The Phase 3 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.
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.
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.
The Pediatric Infectious Disease Journal published results of this clinical trial in March 2017.
Results: Noninferiority of DTaP5-IPV compared with DTaP5+IPV for all antigens was achieved. Booster rate differences were 5.4% for pertussis toxoid (PT); 7.4% for filamentous hemagglutinin; 3.7% for pertactin (PRN); 4.8% for fimbriae types 2 and 3; -0.1% for tetanus; -1.9% for diphtheria; 3.7% for poliovirus 1; -0.7% for poliovirus 2 and 0.3% for poliovirus 3. GMC ratios were 1.97 for PT; 1.56 for filamentous hemagglutinin; 1.51 for PRN; 1.33 for fimbriae types 2 and 3; 1.17 for tetanus; 1.20 for diphtheria; 1.27 for poliovirus 1; 0.90 for poliovirus 2 and 1.34 for poliovirus 3.
Rates of immediate and unsolicited adverse events solicited injection site reactions and systemic reactions were similar between groups.
Conclusions: DTaP5-IPV was safe and immunogenic in children 4-6 years of age.