Safety and immunogenicity of a combination measles, mumps, rubella and varicella vaccine (ProQuad®)

Barbara J. Kuter*, Michelle L Hoffman Brown, Jonathan Hartzel, Wendy R. Williams, Karen A. Eves, Steve Black, Henry Shinefield, Keith S. Reisinger, Colin D. Marchant, Bradley J. Sullivan, Marci Thear, Stephanie Klopfer, Jin Xu, Jacqueline O. Gress, Florian Schödel, Brian K. Allen, Justin C. Alvey, Edwin L. Anderson, Wilson P. Andrews, Basim AsmarParvin H. Azimi, Charles S. Ball, Stephen R. Barone, Henry Bernstein, Jerry C. Bernstein, Robert Bettis, Steven Black, Mark M. Blatter, Stan Block, Jeffrey L. Blumer, Frederick P. Boehm, Robert Brayden, Kenneth Bromberg, John L. Buttler, Archana Chatterjee, Ralph Conti, Daniel L. Coury, David E. Danhauer, Robert S. Daum, Penelope Dennehy, Marc Dionne, Buckley Eckert, Kathryn M. Edwards, Robert V. Ford, Stephen M. Fries, Mary C. Goessler, David P. Greenberg, Fernando A. Guerra, Juan Guerrero, Scott Halperin, Frederick W. Henderson, Richard Hornick, Louise K. Iwaishi, Candice E. Johnson, Ronald C. Jones, Robert Karasov, Barbara Law, Joseph Leader, Mark Lebel, Jay Leiberman, Martha Lepow, Stephen Luber, Colin Marchant, Gary S. Marshall, David O. Matson, H. Cody Meissner, Philip D. Milnes, William Moore, Sharon A. Nachman, Beth Nauert, Keith Perrin, Bernard Pollara, Mobeen H. Rathore, William C. Rees, Keith S. Reisinger, Margaret Rennels, Edward Rothstein, Raul Rudoy, Margaret Russell, Michael E. Ryan, Mark Sawyer, Shelly D. Senders, Steven A. Shapiro, Lawrence Sher, Henry Shinefield, Peter E. Silas, Malcolm J. Sperling, Tracy Stewart, Bradley Sullivan, James A. Taylor, Steven M. Thompson, James L. Troutman, Katherine F. Vaughn, Charmaine L. Venters, Emmanuel Walter, Barbara Watson, Alan Werzberger, J. Gary Wheeler, Karen R. Williams, Michael F. Yeiser, Ram Yogev

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

43 Scopus citations

Abstract

Background: A combination measles, mumps, rubella, and varicella vaccine (ProQuad®, Merck & Co., Inc, West Point, PA) was evaluated in five clinical trials. Use of ProQuad® would result in fewer injections for children and would facilitate universal immunization against all four diseases. Objective: To describe the combined results obtained from the studies conducted dur-ing the clinical development program for ProQuad®. Methods: A total of 5833 healthy children, 12-23 months of age, and 399 healthy children, 4-6 years of age, received 1 or 2 doses of ProQuad® in five controlled clinical trials. M-M-R®II and VARIVAX® were used as the control for most studies. Safety was evaluated for six weeks postvaccination and immunogenicity was assessed six weeks after each dose by a sensitive assay (ELISA or gpELISA). Results: A single dose of ProQuad® in 12- to 23-month-old children was shown to be as immunogenic as a single dose of M-M-R®II and VARIVAX® and was generally well tolerated. ProQuad® can be used concomitantly with other vaccines (hepatitis B and Haemophilus influenzae b). A higher rate of fever was reported after 1 dose of ProQuad® compared to M-M-R®II and VARIVAX®, but fever episodes were transient without long-term sequelae. Both a 2-dose regimen of ProQuad® in 12- to 23-month-olds and use of ProQuad® in place of M-M-R®II at 4-6 years were shown to be immunogenic and well tolerated. The incidence of adverse experiences following a second dose of ProQuad® was lower than that following the initial dose. Conclusions: A single dose of ProQuad® is as immunogenic as M-M-R®II and VARIVAX® and is well tolerated in a 1- or 2-dose schedule. ProQuad® should easily fit into the routine immunization schedule.

Original languageEnglish (US)
Pages (from-to)205-214
Number of pages10
JournalHuman vaccines
Volume2
Issue number5
DOIs
StatePublished - 2006

Keywords

  • Combination vaccines
  • Measles
  • Mumps
  • Rubella
  • Varicella

ASJC Scopus subject areas

  • Immunology
  • Pharmacology, Toxicology and Pharmaceutics(all)

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