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 (μg/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 ≥24 months. Detectable antibody (≥0.125 μg/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 <12 month old. The vaccine was immunogenic as early as 3–5 months of age. The need for booster immunization needs to be assessed.