Immunogenicity and safety of a 12-valent pneumococcal conjugate vaccine in infants aged 6–10 weeks: a randomized double-blind active-controlled trial

Abstract

Background Pneumococcal diseases among children aged 0.35 μg/mL was lower for some serotypes in the GBP411 group than in the comparator group (6B: 20.83% vs. 39.22%, P=0.047 and 19A: 58.33% vs. 90.20%, P97% of the subjects in each group achieved IgG concentrations of ≥0.35 μg/mL for all 12 serotypes. Increased immunogenicity was observed for some serotypes that showed significant intergroup differences after administration of the primary doses but not after the booster dose. We also found no significant intergroup difference in the overall incidence of solicited local adverse events. Furthermore, the overall incidence of solicited systemic adverse events was significantly lower in the GBP411 group than in the comparator vaccine group (79.59% vs. 98.04%; P=0.003). Conclusion The GBP411 vaccine with a dosing schedule of 2p+1 may be immunogenic and safe for healthy infants.

Keywords

• 12-valent pneumococcal conjugate vaccine
• immunogenicity
• safety
• infant