Immunogenicity and safety of fully liquid DTaP5-IPV-Hib compared with DTaP3-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to 18 months of age: A phase III, single-blind, randomised, controlled, multicentre study

摘要

This study compared immunogenicity and safety of DTaP5-IPV-Hib to DTaP3-IPV/Hib coadministered with PCV7 at 2,3, and 4 months (primary series) and a fourth-dose booster at 12-18 months of age. Seroprotection rates for DTaP5-IPV-Hib were high (noninferior to DTaP3-IPV/Hib for the primary series) for antigens common to both vaccines and PCV7 antigens. Geometric mean concentration (GMC) for Hib antibodies were higher in the DTaP5-IPV-Hib group than the DTaP3-IPV/Hib group after the primary series and booster dose; GMCs or titers for other antigens were generally similar between groups after the primary series and booster dose. Safety profiles were similar between groups