Dataset from A Phase 3, Randomized, Active-controlled, Double-blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine Given With Dtap Compared To Open-label Dtap In Healthy Japanese Infants

Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group
1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular
pertussis vaccine (DTaP), Group 2: 7-valent pneumococcal conjugate vaccine (7vPnC) and DTaP,
Group 3: DTaP alone. Group 3 subjects will also receive catch-up doses of Prevenar
(commercial product of Prevenar in Japan) 13vPnC and 7vPnC will be blinded, and DTaP will be
open-label. The main purpose of the study is to determine if the immune responses to 13vPnC
are comparable to the immune responses to 7vPnC and if the immune responses to 13vPnC given
with DTaP are comparable to those induced by DTaP given alone. In addition, the study aims to
evaluate the side effects (safety profile) after vaccination of 13vPnC and 7vPnC when given
with DTaP in healthy Japanese infants.