Lot-to-Lot Consistency, Safety, Tolerability, and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants

Stanley L. Block, Nicola P. Klein, Kwabena Sarpong, Stephen Russell, John Fling, Maria Petrecz, Sheryl Flores, Jin Xu, Guanghan Liu, Jon E. Stek, Ginamarie Foglia, Andrew W. Lee

Research output: Contribution to journalArticle

5 Scopus citations


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.

Original languageEnglish (US)
JournalPediatric Infectious Disease Journal
StateAccepted/In press - Nov 11 2016


ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)
  • Infectious Diseases

Cite this

Block, S. L., Klein, N. P., Sarpong, K., Russell, S., Fling, J., Petrecz, M., Flores, S., Xu, J., Liu, G., Stek, J. E., Foglia, G., & Lee, A. W. (Accepted/In press). Lot-to-Lot Consistency, Safety, Tolerability, and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants. Pediatric Infectious Disease Journal. https://doi.org/10.1097/INF.0000000000001405