Efficacy of PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)]
Protective efficacy demonstrated by PedvaxHIB in a high-risk population
In the Protective Efficacy Study, following the primary 2-dose regimen, the protective efficacy of lyophilized PedvaxHIB was estimated.
PedvaxHIBc was initially evaluated in a randomized, double-blind, placebo-controlled study of Native American (Navajo) infants (N=3,486).
Each infant in this study received 2 doses of either placebo or lyophilized PedvaxHIB, with the first dose administered at a mean of 8 weeks of age and the second administered approximately 2 months later; DTP and OPV were administered concomitantly.
At termination of the study, placebo recipients were offered vaccine. All original participants were then followed for two years and nine months.
Protective efficacy in such high-risk populations would be expected to be predictive of efficacy in other populations.
A booster dose of PedvaxHIB is required in infants who complete the primary 2-dose regimen before 12 months of age. This booster dose will help maintain antibody levels during the first 2 years of life when children are at highest risk for invasive Hib disease.
aEstimated from person-days at risk.
bSubjects in this portion of the study received 1 to 3 doses of PedvaxHIB.
cA lyophilized formulation was used in the study. A later study found the antibody response of Liquid PedvaxHIB to be comparable.
The antibody responses induced by each formulation of PedvaxHIB were similar.
CI, confidence interval; DTP, diphtheria and tetanus toxoids and pertussis [vaccine]; OPV, oral polio vaccine;
Hib, Haemophilus influenzae type b.