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

Published

Journal Article

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 during 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 Hoemophilus influenzoe 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.

Full Text

Duke Authors

Cited Authors

  • Kuter, BJ; Brown, MLH; Hartzel, J; Williams, WR; EvesiKaren, A; Black, S; Shinefield, H; Reisinger, KS; Marchant, CD; Sullivan, BJ; Thear, M; Klopfer, S; Xu, J; Gress, JO; Schödel, F; Study Group for ProQuad,

Published Date

  • September 2006

Published In

Volume / Issue

  • 2 / 5

Start / End Page

  • 205 - 214

PubMed ID

  • 17035730

Pubmed Central ID

  • 17035730

International Standard Serial Number (ISSN)

  • 1554-8600

Digital Object Identifier (DOI)

  • 10.4161/hv.2.5.3246

Language

  • eng

Conference Location

  • United States