Published online May 14, 2007
PEDIATRICS Vol. 119 No. 6 June 2007, pp. e1299-e1305 (doi:10.1542/10.1542/peds.2006-2283)

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ARTICLE

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, DO^a, Karen Eves, BS^b, Kristy Campbell, MS^b, Steven B. Black, MD^c, Jerry D. Twiggs, MD^d, Keith S. Reisinger, MD^e, Ralph M. Conti, MD^f, Carl-Erik Flodmark, MD^g, Lars Rombo, MD^h, Stephanie Klopfer, PhD^b, Florian Schödel, MD^b, Jonathan Hartzel, PhD^b, Barbara J. Kuter, PhD, MPH^b and the Refrigerator-Stable Formulation Study Group for ProQuad

^a Dartmouth Medical School, Children's Hospital at Dartmouth, Lebanon, New Hampshire
^b Merck Research Laboratories, West Point, Pennsylvania
^c Kaiser Permanente Vaccine Study Center, Oakland, California
^d Dixie Pediatrics, St George, Utah
^e Primary Physicians Research, Pittsburgh, Pennsylvania
^f Foothills Pediatrics, Henderson, Nevada
^g Department of Pediatrics, University Hospital, Universitetssjukhuset MAS, Malmö, Sweden
^h Department of Infectious Diseases, Malarsjukhuset, Eskiltuna, Sweden

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.

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Key Words: measles • mumps • rubella • varicella • vaccine • ProQuad • Varivax • M-M-RII • immunization

Abbreviations: VRC—vaccination report card • VZV—varicella zoster virus • ELISA—enzyme-linked immunosorbent assay • gpELISA—glycoprotein antigen–based enzyme-linked immunosorbent assay • GMT—geometric mean titer • CI—confidence interval

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Accepted Nov 21, 2006.

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