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 journalArticle

19 Citations (Scopus)

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
JournalPediatric Infectious Disease Journal
Volume31
Issue number8
DOIs
StatePublished - Aug 2012
Externally publishedYes

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Hepatitis A Vaccines
Mumps virus
Rubella virus
Conjugate Vaccines
Pneumococcal Vaccines
Measles virus
Hepatitis
Vaccines
Measles-Mumps-Rubella Vaccine
Confidence Intervals
Safety
Human Herpesvirus 3
Enzyme-Linked Immunosorbent Assay
Antibodies
measles, mumps, rubella, varicella vaccine
Heptavalent Pneumococcal Conjugate Vaccine

All Science Journal Classification (ASJC) codes

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

Cite this

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

In: Pediatric Infectious Disease Journal, Vol. 31, No. 8, 08.2012.

Research output: Contribution to journalArticle

Blatter, MM, Klein, NP, Shepard, JS, Leonardi, M, Shapiro, S, Schear, M, Mufson, MA, Martin, JM, Varman, M, Grogg, S, London, A, Cambron, P, Douha, M, Nicholson, O, Da Costa, C & Innis, BL 2012, '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', Pediatric Infectious Disease Journal, vol. 31, no. 8. https://doi.org/10.1097/INF.0b013e318259fc8a
Blatter, Mark M. ; Klein, Nicola P. ; Shepard, Julie S. ; Leonardi, Michael ; Shapiro, Steven ; Schear, Martin ; Mufson, Maurice A. ; Martin, Judith M. ; Varman, Meera ; Grogg, Stanley ; London, Arnold ; Cambron, Pierre ; Douha, Martine ; Nicholson, Ouzama ; Da Costa, Christopher ; Innis, Bruce L. / 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. In: Pediatric Infectious Disease Journal. 2012 ; Vol. 31, No. 8.
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title = "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",
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",
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AU - Blatter, Mark M.

AU - Klein, Nicola P.

AU - Shepard, Julie S.

AU - Leonardi, Michael

AU - Shapiro, Steven

AU - Schear, Martin

AU - Mufson, Maurice A.

AU - Martin, Judith M.

AU - Varman, Meera

AU - Grogg, Stanley

AU - London, Arnold

AU - Cambron, Pierre

AU - Douha, Martine

AU - Nicholson, Ouzama

AU - Da Costa, Christopher

AU - Innis, Bruce L.

PY - 2012/8

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N2 - 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

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