Phase 3, double-blind, active-controlled, multicenter trial involving 666 infants randomized to receive 4 doses of Prevnar 13® (n=334) or Prevnar® (PCV7)^‡ (n=332) given at 2, 4, 6, and 12 to 15 months of age. A total of 294 infants in the Prevnar 13® group completed the first 3 doses, of which 252 were evaluable for immunogenicity. A total of 264 toddlers received the fourth dose of Prevnar 13®, of which 239 were evaluable for immunogenicity. Pneumococcal antipolysaccharide IgG GMCs were calculated from blood samples taken 1 month after the third dose, before the fourth dose, and 1 month after the fourth dose. The mean age at the fourth dose in this study was 12.4 months.¹

Prevnar 13® effectiveness against IPD was inferred using comparative immunogenicity results from Prevnar® (PCV7)^‡.²

• When measured 1 month following the third dose, the noninferiority criterion for immunogenicity was met for all serotypes except 6B, 9V, and 3. The differences for serotypes 6B and 9V were marginal. One month after the fourth dose, the noninferiority criterion for immunogenicity was met for all serotypes except serotype 3​​​​​​​

• Prevnar 13® elicited functional antibody responses for all 13 serotypes following the third and fourth doses