Dataset from Safety and Immunogenicity of DTap-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined With Inactivated Poliovirus Vaccine) Compared to DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) + IPOL® (Poliovirus Vaccine Inactivated) as the 5th Dose in Children 4 to 6 Years of Age

The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® +
IPOL® as the 5th dose booster in children ≥ 4 to < 7 years of age in the US and Puerto Rico
who were previously vaccinated with DAPTACEL® and/or Pentacel® vaccines only.

Primary Objectives:

- To compare the pertussis [Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA),
Pertactin (PRN), and Fimbriae Types 2 and 3 (FIM)] booster responses and geometric mean
concentrations (GMCs) (as measured by enzyme-linked immunosorbent assay [ELISA])
following DTap-IPV vaccination to those elicited following DAPTACEL® + IPOL® vaccination
when administered as a 5th dose.

- To compare the diphtheria and tetanus booster responses and GMCs (as measured by ELISA)
following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL®
vaccinations when administered as a 5th dose .

- To compare the Inactivated Poliovirus Vaccine booster responses (as measured by
neutralizing assay) following DTap-IPV vaccination with those elicited following
DAPTACEL® + IPOL® vaccinations.

Observational Objectives:

- To compare the polio (types 1, 2, and 3) geometric mean titers (GMTs) following DTap-IPV
vaccination with those elicited following DAPTACEL® + IPOL® vaccinations.

- To assess the safety of DTap-IPV vaccine or DAPTACEL® + IPOL® vaccine when administered
as the fifth dose booster vaccine in participants previously vaccinated with DAPTACEL
and/or Pentacel vaccines.