Tetanus Clinical Trial
Official title:
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.
All participants will be randomized to receive either one dose each of DTap-IPV + Measles, Mumps, and Rubella Virus Vaccine Live (M-M-R®II) + VARIVAX® or one dose each of DAPTACEL® + IPOL® + M-M-R®II + VARIVAX® on Day 0. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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