Safety and immunogenicity of a bivalent Haemophilus influenzae type b/hepatitis B vaccine in healthy infants

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Abstract
To assess the safety, tolerability and immunogenicity of COMVAX™, a liquid, bivalent Haemophilus influenzae type b-hepatitis B vaccine, containing the polyribosylribitol phosphate (PRP)-Neisseria meningitidis outer membrane protein complex conjugate used in the Hib vaccine, PedvaxHIB®, and the yeast-derived hepatitis B surface antigen (HBsAg) used in the HB vaccine, RECOMBIVAX HB®. Eight hundred eighty-two healthy infants, ∼2 months of age, were enrolled in an open, multicenter (n = 11) clinical trial and randomized to receive either COMVAX™ (7.5 μg of PRP/5 μg of HBsAg in 0.5 ml) or concurrent injections of the liquid formulation of Pedvax-HIB® (P) (7.5 μg of PRP in 0.5 ml) and RECOMBIVAX HB® (R) (5 μg of HBsAg in 0.5 ml) at 2, 4 and 12 or 15 months of age. Safety and tolerability were monitored after each injection. The serum concentrations of anti-PRP and anti-HBs were determined at the time of each vaccination, 2 months after the second vaccination and 1 month after the third vaccination. COMVAX™ was well-tolerated and proved to be immunologically comparable with a series of concomitant P + R injections. There were no serious adverse experiences attributable to the study vaccines. The most commonly reported nonserious adverse experiences were all events prelisted on diary cards given to parents. These included generally mild and transient signs of inflammation at the injection site (pain/soreness, erythema, swelling/induration), somnolence and irritability. COMVAX™ is well-tolerated by healthy infants and can induce immunity against invasive Hib disease and HBV infection using only three injections compared with six injections if separate courses of monovalent Pedvax-HIB® and RECOMBIVAX HB® are given.