NOVELTY - A multi-valent immunogenic composition (I), comprising conjugate of a carrier protein and capsular polysaccharide (CP) of Haemophilus influenzae type B (HiB) and also comprises 2 or more bacterial polysaccharides capable of conferring protection to a host against infection by bacteria from which they are derived, where HiB CP conjugate is not adsorbed onto an aluminum adjuvant salt, is new.
USE - (I) is useful as a medicament, and in the manufacture of a medicament for treating or preventing diseases caused by infection by H. influenzae, or Bordetella pertussis, Clostridium tetani, Corynebacterium diphtheriae, hepatitis B virus, H. influenzae and N. meningitidis and also for immunizing a human host against disease caused by the above pathogens (claimed).
ADVANTAGE - (I) is formulated as a vaccine for in vivo administration to the host, where the individual components of the composition are formulated such that the immunogenicity of individual components is not impaired by other individual components of the composition, and (I) confers an antibody titer superior to the criterion for seroprotection for each antigenic component for an acceptable percentage of human subject. (All claimed). The new combination vaccine formulation minimizes the number of immunizations required to confer protection against multiple pathogens, to lower administration costs, and to increase acceptance and coverage rates.
DETAILED DESCRIPTION - An INDEPENDENT CLAIM is also included for (I) comprising either killed whole-cell Bordetella pertussis (Pw), or two or more acellular pertussis components, tetanus toxoid (TT), diphtheria toxoid (DT), hepatitis B surface antigen (HepB), a conjugate of a carrier protein and the capsular polysaccharide of HiB (where the amount of conjugate per 0.5 ml dose of bulk vaccine is 1-8 micrograms and the immunogenicity of the conjugate is equivalent or improved over such compositions comprising larger amounts of conjugate), and one or more conjugates of a carrier protein and a capsular polysaccharide of a bacterium such as Neisseria meningitidis type A and C.
