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

Hum Vaccin. Sep-Oct 2006;2(5):205-14. doi: 10.4161/hv.2.5.3246.

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 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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Viral / blood
  • Chickenpox Vaccine / adverse effects*
  • Chickenpox Vaccine / immunology
  • Child
  • Child, Preschool
  • Enzyme-Linked Immunosorbent Assay
  • Humans
  • Infant
  • Logistic Models
  • Measles Vaccine / adverse effects*
  • Measles Vaccine / immunology
  • Mumps Vaccine / adverse effects*
  • Mumps Vaccine / immunology
  • Randomized Controlled Trials as Topic
  • Rubella Vaccine / adverse effects*
  • Rubella Vaccine / immunology
  • Vaccines, Combined / adverse effects
  • Vaccines, Combined / immunology

Substances

  • Antibodies, Viral
  • Chickenpox Vaccine
  • Measles Vaccine
  • Mumps Vaccine
  • Rubella Vaccine
  • Vaccines, Combined