Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
Condition: Tetanus; Diphtheria; Pertussis; Measles; Polio
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus; Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus; Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus; Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®); 0.5 mL, Intramuscular (IM) DAPTACEL®; Subcutaneous (SC) MMR®II and VARIVAX®; IM or SC IPOL®; 0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®); 0.5 mL, Intramuscular (IM) DAPTACEL®; Subcutaneous (SC) MMR®II and VARIVAX®; IM or SC IPOL®
Other intervention name(s): DTap-IPV; M-M-R®II; VARIVAX®; DAPTACEL®; IPOL®; M-M-M R®II; VARIVAX®; DTap-IPV; M-M-R®II; VARIVAX®; DAPTACEL®; IPOL®; M-M-R®II; VARIVAX®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tetanus; Diphtheria; Pertussis; DTap-IPV; DAPTACEL®; VARIVAX®