title: Evaluation of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children.
abstract: BACKGROUND
  A quadrivalent measles, mumps, rubella and varicella vaccine would facilitate universal immunization against all 4 diseases, improve compliance and immunization rates and decrease the number of injections given to children and visits to physicians' offices.
  
  
  OBJECTIVE
  To evaluate 1- and 2-dose regimens of a combined measles, mumps, rubella and varicella vaccine (ProQuad, referred to as MMRV) manufactured with a varicella component of increased potency.
  
  
  METHODS
  In this partially blind, multicenter study, 480 healthy 12- to 23-month-old children were randomized to receive either MMRV and placebo or M-M-RII and VARIVAX. Injections were given concomitantly at separate sites. Subjects randomized to receive MMRV and placebo received a second dose of MMRV 90 days later. Subjects were followed for 42 days after each vaccination for adverse experiences. Immunogenicity was evaluated 6 weeks after each vaccination.
  
  
  RESULTS
  Measles-like rash and fever during days 5-12 were more common after the first dose of MMRV (rash, 5.9%; fever, 27.7%) than after M-M-RII and VARIVAX (rash, 1.9%; fever, 18.7%). The incidence of other adverse events were similar between groups. Response rates were >90% to all vaccine components in both groups. Geometric mean titers to measles and mumps were significantly higher after 1 dose of MMRV than after administration of M-M-RII and VARIVAX. The second dose of MMRV elicited slight to moderate increases in measles, mumps and rubella antibody titers and a substantial increase in varicella antibody titer (from 13.0 to 588.1 glycoprotein antigen-based enzyme-linked immunosorbent assay units/mL).
  
  
  CONCLUSIONS
  A 1- or 2-dose regimen of MMRV is generally well-tolerated when administered to 12- to 23-month-old children and has a safety and immunogenicity profile similar to that of M-M-RII and VARIVAX administered concomitantly.
authors.affiliation: The University of California San Francisco, USA.
authors.forename: Henry
authors.initials: H
authors.lastname: Shinefield
authors.forename: Steve
authors.initials: S
authors.lastname: Black
authors.forename: Laura
authors.initials: L
authors.lastname: Digilio
authors.forename: Keith
authors.initials: K
authors.lastname: Reisinger
authors.forename: Mark
authors.initials: M
authors.lastname: Blatter
authors.forename: Jacqueline O
authors.initials: JO
authors.lastname: Gress
authors.forename: Michelle L Hoffman
authors.initials: ML
authors.lastname: Brown
authors.forename: Karen A
authors.initials: KA
authors.lastname: Eves
authors.forename: Stephanie Olsen
authors.initials: SO
authors.lastname: Klopfer
authors.forename: Florian
authors.initials: F
authors.lastname: Schödel
authors.forename: Barbara J
authors.initials: BJ
authors.lastname: Kuter
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D019433:Chickenpox Vaccine / Q000008:administration & dosage* / Q000276:immunology; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D022542:Measles-Mumps-Rubella Vaccine / Q000008:administration & dosage* / Q000276:immunology; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D022542:Measles-Mumps-Rubella Vaccine; D017778:Vaccines, Combined; C050102:measles, mumps, rubella, varicella vaccine