 and/or the venting and/or exhaust device 20 connect(s) the adapter ele ments 18 with no interruptions. In particular it is possible for a hose, tube or the like to be 30 provided, particularly moulded on, between the adapter elements 18. This permits flexible handling and/or extension of the adapter device 17. The adapter device 17, particularly one or more of the adapter elements 18, may be con figured specifically for the first container 1 and/or for the second container 9. This can be 35 achieved in particular by mechanically configuring at least one of the adapter elements 18 specifically for one of the containers 1, 9, particularly for one of the containers 1, 9 which is associated with the respective adapter element 18, for example by means of a specific thread 3, 12, a specific projection, undercut, a specific lug or other structure. In this way substances other than the first starting material 7 and/or the second starting material 10 - 13 can be prevented from getting into the first container 1 and/or the second container 9. It is also preferable that the opening region of at least one or both containers 1, 9 is specifically configured for the adapter device 17, particularly for an adapter element 18. 5 It is also preferable for a connection to be provided only between the containers 1, 9, pref erably with exclusion of the surrounding atmosphere. For the purposes of the present in vention the atmosphere is preferably already deemed to be excluded even when there is still a slight residual volume of atmospheric origin remaining in the adapter device 17, for example less than 10 ml or 5 ml. 10 The first starting material 7 and/or the second starting material 10 preferably comprise a vaccine. It is also preferable that the starting materials 7, 10 should be different, and in particular should contain different vaccines. 15 As shown in Figures 4 and 5, the adapter device 17 can be used to provide a fluid connec tion between the first container 1 and the second container 9, wherein the second starting material 10 can preferably be transported into the first container 1 with the assistance of gravity and/or by the exerting of pressure on the second starting material 10 through the wall 11 of the second container 9, in order to form the vaccinating agent 21 with the first 20 starting material 7. The vaccinating agent 21 is preferably intended for preventing pigs becoming ill with infections of Mycoplasma hyopneumoniae and/or Porcine Circovirus, particularly type 2, preferably to prevent pigs becoming ill with infections of Mycoplasma hyopneumoniae and Porcine Circovirus type 2, i.e. in the embodiment shown it is a combi nation vaccine. 25 The first container 1, the second container 9 and, preferably, the adapter device 17 prefer ably form a kit or set, and thus preferably have at least one linking common feature for the purposes of the present invention. This common feature may be that the first container 1, the second container 9 and/or the adapter device 17 are packaged together. Alternatively 30 or additionally it is possible that the first container 1, the second container 9 and/or the adapter device 17 have the same operating instructions, the same in-pack leaflet, the same manufacturer's recommendations or the like. It is also possible for captions, label mark ings, symbols or other information on the containers 1, 9 to cross-reference one another or the like. 35 The kit may optionally also comprise other components. Examples of these are one or more injection devices 22, adapter devices for connecting the first container 1 to an injec tion device 22, some other device or another container.

-14 The kit is preferably intended for preparing a vaccinating agent 21 for preventing diseases caused by infections with Porcine Circovirus type 2 and/or Mycoplasma hyopneumoniae, preferably for preventing diseases caused by infections with Porcine Circovirus type 2 5 and/or Mycoplasma hyopneumoniae in pigs. However, different applications are not ex cluded. In particular, it may alternatively be envisaged to use substances other than the vaccines specified or substances or substance mixtures other than starting materials 7, 10, and/or to obtain advantages in respect of ease of handling and the reduced likelihood of an ingress of foreign substances, pathogens or the like. In particular, the alternative start 10 ing materials may be one or more antigens of the following pathogens: Actinobacillus pleuropneumonia (Al); Adenovirus (A2); Alphavirus such as for example Eastern Equine Encephalomyelitis Virus (A3); Bordetella bronchiseptica (A4); Brachyspira spp. (A5), preferably B. hyodysenteriae (A6); B. piosicoli (A7), Brucella suis, preferably the biovars 1, 2, and 3 (A8); Classical Swine Fever Virus (A9); Clostridium spp. (A10), preferably Cl. dif 15 ficile (Al1), Cl. perfringens of types A, B, and C (A12), Cl. novyi (A13), Cl. septicum (A14), Cl. tetani (A15); Coronavirus (A16), preferably Porcine Respiratory Corona Virus (A17); Eperythrozoonosis suis (A18); Erysipelothrix rhusiopathiae (A19) Escherichia coli (A20); Haemophilus parasuis, preferably of subtypes 1, 7 and 14 (A21) Hemagglutinating En cephalomyelitis Virus (A22); Japanese Encephalitis Virus (A23); Lawsonia intracellularis 20 (A24); Leptospira spp. (A25), preferably Leptospira australis (A26), Leptospira canicola (A27), Leptospira grippotyphosa (A28), Leptospira icterohaemorrhagicae (A29), Lepto spira interrogans (A30), Leptospira pomona (A31), Leptospira hardjo (A32) and Leptospi ra tarassovi (A3 3); Mycobacterium spp. (A34) preferably M. avium (A35) and M. intracel lulare (A36); Pasteurella multocida (A37); Porcine Cytomegalovirus (A38); Porcine Parvo 25 virus (A39); Porcine Reproductive and Respiratory Syndrome (PRRS) Virus (A40); Pseu dorabies Virus (A41); Rotavirus (A42); Salmonella spp. (A43), preferably S. thyphimurium (A44) and S. choleraesuis (A45); Staphylococcus spp. (A46) preferably Staph. hicus (A47); Streptococcus spp. (A48), preferably Strep. suis (A49); Swine Herpes Virus (A50); Swine Influenza Virus (A5 1); Swine Pox Virus (A52); Vesicular Stomatitis Virus (A53); Vesicular 30 exanthema of swine virus (A54); and Mycoplasma hyosynoviae (A55). Preferably the starting materials 7 and 10 are different antigens of the pathogens listed here, so that after the mixing of the different starting materials the vaccinating agent 21 can be used for pre venting diseases caused by at least two of the pathogens listed here. 35 To prepare the vaccinating agent 21 the adapter device 17 with an adapter element 18 may be pushed through the closure device 14 of the second container 9 into the interior thereof, particularly as shown in Figure 4. The closure device 14 is thus preferably pene trated by the adapter device 17, particularly an adapter element 18 thereof. 40 Moreover, in particular, as shown in Figure 5, the combination of the second container 9 and adapter device 17, particularly with another adapter element 18 of the adapter device - 15 17, may be pushed through the closure device 5 of the first container 1 into the interior thereof Preferably, the adapter device 17 or the adapter element 18 penetrates the clo sure device 5 of the first container 1. In this way it is possible for the adapter device 17 to provide a fluid connection 20 between the interiors of the first container 1 and the second 5 container 9. In Figures 4 and 5, details of the opening regions 3, 12 of the containers 1, 9 and the adapter device 17 are not shown, for reasons of clarity. Reference is made to Figures 1 to 3 on this subject 10 As shown in Figure 5, the second starting material 10 may be transferred through the adapter device 17 into the first container 1, preferably using gravity and/or by compres sion of the preferably flexibly formed second container 9. Alternative and/or additional methods or procedures for transferring the second starting material 10 into the first con 15 tainer 1 are also possible. In another example, not shown, first the adapter device 17 is used to penetrate the closure device 5 of the first container 1. In a second step the second container 9 is then fitted onto the adapter device 17 already inserted into the first container 1 or is otherwise connected 20 to the adapter device 17 such that a fluidic connection 20 is formed between the first con tainer 1 and the second container 9. In each case it is preferable, after inserting the adapt er device 17 into a first of the containers 1, 9, that the one of the containers 1, 9 that is not yet attached to the adapter device 17 is fitted onto the vertically positioned combination of adapter device 17 and the other one of the containers 1, 9. This prevents one of the start 25 ing materials 7, 10 from flowing out. In one aspect the present invention relates to the penetration, for the first and/or only time, of at least one of the closure devices 5, 14 by the adapter device 17. Particularly pref erably, both containers 1, 9 comprise closure devices 5, 14, which are each penetrated, 30 pierced or perforated for the first and/or only time. This is made possible, in the embodi ment shown, by the fact that the first container 1 is only partly filled with the first starting material 7. Advantageously this makes it possible to produce the vaccinating agent 21, particularly the combination vaccine, without having to use a plurality of adapter devices 17 or more than two containers 1, 9. This results in a simple, reliable and clear operation, 35 in which the vaccinating agent 21 is prepared using only one adapter device 17, thus effec tively preventing mix-ups with other starting materials and the introduction of impurities or pathogens.

- 16 These positive properties can be further enhanced if the first container 1, optionally with the adapter device 17, is configured to be used directly in the injection device 22, particu larly in an injection gun, in a pressure injector and/or in a self-filling syringe (cf. Figure 7) or with these devices. The first container 1 can thus be used in or with a preferably multi 5 ple-use injection device 22. This means that each closure device 5, 14 only has to be pierced or penetrated on a first and only occasion. This allows a high degree of safety of use, ease of handling and hygiene. It may be envisaged that the first container 1 is configured for use in or with an injection 10 device 22 in a neck or mouth region, particularly in the opening region 3, for connection to an in particular multiple-use injection device 22. The injection device 22 may have a re ceptacle 23 for the first container 1. It may be provided that the longitudinal extent and/or the diameter of the first container 1 is configured for use in an injection device 22 that is, in particular, designed for multiple use. For example, the first container 1 may have a di 15 ameter of more than 1 cm, preferably more than 2 cm, particularly more than 3 cm and/or less than 10 cm, preferably less than 8 cm, particularly less than 6 cm. Alternatively or ad ditionally it is possible for the first container 1 to have a longitudinal extent which is more than 3 cm, preferably more than 5 cm, particularly more than 6 cm and/or less than 30 cm, preferably less than 25 cm, particularly less than 20 cm. 20 As soon as the second starting material 10 has passed through the adapter device 17 into the first container 1, vaccinating agent 21 can be formed. It is possible that the vaccinating agent 21 is produced by mixing the starting materials 7, 10, by dissolving the starting ma terials 7, 10 in one another and/or by reacting the starting materials 7, 10 or parts thereof 25 with one another. Preferably, as shown by the arrow in Figure 6, the first container 1 hold ing the starting materials 7, 10 is set in motion, particularly shaken, titled, set in rotation or the like. This ensures or assists with homogeneous and/or faster mixing, reaction and/or dissolving. 30 In the embodiment shown the first starting material 7 and/or the second starting material 10 comprises vaccine preferably in amounts of more than 30 per cent by weight, prefera bly more than 40 per cent by weight, particularly more than 50 per cent by weight; and/or less than 90 per cent by weight, preferably less than 80 per cent by weight, particularly less than 70 per cent by weight Moreover, the first starting material 7, the second starting 35 material 10, and/or the vaccinating agent 21 formed thereby may be a suspension, prefer ably with vaccines and/or insoluble proteins, preferably in amounts of more than 30 per cent by weight, preferably more than 40 per cent by weight, particularly more than 50 per cent by weight; and/or less than 90 per cent by weight, preferably less than 80 per cent by weight, particularly less than 70 per cent by weight This ensures an efficacy, with small 40 amounts of vaccinating agent and at the same time low enough viscosity, which assists with administration.

- 17 The second starting material 10 preferably comprises only the other one of the compo nents Mycoplasma vaccine or Mycoplasma antigen and Circovirus vaccine or Circovirus antigen. It is also preferable if the first starting material 7 comprises Mycoplasma vaccine 5 or one or more Mycoplasma antigens, the first starting material 7 does not comprise Circovirus vaccine or Circovirus antigen, but for this purpose the second starting material 10 comprises Circovirus vaccine or one or more Circovirus antigens, but not Mycoplasma vaccine or Mycoplasma antigen. However, it is not ruled out, for any of the starting materi als 7, 10, that the particular starting material should not contain additional substances. 10 These might be water, excipients, adjuvants, preservatives or the like. In one embodiment the ratio by volume of the first starting material 7 to the second start ing material 10 is 3:1 to 1:3, preferably 2:1 to 1:2, particularly about 1:1. The first starting material 7 and/or the second starting material 10 and/or the vaccinating agent 21 may 15 have a viscosity that is less than 10,000 mPa-s, preferably less than 1000 mPa-s, particular ly less than 500 mPa-s; and/or more than 5 mPa-s, preferably more than 10 mPa-s, particu larly more than 20 mPa-s, measured with a Brookfield viscometer according to EN ISO 2555 at 5'C. Preferably, the first starting material 7 and/or the second starting material 10 are liquid at 2'C to 8'C and/or have a melting point which is less than 1C, preferably less 20 than 0 0 C, particularly less than -0.2'C and/or higher than -1.5'C, preferably higher than 1C, particularly higher than -0.8'C. According to another aspect of the present invention it is preferable that the vaccinating agent 21 has a characteristic colour which is different from the two starting materials 7, 25 10. The specific colour of the vaccinating agent may be formed for example by mixing the differently coloured starting materials 7 and 10. For example, mixing a yellow starting ma terial 7 with a red starting material 10 results in a vaccinating agent 21 that is orange in colour. It is possible for dye components in the starting materials 7, 10 to produce the characteristic colour by reaction or other interactions during the preparation of the vac 30 cinating agent 21. Alternatively or additionally the vaccinating agent 21, in contrast to at least one of the starting materials 7, 10, may have one colour or no colour. As a result, by means of the characteristic colour, it is possible to ensure that the vaccinating agent 21 has been successfully prepared. This is also possible if at least one of the starting materials has a colour but, once prepared, the vaccinating agent 21 does not. 35 As already stated above, the Mycoplasma vaccine may comprise attenuated and/or inacti vated bacteria, fragments of bacteria or recombinantly prepared parts of Mycoplasma hy opneumoniae, but at least one or more Mycoplasma hyopneumoniae antigens. Preferably, the Mycoplasma hyopneumoniae antigen originates from the Mycoplasma hyopneumoniae 40 strain J, or the inactivated Mycoplasma hyopneumoniae bacteria are those of the strain J.

- 18 Moreover, the Mycoplasma vaccine may be one of the following vaccines or the Myco plasma hyopneumoniae antigen may be the antigens contained in one of the following vaccines: Ingelvac@MycoFlex (Boehringer Ingelheim Vetmedica Inc, St Joseph, MO, USA), Porcilis M. hyo, Myco Silencer@ BPM, Myco Silencer@ BPME, Myco Silencer@ ME, Myco Si 5 lencer@ M, Myco Silencer@ Once, Myco Silencer@ MEH (all obtainable from Intervet Inc., Millsboro, USA) Stellamune Mycoplasma (Pfizer Inc., New York, NY, USA), Suvaxyn Myco plasma, Suvaxyn M. hyo, Suvaxyn MH-One (all formerly from Fort Dodge Animal Health, Overland Park, KS, USA (now Pfizer Animal Health). 10 The Circovirus vaccine may comprise attenuated and/or inactivated porcine Circovirus, preferably type 2, particularly type 2 ORF2 protein. It is particularly preferable to use re combinantly expressed ORF2 protein of Porcine Circovirus type 2, preferably expressed in and/or obtained from in vitro cell culture. Examples of ORF2 proteins of Porcine Circovirus type 2 are described inter alia in International Patent Application W02006 15 072065. These have proved particularly advantageous for effective vaccination. Moreover, the Circovirus vaccine may be one of the following vaccines, or the Circovirus antigen may be the antigen or antigens present in one of the following vaccines: Ingelvac@CircoFLEX, (Boehringer Ingelheim Vetmedica Inc, St Joseph, MO, USA), CircoVac@ (Merial SAS, Lyon, France), CircoVent (Intervet Inc., Millsboro, DE, USA), or Suvaxyn PCV-2 One Dose@ (Fort 20 Dodge Animal Health, Kansas City, KA, USA). The Circovirus vaccine, if it contains the ORF2 protein, preferably contains between 2 ig and 150 ig, preferably between 2 ig and 60 g, more preferably between 2 ig and 50 g, more preferably between 2 g and 40 rig, more preferably between 2 ig and 30 tg, more 25 preferably between 2 g and 25 ig, more preferably between 2 g and 20 ig, more prefer ably between 4 ig and 20 rig, more preferably between 4 ig and 16 ig of ORF2 protein per dose to be administered. The Circovirus vaccine is preferably prepared or designed so that 1 ml of the vaccine corresponds to a dose of 1 and/or one (single) dose. 30 The Mycoplasma vaccine, if it contains inactivated Mycoplasma bacteria, preferably inacti vated Mycoplasma hyopneumoniae bacteria, preferably contains between 103 and 109 col ony forming units (CFU), preferably between 104 and 108 (CFU), more preferably between 10s and 106 (CFU) per dose to be administered, the corresponding CFU being adjusted be fore the inactivation of the bacteria. The Mycoplasma vaccine is preferably prepared or 35 designed so that 1 ml of the vaccine corresponds to a dose of 1 and/or one (single) dose. The Mycoplasma vaccine may preferably comprise attenuated and/or inactivated bacteria or fragments of bacteria of the strain Mycoplasma hyopneumoniae or corresponding anti gens, preferably in amounts of more than 30 per cent by weight, preferably more than 40 - 19 per cent by weight, particularly more than 50 per cent by weight; and/or less than 90 per cent by weight, preferably less than 80 per cent by weight, particularly less than 70 per cent by weight 5 The Circovirus vaccine may preferably comprise attenuated and/or inactivated Porcine Circovirus, preferably type 2, particularly Porcine Circovirus type 2 ORF2 protein or cor responding antigens, preferably in amounts of more than 30 per cent by weight, prefera bly more than 40 per cent by weight, particularly more than 50 per cent by weight; and/or less than 90 per cent by weight, preferably less than 80 per cent by weight, particularly 10 less than 70 per cent by weight Moreover, at least one of the starting materials 7, 10 and/or the vaccinating agent 21 may comprise one, preferably polymeric, adjuvant, particularly carbomer. Preferably one of the two starting materials or, more preferably both starting materials, contain an amount of 15 adjuvant of from 500 ig to 5 mg, preferably from 750 ig to 2.5 mg, more preferably about 1 mg per dose to be administered. The starting materials are preferably prepared or de signed so that 1 ml of the respective starting material corresponds to a dose of 1 and/or one (single) dose. In particular, at least one of the starting materials 7, 10 may thus com prise one or more adjuvants in a total amount of more than 500 ig/ml, preferably more 20 than 750 ig/ml and/or less than 5 mg/ml, preferably less than 2.5 mg/ml. It is also possible for at least one of the starting materials 7, 10 and/or the vaccinating agent 21 to contain an adjuvant in amounts of more than 0.1 per cent by weight, prefera bly more than 1 per cent by weight, particularly more than 2 per cent by weight; and/or 25 less than 20 per cent by weight, preferably less than 10 per cent by weight, particularly less than 5 per cent by weight It is also possible for a preferably polymeric adjuvant, par ticularly carbomer, to be formed in the vaccinating agent 21. The Mycoplasma vaccine and/or the Circovirus vaccine or at least one of the starting ma 30 terials 7, 10, and/or the vaccinating agent 21 may contain formaldehyde, preferably in a concentration of less than 2.5 mg/m 3 , preferably less than 1.5 mg/m 3 , particularly 0.74 mg/m 3 or less. Alternatively or additionally, at least one of the starting materials 7, 10, preferably both starting materials 7, 10, may contain water in a concentration of at least 20 per cent by weight, preferably at least 30 per cent by weight, particularly at least 40 per 35 cent by weight; and/or at most 80 per cent by weight, preferably at most 70 per cent by weight, particularly at most 60 per cent by weight - 20 The first starting material 7, the second starting material 10 and/or the vaccinating agent 21 may comprise one or more excipients, particularly a preservative, an antioxidant and/or an emulsifier, preferably in a concentration of at least 0.1 per cent by weight, pref erably at least 0.2 per cent by weight, particularly at least 0.3 per cent by weight; and/or at 5 most 10 per cent by weight, preferably at most 5 per cent by weight, particularly at most 3 per cent by weight. The preferred use of the present invention is in the preparation of the vaccinating agent 21 from two vaccines, particularly preferably the preparation of a vaccinating agent 21 for 10 use in the in particular simultaneous immunisation against Porcine Circovirus Disease "PCVD" and/or Enzootic Pneumonia "EP" or against infection with Porcine Circovirus and/or with Mycoplasma bacteria, preferably for use in immunisation against the disease Porcine Circovirus Disease "PCVD" and Enzootic Pneumonia "EP" or against infection with Porcine Circovirus, particularly type 2, and with Mycoplasma bacteria, particularly Myco 15 plasma hyopneumoniae. Moreover, the present invention relates primarily to vaccinating agents for veterinary medicine, particularly for use in pigs. However, the present invention is not restricted to this combination. In particular, it is possible to use the proposed kit with other starting materials, particularly vaccines or an 20 tigens, such as for example with antigens of the pathogens described above. Here, too, it may be possible to achieve similar advantages at least in respect of ease of use and espe cially hygienic use. The same also applies to the aspect of the present invention that the vaccinating agent 21 prepared has a different colour from the starting materials 7, 10, thus providing an efficient, simple and effective method of checking that the vaccinating agent 25 21 has been successfully prepared. The specific colour of the vaccinating agent may result for example from mixing the differently coloured starting materials 7 and 10. For example, mixing a yellow starting material 7 with a red starting material 10 leads to a vaccinating agent 21 that is orange in colour. The use of the first container 1 with an injection device 22 may also be applied successfully and advantageously to other fields, wherein similar 30 advantages may be achieved particularly in respect of improved hygiene and/or reduced use of materials. However, it is particularly preferable to combine the proposed kit with a characteristic colour for the vaccinating agent 21 prepared which is different from the col ours of the starting materials 7, 10. This results in an exceptionally high degree of certain ty in use. However, the individual aspects of the present invention may also be combined 35 in any other desired manner.

-21 Reference numerals: 1 first container 2 wall 5 3 opening region 4 flange 5 closure device 6 clamping element 7 first starting material 10 8 gas 9 second container 10 second starting material 11 wall 12 opening region 15 13 flange 14 closure device 15 clamping element 16 gas 17 adapter device 20 18 adapter element 19 fluid channel 20 venting and/or exhaust device 21 vaccinating agent 22 injection device 25 23 receptacle 24 living creature

Claims

1. Kit for preparing a vaccinating agent, particularly a kit for preparing a vaccinating agent for use in immunisation against the disease Porcine Circovirus Disease "PCVD" 5 and/or Enzootic Pneumonia "EP", the kit comprising a first starting material, a second starting material different from the first, a first container only partly filled with the first starting material, a second container comprising the second starting material and prefera bly an adapter device for providing a fluid connection between the first and second con tainer, 10 wherein at least one of the containers is closed off on the operating side with a closure de vice and the second container is connectable to the first container by means of the adapter device by piercing the closure device for the first and/or only time, such that the second starting material enters the first container and there forms the vaccinating agent with the 15 first starting material.

2. Kit according to claim 1, characterised in that the first and/or second starting materi al is or comprises a vaccine. 20

3. Kit according to claim 1 or 2, characterised in that the first starting material differs from the second starting material.

4. Kit according to one of the preceding claims, characterised in that the first starting material comprises a first vaccine and the second starting material comprises a second 25 vaccine different from the first vaccine.

5. Kit according to one of the preceding claims, characterised in that the first starting material comprises only a first of the components Mycoplasma vaccine and Circovirus vaccine, preferably in amounts of more than 30 % by weight, preferably more than 40 % 30 by weight, particularly more than 50 % by weight; and/or less than 90 % by weight, pref erably less than 80 % by weight, particularly less than 70 % by weight.

6. Kit according to claim 5, characterised in that the second starting material comprises only the other of the components Mycoplasma vaccine and Circovirus vaccine. 35 - 23

7. Kit according to one of the preceding claims, characterised in that the second starting material comprises only one of the components Mycoplasma vaccine and Circovirus vac cine, preferably in amounts of more than 30 % by weight, preferably more than 40 % by weight, particularly more than 50 % by weight; and/or less than 90 % by weight, prefera 5 bly less than 80 % by weight, particularly less than 70 % by weight.

8. Kit according to one of the preceding claims, characterised in that the first starting material, the second starting material and/or the vaccinating agent is a suspension, pref erably with vaccines and/or insoluble proteins, preferably in amounts of more than 30 % 10 by weight, preferably more than 40 % by weight, particularly more than 50 % by weight; and/or less than 90 % by weight, preferably less than 80 % by weight, particularly less than 70 % by weight.

9. Kit according to one of the preceding claims, characterised in that the ratio by volume 15 of the first starting material to the second starting material is 3:1 to 1:3, preferably 2:1 to 1:2, particularly about 1:1.

10. Kit according to one of the preceding claims, characterised in that the first starting material and/or the second starting material and/or the vaccinating agent has a viscosity 20 that is less than 10000 mPa-s, preferably less than 1000 mPa-s, particularly less than 500 mPa-s; and/or higher than 5 mPa-s, preferably higher than 10 mPa-s, particularly higher than 20 mPa-s, measured with a Brookfield viscometer according to EN ISO 2555 at 5 0 C.

11. Kit according to one of the preceding claims, characterised in that the first and/or 25 second starting material is liquid at 2'C to 8'C; and/or has a melting point of less than 1C, preferably less than 0 0 C, particularly less than -0.2'C; and/or higher than -1.5'C, prefera bly higher than -1.0 0 C, particularly higher than -0.8'C.

12. Kit according to one of the preceding claims, characterised in that the vaccinating 30 agent has a characteristic colour different from the two starting materials; and/or in that the vaccinating agent has a colour or no colour, in contrast to at least one of the starting materials.

13. Kit according to one of the preceding claims, characterised in that mixing one of the 35 starting materials with a third starting material that is different from the two starting ma terials produces no colour, or a colour that is different from the characteristic colour of the -24 vaccinating agent.

14. Kit according to one of the preceding claims, characterised in that the vaccinating agent is designed to prevent pigs from falling ill with Mycoplasma hyopneumoniae and/or 5 Porcine Circovirus type 2.

15. Kit according to one of the preceding claims, characterised in that the Mycoplasma vaccine contains one or more antigens of Mycoplasma hyopneumoniae, preferably in amounts of more than 30 % by weight, preferably more than 40 % by weight, particularly 10 more than 50 % by weight; and/or less than 90 % by weight, preferably less than 80 % by weight, particularly less than 70 % by weight.

16. Kit according to one of the preceding claims, characterised in that the Circovirus vac cine contains one or more antigens of Porcine Circovirus, preferably type 2, particularly 15 Porcine Circovirus type 2 ORF2 protein, preferably in amounts of more than 30 % by weight, preferably more than 40 % by weight, particularly more than 50 % by weight; and/or less than 90 % by weight, preferably less than 80 % by weight, particularly less than 70 % by weight. 20

17. Kit according to one of the preceding claims, characterised in that at least one of the starting materials and/or the vaccinating agent comprises a preferably polymeric adju vant, particularly carbomer.

18. Kit according to claim 17, characterised in that at least one of the starting materials 25 and/or the vaccinating agent comprises the adjuvant in amounts of more than 0.1 % by weight and/or less than 20 % by weight, preferably more than 1 % by weight and/or less than 10 % by weight, particularly more than 2 % by weight and/or less than 5 % by weight. 30

19. Kit according to one of the preceding claims, characterised in that a preferably poly meric adjuvant, particularly carbomer, is formed in the vaccinating agent.

20. Kit according to one of the preceding claims, characterised in that the Mycoplasma vaccine and/or the Circovirus vaccine contains formaldehyde in a concentration of less 35 than 2.5 mg/m 3 , preferably less than 1.5 mg/m 3 , particularly 0.74 mg/m 3 or less. - 25

21. Kit according to one of the preceding claims, characterised in that the first starting material contains water in a concentration of at least 20 % by weight, preferably at least 30 % by weight, particularly at least 40 % by weight; and/or at most 80 % by weight, 5 preferably at most 70 % by weight, particularly at most 60 % by weight.

22. Kit according to one of the preceding claims, characterised in that the first starting material contains one or more excipients, particularly preservatives, antioxidants and/or emulsifier, each preferably in a concentration of at least 0.1 % by weight, preferably at 10 least 0.2 % by weight, particularly at least 0.3 % by weight; and/or at most 10 % by weight, preferably at most 5 % by weight, particularly at most 3 % by weight.

23. Kit according to one of the preceding claims, characterised in that the total volume of the first container exceeds the volume of the first starting material at least by the volume 15 of the second starting material.

24. Kit according to one of the preceding claims, characterised in that the first container is filled with the first starting material in an amount of less than 70 %, preferably less than 50 %, particularly less than 45 %. 20

25. Kit according to one of the preceding claims, characterised in that the first container contains gas, preferably protective gas.

26. Kit according to claim 25, characterised in that the volume of the gas corresponds at 25 least to the volume of the second starting material in the second container.

27. Kit according to claim 25 or 26, characterised in that the volume of the gas in the first container exceeds the volume of the second starting material by more than 2 %, preferably more than 5 %, particularly more than 8 % and/or less than 80 %, preferably less than 50 30 %, particularly less than 40 % or 30 %.

28. Kit according to one of claims 25 to 27, characterised in that the adapter device is configured so that during the transfer of the second starting material into the first con tainer the gas or protective gas passes, particularly is transported, from the first container 35 into the second container. - 26

29. Kit according to one of the preceding claims, characterised in that the adapter device is configured for preferably fluidically connecting the inner spaces formed by the contain ers. 5

30. Kit according to one of the preceding claims, characterised in that the adapter device comprises a fluid channel for providing a fluidic connection between the inner spaces formed by the containers. 10

31. Kit according to one of the preceding claims, characterised in that the adapter device comprises a venting or exhaust device.

32. Kit according to claim 31, characterised in that the adapter device comprises a chan nel for venting or exhaust. 15

33. Kit according to claim 30 and according to claim 31 or 32, characterised in that the venting or exhaust device, particularly the channel for venting or exhaust, is provided in addition to the fluid channel of the adapter device, particularly parallel thereto. 20

34. Kit according to claim 30 and one of claims 31 to 33, characterised in that one open ing of the channel for venting or exhaust is set back, in respect of the outlet opening of the fluid channel on the side facing the first container, in the direction of the main extent of the adapter device, and/or 25 an opening of the channel for venting or exhaust facing the second container is arranged on the side of the outlet opening of the fluid channel facing the second container, which faces the second container, facing the open end of the adapter device. 30

35. Kit according to one of claims 31 to 34, characterised in that the venting or exhaust device is configured for in particular fluidically connecting the inner spaces formed by the containers. - 27

36. Kit according to one of the preceding claims, characterised in that the adapter device comprises two adapter elements forming a fluid channel and/or venting or exhaust device, associated with the containers, preferably configured as a transfer needle, hollow needle and/or spike. 5

37. Kit according to claim 36, characterised in that between the adapter elements is pro vided a tube or pipe, particularly moulded thereon, preferably for extending the fluid channel. 10

38. Kit according to one of the preceding claims, characterised in that the adapter device is configured to be specific to the first container and/or second container.

39. Kit according to claim 38, characterised in that at least one adapter element is config ured mechanically to be specific to one of the containers. 15

40. Kit according to claim 38 or 39, characterised in that the introduction of substances other than the first and/or second starting material into the first and/or second container is prevented. 20

41. Kit according to one of the preceding claims, characterised in that the adapter device is embodied to form a connection solely between the first and second container, particu larly with exclusion of the surrounding atmosphere.

42. Kit according to one of the preceding claims, characterised in that the second starting 25 material enters the first container under the effect of gravity.

43. Kit according to one of the preceding claims, characterised in that at least one of the containers, particularly the second container, is flexibly deformable. 30

44. Kit according to one of the preceding claims, characterised in that the first container, the second container, the closure device and/or the connecting device consists at least substantially of HDPE, EVA, halobutyl type 1 rubber and/or siliconised chlorobutyl. - 28

45. Kit according to one of the preceding claims, characterised in that the closure device comprises or consists of a rubber stopper.

46. Kit according to claim 45, characterised in that the rubber stopper comprises or at 5 least substantially consists of halobutyl type 1 rubber.

47. Kit according to one of the preceding claims, characterised in that for the preparation the first container, the second container and the adapter device form a sealed assembly, preferably with a common packaging. 10

48. Kit according to one of the preceding claims, characterised in that the vaccinating agent is intended for preventing disease in pigs caused by infection with porcine Circovirus type 2 and/or Mycoplasma hyopneumoniae. 15

49. Kit according to one of the preceding claims, characterised in that the first container can be used in or with a preferably multiple-use injection device, particularly an injection gun, pressure injector and/or self-filling syringe.

50. Kit according to one of the preceding claims, characterised in that, for use in or with a 20 particularly multiple-use injection device, particularly an injection gun, pressure injector and/or self-filling syringe, the first container can be connected in airtight manner to a re ceptacle of the injection device.

51. Kit according to one of the preceding claims, characterised in that the first container 25 is formed in a neck or mouth region, particularly by means of the closure device for con nection to a particularly multiple-use injection device, particularly an injection gun, pres sure injector and/or self-filling syringe.

52. Kit according to one of the preceding claims, characterised in that the longitudinal ex 30 tent and/or the diameter of the first container is designed for use in a particularly multi ple-use injection device, particularly an injection gun, pressure injector and/or self-filling syringe. - 29

53. Kit according to one of the preceding claims, characterised in that the first container has a diameter of more than 1 cm, preferably more than 2 cm, particularly more than 3 cm; and/or less than 10 cm, preferably less than 8 cm, particularly less than 6 cm. 5

54. Kit according to one of the preceding claims, characterised in that the first container has a longitudinal extent that is more than 3 cm, preferably more than 5 cm, particularly more than 6 cm and/or less than 30 cm, preferably less than 25 cm, particularly less than 20 cm. 10

55. Use of a kit, particularly according to one of the preceding claims, for producing and/or preparing a vaccinating agent, preferably for, in particular, simultaneous immun isation against the disease Porcine Circovirus Disease "PCVD" and/or Enzootic Pneumonia "EP". 15

56. Use of at least two starting materials for producing a vaccinating agent, preferably for, in particular, simultaneous immunisation against the disease Porcine Circovirus Disease "PCVD" and/or Enzootic Pneumonia "EP" in pigs, in which, in order to produce the vac cinating agent, the starting materials are placed in containers and used with an adapter device, particularly using a kit according to one of claims 1 to 54, 20 using a first starting material in a first container only partly filled with the first starting material and a second starting material different from the first in a second container com prising the second starting material, and an adapter device designed to provide a fluidic connection between the first and second container, 25 at least one of the containers being closed off on the operating side with a closure device and forming with the adapter device, when the closure device is pierced for the first and/or only time, a fluid connection between the first and second container, in order to transfer the second starting material through the adapter device and the closure device in 30 to the first container and produce the vaccinating agent in the first container.

57. Use according to one of claim 56, characterised in that the adapter device is used to penetrate the closure device. 35

58. Use according to claim 56 or 57, characterised in that the adapter device is used to penetrate the closure devices of both containers, preferably for the first and/or only time. - 30

59. Use according to one of claims 56 to 58, characterised in that the adapter device is used first to penetrate the closure device of the second container and then the closure de vice of the first container, preferably for the first and/or only time. 5

60. Use according to one of claims 56 to 59, characterised in that the adapter device is used to produce a fluid connection between the containers such that the starting material passes from the second container into the first container under the effect of gravity. 10

61. Use according to one of claims 56 to 60, characterised in that the first container is moved during and/or after the transfer of the second starting material into the first con tainer, in order to achieve and/or speed up homogeneous mixing.

62. Use according to one of claims 56 to 61, characterised in that the first container is 15 used with an injection device, more particularly is connected thereto.

63. Use according to one of claims 56 to 62, characterised in that the first container is used in or with a preferably multiple-use injection device, particularly an injection gun, pressure injector and/or self-filling syringe. 20

64. Use according to one of claims 56 to 63, characterised in that the first container is configured for use in or with a preferably multiple-use injection device, particularly an in jection gun, pressure injector and/or self-filling syringe. 25

65. Use according to one of claims 56 to 64, characterised in that the first container is configured in a neck or mouth region for connection to a particularly multiple-use injec tion device, particularly an injection gun, pressure injector and/or self-filling syringe.

66. Use according to one of claims 56 to 65, characterised in that the longitudinal extent 30 and/or diameter of the first container is designed for use in a particularly multiple-use in jection device, particularly an injection gun, pressure injector and/or self-filling syringe. -31

67. Use according to one of claims 56 to 66, characterised in that the first container has a diameter of more than 1 cm, preferably more than 2 cm, particularly more than 3 cm and/or less than 10 cm, preferably less than 8 cm, particularly less than 6 cm. 5

68. Use according to one of claims 56 to 67, characterised in that the first container has a longitudinal extent which is more than 3 cm, preferably more than 5 cm, particularly more than 6 cm and/or less than 30 cm, preferably less than 25 cm, particularly less than 20 cm.

69. Use according to one of claims 56 to 68, characterised in that the first and/or second 10 starting material is or comprises a vaccine.

70. Use according to one of claims 56 to 69, characterised in that the first starting materi al differs from the second starting material. 15

71. Use according to one of claims 56 to 70, characterised in that the first starting materi al comprises a first vaccine and the second starting material comprises a second vaccine that is different from the first vaccine.

72. Use according to one of claims 56 to 71, characterised in that the first starting materi 20 al comprises only a first of the components Mycoplasma vaccine and Circovirus vaccine, preferably in amounts of more than 30 % by weight, preferably more than 40 % by weight, particularly more than 50 % by weight; and/or less than 90 % by weight, preferably less than 80 % by weight, particularly less than 70 % by weight. 25

73. Use according to one of claims 56 to 72, characterised in that the second starting ma terial comprises only the other of the components Mycoplasma vaccine and Circovirus vaccine.

74. Use according to one of claims 56 to 73, characterised in that the second starting ma 30 terial comprises only one of the components Mycoplasma vaccine and Circovirus vaccine, preferably in amounts of more than 30 % by weight, preferably more than 40 % by weight, particularly more than 50 % by weight; and/or less than 90 % by weight, preferably less than 80 % by weight, particularly less than 70 % by weight. - 32

75. Use according to one of claims 56 to 74, characterised in that the first starting materi al, the second starting material and/or the vaccinating agent is a suspension, preferably with vaccines and/or insoluble proteins, preferably in amounts of more than 30 % by weight, preferably more than 40 % by weight, particularly more than 50 % by weight; 5 and/or less than 90 % by weight, preferably less than 80 % by weight, particularly less than 70 % by weight

76. Use according to one of claims 56 to 75, characterised in that the ratio by volume of the first starting material to the second starting material is 3:1 to 1:3, preferably 2:1 to 1:2, 10 particularly about 1:1.

77. Use according to one of claims 56 to 76, characterised in that the first starting materi al and/or the second starting material and/or the vaccinating agent has a viscosity which is less than 10000 mPa-s, preferably less than 1000 mPa-s, particularly less than 500 15 mPa-s; and/or higher than 5 mPa-s, preferably higher than 10 mPa-s, particularly higher than 20 mPa-s, measured with a Brookfield viscometer according to EN ISO 2555 at 5 0 C.

78. Use according to one of claims 56 to 77, characterised in that the first and/or second starting material is liquid at 2'C to 8'C; and/or has a melting point of less than 1C, prefer 20 ably less than 0 0 C, particularly less than -0.2'C and/or higher than -1.5'C, preferably high er than -1.0 0 C, particularly higher than -0.8'C.

79. Use according to one of claims 56 to 78, characterised in that the vaccinating agent has a characteristic colour different from both starting materials; and/or in that the vac 25 cinating agent has a colour or no colour, in contrast to at least one of the starting materi als.

80. Use according to one of claims 56 to 79, characterised in that mixing one of the start ing materials with a third starting material different from the two starting materials pro 30 duces no colour or a different colour from the one that is characteristic of the vaccinating agent

81. Use according to one of claims 56 to 80, characterised in that the vaccinating agent is intended for preventing disease in pigs caused by infection with Mycoplasma hyopneu 35 moniae and/or Porcine Circovirus type 2. - 33

82. Use according to one of claims 56 to 81, characterised in that the Mycoplasma vaccine contains one or more antigens of Mycoplasma hyopneumoniae, preferably in amounts of more than 30 % by weight, preferably more than 40 % by weight, particularly more than 50 % by weight; and/or less than 90 % by weight, preferably less than 80 % by weight, 5 particularly less than 70 % by weight

83. Use according to one of claims 56 to 82, characterised in that the Circovirus vaccine contains one or more antigens of Porcine Circovirus, preferably type 2, particularly por cine Circovirus type 2 ORF2 protein, preferably in amounts of more than 30 % by weight, 10 preferably more than 40 % by weight, particularly more than 50 % by weight; and/or less than 90 % by weight, preferably less than 80 % by weight, particularly less than 70 % by weight

84. Use according to one of claims 56 to 83, characterised in that at least one of the start 15 ing materials and/or the vaccinating agent comprises a preferably polymeric adjuvant, particularly carbomer.

85. Use according to claim 84, characterised in that at least one of the starting materials and/or the vaccinating agent comprises the adjuvant in amounts of more than 0.1 % by 20 weight and/or less than 20 % by weight, preferably more than 1 % by weight and/or less than 10 % by weight, particularly more than 2 % by weight and/or less than 5 % by weight

86. Use according to one of claims 56 to 85, characterised in that a preferably polymeric 25 adjuvant, particularly carbomer, is formed in the vaccinating agent

87. Use according to one of claims 56 to 86, characterised in that the Mycoplasma vaccine and/or the Circovirus vaccine contains formaldehyde in a concentration of less than 2.5 mg/m 3 , preferably less than 1.5 mg/m 3 , particularly 0.74 mg/m 3 or less. 30

88. Use according to one of claims 56 to 87, characterised in that the first starting materi al contains water in a concentration of at least 20 % by weight, preferably at least 30 % by weight, particularly at least 40 % by weight; and/or at most 80 % by weight, preferably at most 70 % by weight, particularly at most 60 % by weight 35 -34

89. Use according to one of claims 56 to 88, characterised in that the first starting materi al contains one or more excipients, particularly preservatives, antioxidants and/or emulsi fier, each preferably in a concentration of at least 0.1 % by weight, preferably at least 0.2 % by weight, particularly at least 0.3 % by weight; and/or at most 10 % by weight, prefer 5 ably at most 5 % by weight, particularly at most 3 % by weight

90. Use according to one of claims 56 to 89, characterised in that the total volume of the first container exceeds the volume of the first starting material at least by the volume of the second starting material. 10

91. Use according to one of claims 56 to 90, characterised in that the first container is filled with the first starting material by an amount of less than 70 %, preferably less than 50%, particularly less than 45 %. 15

92. Use according to one of claims 56 to 91, characterised in that the first container con tains gas, preferably protective gas.

93. Use according to claim 92, characterised in that the volume of the gas corresponds at least to the volume of the second starting material in the second container. 20

94. Use according to claim 92 or 93, characterised in that the volume of the gas in the first container exceeds the volume of the second starting material by more than 2 %, preferably more than 5 %, particularly more than 8 % and/or less than 80 %, preferably less than 50 %, particularly less than 40 % or 30 %. 25

95. Use according to one of claims 92 to 94, characterised in that the adapter device is configured so that during the transfer of the second starting material into the first con tainer the gas or protective gas passes, particularly is transported, from the first container into the second container. 30

96. Use according to one of claims 56 to 95, characterised in that the adapter device is configured for preferably fluidically connecting the inner spaces formed by the containers. - 35

97. Use according to one of claims 56 to 96, characterised in that the adapter device com prises a fluid channel for providing a fluidic connection between the inner spaces formed by the containers. 5

98. Use according to claim 98, characterised in that the adapter device comprises a vent ing or exhaust device.

99. Use according to one of claims 56 to 98, characterised in that the adapter device comprises a channel for venting or exhaust. 10

100. Use according to claim 97 and claim 98 or 99, characterised in that the venting or exhaust device, particularly the channel for venting or exhaust, is provided in addition to the fluid channel of the adapter device, particularly parallel thereto. 15

101. Use according to claim 97 and one of claims 98 to 100, characterised in that one opening of the channel for venting or exhaust is set back, in respect of the outlet opening of the fluid channel on the side facing the first container, in the direction of the main extent of the adapter device. 20

102. Use according to one of claims 97 to 101, characterised in that the venting or ex haust device is configured for in particular fluidically connecting the inner spaces formed by the containers.

103. Use according to one of claims 97 to 102, characterised in that the adapter de 25 vice comprises two adapter elements forming a fluid channel and/or venting or exhaust device, associated with the containers, preferably configured as a transfer needle, hollow needle and/or spike.

104. Use according to claim 103, characterised in that between the adapter elements 30 is provided a tube or pipe, particularly moulded thereon, preferably for extending the fluid channel. - 36

105. Use according to one of claims 56 to 104, characterised in that the adapter de vice, particularly an adapter element, is configured to be specific to the first container and/or second container. 5

106. Use according to claim 104 or 105, characterised in that at least one adapter el ement is configured mechanically to be specific to one of the containers.

107. Use according to one of claims 56 to 106, characterised in that the introduction of substances other than the first and/or second starting material into the first and/or 10 second container is prevented.

108. Use according to one of claims 56 to 107, characterised in that the adapter de vice is embodied to form a connection solely between the containers, particularly with ex clusion of the surrounding atmosphere. 15

109. Use according to one of claims 56 to 108, characterised in that the second start ing material enters the first container under the effect of gravity.

110. Use according to one of claims 56 to 109, characterised in that at least one of the 20 containers, particularly the second container, is flexibly deformable.

111. Use according to one of claims 56 to 110, characterised in that the first container, the second container, the closure device and/or the connecting device consists at least substantially of HDPE, EVA, halobutyl type 1 rubber and/or siliconised chlorobutyl. 25

112. Use according to one of claims 56 to 111, characterised in that the closure device comprises or consists of a rubber stopper.

113. Use according to claim 112, characterised in that the rubber stopper comprises 30 or at least substantially consists of halobutyl type 1 rubber. - 37

114. Use according to one of claims 56 to 113, characterised in that for the prepara tion the first container, the second container and the adapter device form a sealed assem bly, preferably with a common packaging. 5

115. Use according to one of claims 56 to 114, characterised in that the vaccinating agent is intended for preventing disease in pigs caused by infection with porcine Circovirus type 2 and/or Mycoplasma hyopneumoniae.

116. Process for preparing a vaccinating agent from a first starting material and with 10 a second starting material different from the first, preferably for, in particular, simultane ous immunisation against the disease Porcine Circovirus Disease "PCVD" and/or Enzootic Pneumonia "EP", particularly with a kit according to one of claims 1 to 54, wherein between a first container only partly filled with the first starting material and a 15 second container comprising the second starting material a fluid connection is formed by an adapter device, such that, by means of the adapter device, when at least one closure de vice provided on the operating side of at least one of the containers is pierced for the first and/or only time a fluid connection is formed between the first and second container, and 20 the second starting material is conveyed through the adapter device and the closure de vice into the first container, and in the first container the vaccinating agent is formed from the first and second starting ma terial. 25

117. Process according to claim 116, characterised in that closure devices of both containers are penetrated with the adapter device, preferably for the first and/or only time. 30

118. Process according to claim 116 or 117, characterised in that first the closure de vice of the second container and then the closure device of the first container is penetrated by the adapter device, preferably for the first and/or only time, or vice versa.

119. Process according to one of claims 116 to 118, characterised in that a fluid con 35 nection is provided between the containers such that the second starting material passes from the second container into the first container under the effect of gravity. - 38

120. Process according to one of claims 116 to 119, characterised in that the first con tainer is moved during and/or after the transfer of the second starting material into the first container, so as to achieve or speed up a homogeneous reaction, particularly dissolv 5 ing or mixing.

121. Process according to one of claims 116 to 120, characterised in that the first con tainer is placed in or on an injection device. 10

122. Process according to one of claims 116 to 121, characterised in that the first con tainer is placed in or on a preferably multiple-use injection device, particularly an injection gun, pressure injector and/or self-filling syringe.