title: Immunogenicity and reactogenicity of Haemophilus influenzae type b-meningococcus group B outer membrane protein conjugate vaccine in children 2-60 months of age.
abstract: Haemophilus influenzae b - Neisseria meningitidis group B outer membrane protein conjugate vaccine (Hib-OMP) was given to 571 children 2-60 months of age. Two doses of Hib-OMP were given, 2 months apart, to 2-11 month old infants, and a single dose to children 12-60 month old. Sera were obtained from a subset of vaccinees at each immunization, and at follow-up 1 month and 1 year after immunization. Geometric mean antibody concentration (micrograms/ml) before and after full immunization were respectively 0.111 and 3.549 for 2-3 month old, 0.108 and 5.048 for 4-5 month old, 0.082 and 6.933 for 6-11 month old; they were 0.103 and 3.500 for 12-17 month old, 0.167 and 7.791 for 18-23 month old and 0.243 and 12.781 for children greater than or equal to 24 months. Detectable antibody (greater than or equal to 0.125 micrograms/ml) failed to develop in 2/399 (0.5%) after primary immunization, and 12/252 (4.8%) lost detectable antibody 1 year later. Six of these 12 infants were less than 12 month old. The vaccine was immunogenic as early as 3-5 months of age. The need for booster immunization needs to be assessed.
authors.affiliation: University of Arizona, Tucson.
authors.forename: Z M
authors.initials: ZM
authors.lastname: Shehab
authors.forename: P
authors.initials: P
authors.lastname: Azimi
authors.forename: B I
authors.initials: BI
authors.lastname: Asmar
authors.forename: M G
authors.initials: MG
authors.lastname: Dunphy
authors.forename: E M
authors.initials: EM
authors.lastname: Ayoub
authors.forename: A S
authors.initials: AS
authors.lastname: Dajani
mesh_terms: D000367:Age Factors; D000907:Antibodies, Bacterial / Q000096:biosynthesis* / Q000097:blood; D001425:Bacterial Outer Membrane Proteins / Q000276:immunology*; D001428:Bacterial Vaccines / Q000276:immunology*; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D018073:Haemophilus Vaccines; D006193:Haemophilus influenzae / Q000276:immunology*; D006801:Humans; D007114:Immunization; D007223:Infant; D008297:Male; D009345:Neisseria meningitidis / Q000276:immunology*; D011135:Polysaccharides, Bacterial / Q000276:immunology*; D014614:Vaccines, Synthetic / 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; D014614:Vaccines, Synthetic