BACKGROUND: This multicenter Phase III study (NCT01340937) evaluated the consistency of immune responses to 3 separate lots of DTaP5-IPV-Hib-HepB, an investigational hexavalent vaccine (HV). METHODS: Healthy infants were randomized (2:2:2:1) to receive HV or Pentacel (Control). Groups 1, 2, and 3 received HV at 2, 4, and 6 months, and Control at 15 months. Group 4 received Control at 2, 4, 6, and 15 months, plus Recombivax HB (HepB) at 2 and 6 months. Concomitant Prevnar 13 (PCV13) was given to all groups at 2, 4, 6, and 15 months; pentavalent rotavirus vaccine (RV5) was given to all groups at 2, 4, and 6 months.Blood specimens (3mL-to-5mL) were collected immediately prior to administration of Dose 1, Postdose 3, immediately before toddler dose, and after toddler dose. Adverse events were recorded after each vaccination. RESULTS: The 3 manufacturing lots of HV induced consistent antibody responses to all antigens. Immunogenicity of HV was non-inferior to control for all antibodies, except for pertussis filamentous hemagglutinin (FHA) geometric mean concentration (GMC) postdose 3, and pertussis pertactin (PRN) GMC after toddler dose. Postdose 3 immunogenicity of concomitantly administered PCV13 was generally similar (except for serotype 6B) when given with HV or control.Adverse events of HV were similar to control, except for a higher rate of fever ≥ 38.0°C (49.2% vs. 35.4%, estimated difference 13.7 % [8.4, 18.8]). CONCLUSION: HV demonstrated lot-to-lot manufacturing consistency; safety and immunogenicity were comparable with the licensed vaccines. HV provides a new combination vaccine option within the US 2,4,6 month vaccine series.
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
- Microbiology (medical)
- Infectious Diseases