Safety and immunogenicity of fully liquid DTaP5-IPV-Hib pediatric combination vaccine (Pediacel®) compared to DTaP3-HBV-IPV/Hib (Infanrix® Hexa) when coadministered with heptavalent pneumococcal conjugate vaccine (PCV7) as a booster at 11-18 months of age: a phase III, modified double-blind, randomized, controlled, multicenter study.

ABSTRACT

This study compared the safety and immunogenicity of DTaP5-IPV-Hib vaccine (followed by monovalent hepatitis B vaccine [HBV]) and DTaP3-HBV-IPV/Hib vaccines, both coadministered with PCV7, as a fourth-dose booster in toddlers 11-18 months who had a hexavalent vaccine primary series. The fever rate within 4 days of DTaP5-IPV-Hib was noninferior to DTaP3-HBV-IPV/Hib. DTaP5-IPV-Hib induced a marked immune response and had a similar safety and immunogenicity profile compared with DTaP3-HBV-IPV/Hib. Fully liquid DTaP5-IPV-Hib can be used as a booster after a hexavalent vaccine primary series; where required, a fourth dose of monovalent HBV can be administered after DTaP5-IPV-Hib (NCT ID NCT00355654).