Immunogenicity and Reactogenicity of Primary Immunization With a Novel Combined Haemophilus influenzae Type b and Neisseria meningitidis Serogroup C-Tetanus Toxoid Conjugate Vaccine Coadministered With a Diphtheria–Tetanus–Acellular Pertussis–Hepatitis B–Inactivated Poliovirus Vaccine at 2, 4 and 6 Months

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Abstract
This phase II study evaluated the immunogenicity and reactogenicity of primary vaccination with a novel Hib-MenC conjugate vaccine (GlaxoSmithKline [GSK] Biologicals) coadministered with DTPa-HBV-IPV (GSK Biologicals) at 2, 4 and 6 months. Healthy infants were randomized to receive Hib-MenC coadministered with DTPa-HBV-IPV (N = 117) or MenC-CRM (Wyeth) coadministered with DTPa-HBV-IPV/Hib (GSK Biologicals; N = 120) at 2, 4 and 6 months. Antibody concentrations were measured before vaccination and after doses 2 and 3. Solicited local and general symptoms, unsolicited symptoms and serious adverse events (SAEs) were recorded. All subjects in the Hib-MenC group had seroprotective titers of anti-PRP antibodies (≥0.15 μg/mL) and SBA-MenC titers (≥1:8) 1 month after the third dose. These responses were noninferior to those seen in the control group, in which a 99.1% seroprotection rate was observed for both Hib and MenC. At that time, anti-PRP and SBA-MenC GMTs were significantly higher in the Hib-MenC group (12.8 μg/mL and 2467.1 μg/mL, respectively) than in the control group (3.8 μg/mL and 1833.7 μg/mL). High seroprotection rates were already observed after the second dose of Hib-MenC; 96.4% and 100% of subjects were seroprotected to Hib and MenC, respectively. Immune responses to coadministered antigens were unimpaired; seroprotection/vaccine response rates ≥96.5% were recorded postdose 3 in the Hib-MenC group. No differences in reactogenicity were seen between the 2 study groups. Coadministration of a Hib-MenC conjugate vaccine with DTPa-HBV-IPV is well tolerated and immunogenic, and does not impair the immune response to any of the coadministered antigens.

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