title: Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine: an open-labeled, randomized trial in healthy Korean children.
abstract: OBJECTIVE
  This study (NCT00751348) evaluated the immunogenicity and safety of a combined measles-mumps-rubella-varicella (MMRV) vaccine compared to co-administration of measles-mumps-rubella and varicella (MMR+V) vaccines in Korean children during their second year of life.
  
  
  METHODS
  Healthy children aged 11-24 months received one dose of MMRV or MMR+V. Antibody titers against measles, mumps and rubella were measured using enzyme-linked immunosorbent assay and against varicella using an immunofluorescence assay. Parents/guardians recorded adverse events in diary cards for up to 43 days post-vaccination. The primary objective was to demonstrate non-inferiority of MMRV to MMR+V for all antigens in terms of seroconversion rates (SCRs), defined as a group difference with a lower limit of the 95% confidence interval (CI)>-10%.
  
  
  RESULTS
  Of 474 subjects enrolled, 458 (MMRV, 301; MMR+V, 157) were included in the according-to-protocol cohort. For measles (98.0% vs. 99.4%), rubella (99.7% vs. 100%) and varicella (98.9% vs. 100%) SCRs, the lower limits of the 95% CIs for group differences were greater than -10%; however, for mumps SCRs (88.8% vs. 94.2%), it was -10.40%. The primary objective of non-inferiority in mumps SCRs was therefore not met, although the observed group difference in a post-hoc analysis of anti-mumps antibodies using a plaque reduction neutralization assay was 0.39% with a 95% CI lower limit of -4.03%. Adverse events occurred at comparable frequencies for both groups, except for more frequent fever in MMRV recipients.
  
  
  CONCLUSIONS
  Based on the pre-specified non-inferiority criterion, SCRs of the MMRV vaccine were non-inferior to that elicited by MMR+V vaccines for all antigens except mumps.
authors.affiliation: Department of Pediatrics, Kyung Hee University Hospital, Kung Hee University School of Medicine, Seoul, Korea.
authors.forename: Sung-Ho
authors.initials: SH
authors.lastname: Cha
authors.affiliation: Department of Pediatrics, Hangang Sacred Heart Hospital, Hallym University Medical Center, Hallym University College of Medicine, Seoul, Korea.
authors.forename: Seon-Hee
authors.initials: SH
authors.lastname: Shin
authors.affiliation: Department of Pediatrics, CHA Bundang Medical Center, CHA University, Seongnam, Korea.
authors.forename: Taek-Jin
authors.initials: TJ
authors.lastname: Lee
authors.affiliation: Department of Pediatrics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea.
authors.forename: Chang Hwi
authors.initials: CH
authors.lastname: Kim
authors.affiliation: Department of Statistics, GlaxoSmithKline Biologicals, Wavre, Belgium.
authors.forename: Michael
authors.initials: M
authors.lastname: Povey
authors.affiliation: Department of Pediatrics, Yonsei University Wonju College of Medicine, Wonju, Korea.
authors.forename: Hwang Min
authors.initials: HM
authors.lastname: Kim
authors.affiliation: Clinical Development, MMR/V Vaccines, Global Vaccines Development, GlaxoSmithKline Biologicals-Philadelphia, King of Prussia, PA, USA.
authors.forename: Ouzama
authors.initials: O
authors.lastname: Nicholson
keywords: Immunogenicity; Korea; Measles-mumps-rubella-varicella vaccine; Plaque reduction assay; Safety