Abstract: Provided herein are combination vaccines comprising antigens for protecting a subject against at least diphtheria, tetanus, pertussis and Hib, wherein: (a) the antigen for protecting against Hib is a conjugate of a Hib capsular saccharide; (b) the concentration of the Hib conjugate in the vaccine is <15 ?g/ml; and (c) the Hib conjugate has never been lyophilised.

Abstract: Influenza vaccines include hemagglutinin from at least one influenza A virus strain and at least one influenza B virus strain. They also include an oil-in-water emulsion adjuvant with submicron oil droplets, comprising squalene. In some embodiments the hemagglutinin concentration is >12 ?g/ml per strain. In some embodiments the squalene concentration is <19 mg/ml. In some embodiments the vaccine is mercury-free. In some embodiments the vaccine has a unit dose volume between 0.2-0.3 mL. In some embodiments the squalene concentration is 9.75 mg/mL or 4.88 mg/mL. In some embodiments the vaccine includes antigens from two influenza A virus strains and two influenza B virus strains.

Abstract: Factor H binding protein (fHBP) has been proposed for use in immunising against serogroup B meningococcus (‘MenB’). This antigen can be efficiently adsorbed to an aluminium hydroxyphosphate adjuvant by (i) ensuring that adsorption takes place at a pH which is equal to or below the adjuvant's point of zero charge (PZC), and/or (ii) selecting a fHBP and adjuvant with an isoelectric point/PZC within the range of 5.0 to 7, and/or (iii) selecting a fHBP with an isoelectric point above the adjuvant's PZC and using a buffer to bring the pH to within 1.2 pH units of the PZC. The adsorption is particularly useful for compositions which include multiple fHBP variants, and also in situations where an aluminium hydroxide adjuvant should be avoided. Buffered pharmaceutical compositions can include at least two different meningococcal fHBP antigens, both of which are at least 85% adsorbed to aluminium hydroxyphosphate adjuvant.

Abstract: An aqueous immunogen formulation is used to reconstitute a lyophilised component including conjugates of capsular saccharides from Neisseria meningitidis serogroups A, C, W135 and Y, thereby producing a combined vaccine. The aqueous formulation can include various immunogens but does not include a Hib conjugate.

Abstract: A liquid D-T-Pa component is used to reconstitute a lyophilised meningococcal component, thereby producing a combined vaccine.

Abstract: A dual formulation for vaccines against Neisseria meningitidis serogroup B (‘Men-B’) comprises (i) an oil-in-water emulsion adjuvant and (ii) a Men-B immunogenic component in lyophilised form. The lyophilised Men-B antigens can be reconstituted into liquid adjuvanted form at the time of use ready for administration to a patient. This formulation has been found to give excellent result in terms of both stability and immunogenicity. The lyophilised component can also include one or more conjugated saccharides from N. meningitidis in serogroups A, C, W135 and/or Y.

Abstract: Processes for preparing combination vaccines that include diphtheria and tetanus toxoids, where these two toxoids are used in the processes as a single component containing both toxoids, and also containing 1-hydroxy-2-phenoxyethane.

Abstract: A liquid Hib component is used to reconstitute a lyophilised meningococcal component, thereby producing a combined meningitis vaccine. A lyophilised meningococcal component can also be reconstituted with an oil-in-water emulsion.

Abstract: To improve the stability of vaccines comprising aluminum salt(s), the invention uses the amino acid histidine. This can improve pH stability and adjuvant adsorption and can reduce antigen hydrolysis. Histidine is preferably present during adsorption to the aluminum salt(s). The antigen in the vaccine may be a protein or a saccharide and is preferably from N. meningitidis.

Abstract: The invention uses polypeptide antigens and/or OMVs to immunize against serogroups A, C, W135 and Y (and against serogroup Y in particular). Serogroup B polypeptides can achieve this protection, thus permitting a single polypeptide-based vaccine to be used for protecting against all of serogroups A, B, C, W135 and Y.

Abstract: Influenza vaccines with oil-in-water emulsion adjuvants are known. The amount of emulsion adjuvant required for an influenza vaccine can be reduced, thereby allowing more vaccines to be made from a given amount of emulsion, and/or minimizing the amount of emulsion that has to be produced for a given number of vaccine doses. These vaccines can conveniently be made by mixing (i) an oil-in-water emulsion and (ii) an aqueous preparation of an influenza virus antigen. In one aspect, substantially equal volumes of components (i) and (ii) are used; in another aspect, an excess volume of component (ii) is used. When using substantially equal volumes, component (ii) has a hemagglutinin concentration of more than 60 ?g influenza virus strain per ml. Components (i) and (ii) can be presented in kit form.

Abstract: A problem with stockpiling influenza vaccines is their short shelf life. Storage volume is another problem. The invention prepares and stockpiles bulk vaccine, and the bulk is stored under frozen conditions. Compared to final vaccine, the higher antigen concentration and absence of packaging materials (boxes, vials, etc.) in the bulk means that the storage space requirements are hugely reduced. A process for preparing an influenza vaccine bulk thus comprises the steps of: (a) preparing bulk vaccine antigen from a source of influenza virus; and (b) storing the bulk vaccine prepared in step (a) under frozen conditions.

Abstract: Inclusion of fatty adjuvants in vaccine compositions can cause difficulties with certain antigenic components, particularly with antigens that include a surfactant component. A method for preparing an immunogenic composition comprising an antigen and a fatty adjuvant involves purification of the antigen substantially in the absence of surfactant. Where surfactants cannot be avoided, the following are combined: (i) an antigen component that includes a surfactant and (ii) a fatty adjuvant component, to give a composition in which the weight ratio of said fatty adjuvant to said surfactant is less than 1000:1.

Abstract: Vaccines have been studied that comprise (a) D-T-Pw-HepB-Hib antigens and (b) one or more meningococcal conjugate antigens. A number of improvements and variations of these vaccines have been discovered. The vaccines can be prepared extemporaneously at the time of use by mixing together two components: (a) a first component comprising D, T, wP and HBsAg antigens; and (b) a second component comprising a Hib conjugate and one or more meningococcal conjugates.

Abstract: Provided herein are combination vaccines comprising antigens for protecting a subject against at least diphtheria, tetanus, pertussis and Hib, wherein: (a) the antigen for protecting against Hib is a conjugate of a Hib capsular saccharide; (b) the concentration of the Hib conjugate in the vaccine is <15 ?g/ml; and (c) the Hib conjugate has never been lyophilised.

Abstract: When preparing HBsAg for use in a combination vaccine, it is known to add a non-ionic detergent after the HBsAg has been purified. Adding detergents after purification of HBsAg is not optimal, however, as it requires a separate processing step during manufacture. Thus the invention uses them during HBsAg purification.

Abstract: Calcium phosphate is used as an adjuvant, with a high degree of antigen adsorption to the adjuvant. The invention is particularly useful for adjuvanting conjugated capsular saccharide antigens. Buffers, such as phosphate or histidine buffers, can advantageously be used in combination with the calcium phosphate, and compositions may have a pH in the range of 5.5 to 7.5.

Abstract: Conjugated capsular saccharides from meningococcal serogroups C, W135 and Y are safe and immunogenic in humans when combined in a single dose. This effect is retained when a conjugated capsular saccharide from serogroup A is added. These conjugated antigens can be stably combined in a single aqueous dose without the need for lyophilisation. Broad protection against serogroup B infection can be achieved by using a small number of defined polypeptide antigens. These polypeptide antigens can be combined with the saccharide antigens without loss of protective efficacy for any of the five serogroups. Efficacy if retained even if a Hib conjugate is added. The efficacy of a serogroup W135 conjugate is enhanced by addition of protein antigens derived from a serogroup B strain. Addition of a Hib conjugate to meningococcal conjugates enhances the overall activity against meningococcus serogroup W135.

Abstract: To improve the stability of vaccines comprising aluminum salt(s), the invention uses the amino acid histidine. This can improve pH stability and adjuvant adsorption and can reduce antigen hydrolysis. Histidine is preferably present during adsorption to the aluminum salt(s). The antigen in the vaccine may be a protein or a saccharide and is preferably from N. meningitidis.

Abstract: To improve the stability of vaccines comprising aluminum salt(s), the invention uses the amino acid histidine. This can improve pH stability and adjuvant adsorption and can be reduce antigen hydrolysis. Histidine is preferably presen during adsorption to the aluminium salt(s). The antigen in the vaccine may be a protein or a saccharide and is preferably from N. meningitidis.