The overall aim of the Phase 3 study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.
Vaccine published the results of this study in May 2012.
Results: Antibody responses and geometric mean concentrations/geometric mean titers (GMCs/GMTs) elicited by each combination vaccine were noninferior (upper-bound 90% confidence interval of GMC/GMT ratios <1.5) to control vaccines except pertactin GMCs were higher after 4 control DTaP doses (157.46 EU/mL) than after Dose 4 with DTaP and Hib (after a PENTA infant series) (111.70 EU/mL) and after 4 PENTA doses (98.00 EU/mL). Fever rates in the combination vaccine groups were noninferior (upper bound 95% CI of combination vaccine group fever rate minus control vaccine group fever rate <10%) to the control vaccine group except the rate after 4 QUAD and Hib doses (23.5%) was higher than after 4 control DTaP doses (13.9%).
Conclusions: PENTA and QUAD had similar safety profiles and no clinically important differences in immunogenicity compared with separately administered control vaccines.