Immunogenicity and Safety of Two Tetravalent (Measles, Mumps, Rubella, Varicella) Vaccines Coadministered with Hepatitis A and Pneumococcal Conjugate Vaccines to Children Twelve to Fourteen Months of Age

Mark M. Blatter, Nicola P. Klein, Julie S. Shepard, Michael Leonardi, Steven Shapiro, Martin Schear, Maurice A. Mufson, Judith M. Martin, Meera Varman, Stanley Grogg, Arnold London, Pierre Cambron, Martine Douha, Ouzama Nicholson, Christopher da Costa, Bruce L. Innis

Research output: Contribution to journalArticlepeer-review

19 Scopus citations

Abstract

Background: This study compared single-dose tetravalent measles, mumps, rubella, varicella vaccine, Priorix-Tetra, stored refrigerated (GSK+4C) or frozen (GSK-20C), with ProQuad (Merck-20C), when coadministered with hepatitis A vaccine (HAV) and 7-valent pneumococcal conjugate vaccine (PCV7). Methods: Multicenter, observer-blind phase 2 study in 1783 healthy 12-14 month olds randomized to: GSK+4C (n = 705), GSK-20C (n = 689) or Merck-20C (n = 389), administered concomitantly with HAV (Havrix) and PCV7 (Prevnar). Seroresponse rates and antibody geometric mean concentrations/titers were determined from enzyme-linked immunosorbent assay and neutralization assays. Reactogenicity and safety were assessed. Results: Seroresponse rates (day 42) were >97% for measles and rubella viruses and >92% for mumps virus, in all groups. Noninferiority of both GSK+4C and GSK-20C vaccines versus Merck-20C was demonstrated for seroresponse rates to measles, mumps and rubella viruses (lower 97.5% confidence interval above-5%,-10% and-5%, respectively). For varicella-zoster virus, seroresponse rates were 57.1%, 69.8% and 86.7% in the GSK+4C, GSK-20C and Merck-20C groups, respectively. Noninferiority was not shown for either GSK vaccine (lower 97.5% confidence intervals

Original languageEnglish (US)
Pages (from-to)e133-e140
JournalPediatric Infectious Disease Journal
Volume31
Issue number8
DOIs
StatePublished - Aug 2012
Externally publishedYes

All Science Journal Classification (ASJC) codes

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

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