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

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).

► DTaP5-IPV-Hib and DTaP3-HBV-IPV/Hib were compared as 4th dose boosters in toddlers. ► Both DTaP5-IPV-Hib and DTaP3-HBV-IPV/Hib were coadministered with PCV7. ► Fever rates of DTaP5-IPV-Hib were noninferior to DTaP3-HBV-IPV/Hib. ► DTaP5-IPV-Hib and DTaP3-HBV-IPV/Hib had similar safety and immunogenicity profiles. ► DTaP5-IPV-Hib can be used as a booster after a hexavalent vaccine primary series.