Immunogenicity and safety of Haemophilus influenzae type b polysaccharide-Neisseria meningitidis conjugate vaccine in 7.5 micrograms liquid formulation: a comparison of three lots with the 15.0 micrograms lyophilized formulation. Study Group for 7.5 micrograms Liquid PedvaxHIB

Paul MendelmanP Kniskern


We conducted a multicenter, single-blind, randomized comparisons of the immunogenicity and safety of three manufacturing-scale lots of 7.5 micrograms liquid Haemophilus influenzae type b polysaccharide- Neisseria meningitidis conjugate vaccine (PRP-OMPC) and a single lot of 15.0 micrograms lyophilized PRP OMPC. A total of 908 infants were entered into the study. Each infant received two primary injections intramuscularly 2 months apart beginning at age 2-6 months and a booster injection at 12-15 months. Blood samples for serology were obtained before each injection and 1 month after the second and the booster dose. Immune responses were measured by radioimmunoassay. Approximately 80% of the infants achieved a titer > 1.0 micrograms ml-1 after the second primary dose of all four lots tested: the geometric mean titer (GMT) was ca 3 micrograms ml-1 for each vaccine group. After the booster dose, more than 90% of infants from each vaccine group had a titer > 1.0 microgram ml-1;GMTs ranged from 8 to 10 micrograms ml-1. No serious vaccine-associated adverse reactions were reported. Thus the 7.5 liquid PRP OMPC vaccine was at least as immunogenic and well tolerated as the 15.0 micrograms lyophilized vaccine.


Oct 1, 1992·The Pediatric Infectious Disease Journal·D M AmbrosinoR S Daum
Jun 1, 1992·The Journal of Infectious Diseases·M SantoshamG R Siber
Feb 1, 1992·The Journal of Pediatrics·M D DeckerP Palmer
Jun 1, 1983·The Journal of Infectious Diseases·H KäyhtyP H Mäkelä
Sep 1, 1993·The Journal of Infectious Diseases·D M GranoffT V Murphy

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Nov 11, 1998·Archives de pédiatrie : organe officiel de la Sociéte française de pédiatrie·G Huault
Apr 18, 2008·Statistics in Medicine·Jitendra GanjuAlessandra Anemona

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