title: Clinical experience with PedvaxHIB, a conjugate vaccine of Haemophilus influenzae type b polysaccharide--Neisseria meningitidis outer membrane protein.
abstract: PedvaxHIB, a Haemophilus influenzae type b (Hib) conjugate vaccine composed of Hib capsular polysaccharide covalently bound to an outer membrane protein complex of Neisseria meningitidis serogroup B, was evaluated for immunogenicity and safety in infants and children 2 months of age and older. A significant and consistent antibody response was seen after a single dose of the vaccine in all age groups, including infants as young as 2 months of age. In addition, the vaccine elicited a good booster response when given at 12 to 17 months of age. Subjects from diverse subpopulations, including those with impaired antibody response to Hib polysaccharide vaccines, showed a significant response to vaccination. The vaccine was well tolerated when administered alone or concurrently with other paediatric vaccines. A protective efficacy study, recently completed, has shown the vaccine to be highly effective in 2-month-old infants.
authors.affiliation: Merck Sharp & Dohme Research Laboratories, West Point, Pennsylvania 19486.
authors.forename: V I
authors.initials: VI
authors.lastname: Ahonkhai
authors.forename: L J
authors.initials: LJ
authors.lastname: Lukacs
authors.forename: L C
authors.initials: LC
authors.lastname: Jonas
authors.forename: G B
authors.initials: GB
authors.lastname: Calandra
mesh_terms: D000907:Antibodies, Bacterial / Q000096:biosynthesis; D001425:Bacterial Outer Membrane Proteins / Q000009:adverse effects / Q000276:immunology; D001428:Bacterial Vaccines / Q000009:adverse effects / Q000276:immunology; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D018073:Haemophilus Vaccines; D006193:Haemophilus influenzae / Q000276:immunology*; D006801:Humans; D007223:Infant; D011135:Polysaccharides, Bacterial / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D001425:Bacterial Outer Membrane Proteins; D001428:Bacterial Vaccines; D018073:Haemophilus Vaccines; C061964:Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine; D011135:Polysaccharides, Bacterial