Comparison of the safety and immunogenicity of a refrigerator-stable versus a frozen formulation of proquad (measles, mumps, rubella, and varicella virus vaccine live)

Henry H. Bernstein, Karen Eves, Kristy Campbell, Steven B. Black, Jerry D. Twiggs, Keith S. Reisinger, Ralph M. Conti, Carl Erik Flodmark, Lars Rombo, Stephanie Klopfer, Florian Schödel, Jonathan Hartzel, Barbara J. Kuter, Wilson P. Andrews, Jerry C. Bernstein, Joseph Bertino, Stanley L. Block, Louis Brine, Kevin Browngoehl, Matthew CoxRobert Dracker, Michael Gerber, Gregory C. Gray, J. Randy Hedgepeth, Harry Keyserling, Paul Lei, Michael Levin, Carl Lindgren, Stephen Luber, Edgardo Malacaman, Colin Marchant, Michelle Ogle, Shelly D. Senders, Julie Shepard, Douglas Short, Malcolm Sperling, Robert Stacks, James Troutman

Research output: Contribution to journalArticle

10 Scopus citations

Abstract

OBJECTIVE. A refrigerator-stable formulation of ProQuad has been developed to expand the utility of ProQuad to areas in which maintenance of a frozen cold chain (-15°C or colder) during storage and transport may not be feasible. The objective of this study was to demonstrate that the immunogenicity and safety profiles of a refrigerator-stable formulation of ProQuad are similar to the recently licensed frozen formulation. METHODS. In this double-blind, randomized, multicenter study, healthy 12- to 23-month-old children with negative vaccination and clinical histories for measles, mumps, rubella, varicella, and zoster were vaccinated with either the refrigerator-stable formulation of ProQuad (N = 1006) or the frozen formulation of ProQuad (N = 513). Patients were followed for 42 days after vaccination for adverse experiences. Immunogenicity was evaluated 6 weeks after vaccination. RESULTS. The refrigerator-stable formulation of ProQuad was generally well tolerated. The incidence of adverse experiences was similar between groups. No vaccine-related serious adverse experiences were reported. For both groups, the response rate was ≥97.7% for measles, mumps, and rubella, and the percentage of patients with a varicella zoster virus antibody titer of ≥5 U/mL glycoprotein antigen-based enzyme-linked immunosorbent assay after vaccination was ≥88.8%. The geometric mean titers for all antigens were numerically slightly higher in patients who received the refrigerator-stable formulation. CONCLUSIONS. The refrigerator-stable formulation of ProQuad is generally well tolerated, highly immunogenic, and noninferior in terms of postvaccination antibody responses. This refrigerator-stable formulation may improve ease of vaccine administration, increase use of the vaccine throughout the world because of its improved storage conditions, and replace the frozen formulation of ProQuad or any dose of M-M-RII and Varivax in routine practice.

Original languageEnglish (US)
Pages (from-to)e1299-e1305
JournalPediatrics
Volume119
Issue number6
DOIs
StatePublished - Jun 1 2007

Keywords

  • Immunization
  • M-M-RII
  • Measles
  • Mumps
  • ProQuad
  • Rubella
  • Vaccine
  • Varicella
  • Varivax

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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    Bernstein, H. H., Eves, K., Campbell, K., Black, S. B., Twiggs, J. D., Reisinger, K. S., Conti, R. M., Flodmark, C. E., Rombo, L., Klopfer, S., Schödel, F., Hartzel, J., Kuter, B. J., Andrews, W. P., Bernstein, J. C., Bertino, J., Block, S. L., Brine, L., Browngoehl, K., ... Troutman, J. (2007). Comparison of the safety and immunogenicity of a refrigerator-stable versus a frozen formulation of proquad (measles, mumps, rubella, and varicella virus vaccine live). Pediatrics, 119(6), e1299-e1305. https://doi.org/10.1542/peds.2006-2283