Safety and immunogenicity of a pentavalent vaccine compared with separate administration of licensed equivalent vaccines in US infants and toddlers and persistence of antibodies before a preschool booster dose: A randomized, clinical trial

Fernando A. Guerra, Mark M. Blatter, David P. Greenberg, Michael Pichichero, Fernando R. Noriega

Research output: Contribution to journalArticlepeer-review

39 Scopus citations

Abstract

OBJECTIVE. Our goal was to compare the safety and immunogenicity of a combination vaccine (DTaP 5-IPV-Hib;Pentacel) with that of its separately administered, US-licensed equivalent vaccines (diphtheria, tetanus, 5-component acellular pertussis vaccine [DTaP 5; Daptacel], inactivated poliovirus vaccine [IPV;IPOL], and Haemophilus influenzae type b [Hib] vaccine [ActHIB]), when administered to infants and toddlers concomitantly with other routinely recommended vaccines and to assess antibody persistence from the fourth dose in toddlers to the fifth (preschool) DTaP 5 dose. SUBJECTS AND METHODS.In this randomized, multicenter study, 1939 healthy infants were immunized at 2, 4, and 6 months of age with 1 of 3 lots of DTaP 5 coadministered with IPV and Hib vaccines or 1 lot of DTaP 5-IPV-Hib combination vaccine. Subsequently, 849 of these study participants were given a fourth dose of DTaP 5 and Hib vaccines or a fourth dose of DTaP 5-IPV-Hib at 1 to 16 months of age. Safety was monitored throughout the study, and blood specimens were obtained to assess antibody responses. RESULTS. DTaP 5-IPV-Hib elicited similar or fewer solicited injection-site and systemic reactions as compared with the separate administration of US-licensed DTaP 5, IPV, and Hib vaccines. Seroresponse and seroprotection rates elicited by DTaP 5-IPV-Hib were noninferior to US-licensed equivalent vaccines after the infant series and after the fourth dose. Children immunized with DTaP 5-IPV-Hib had higher antibody geometric mean concentrations to pertussis toxoid and filamentous hemagglutinin; children immunized with the separate vaccines had higher responses to pertactin. Hib antibody responses to Hib polysaccharide were nearly identical in the DTaP 5-IPV-Hib and separate-vaccine groups. Persistence of antibodies to the fifth (preschool) dose was also similar between groups. CONCLUSIONS. DTaP 5-IPV-Hib combination vaccine was shown to be immunogenic and well tolerated. No clinically important differences in the safety or immunologic profiles were noted for DTaP 5-IPV-Hib versus the separately administered, US-licensed equivalent vaccines. DTaP 5-IPV-Hib is a suitable replacement for separately administered DTaP, IPV, and Hib vaccines.

Original languageEnglish
Pages (from-to)301-312
Number of pages12
JournalPediatrics
Volume123
Issue number1
DOIs
StatePublished - 1 Jan 2009
Externally publishedYes

Keywords

  • Diphtheria-tetanus-acellular pertussis vaccines
  • Haemophilus influenzae vaccines
  • Poliovirus vaccine inactivated
  • Vaccines combined

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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