Clin Exp Vaccine Res.  2014 Jan;3(1):91-99. 10.7774/cevr.2014.3.1.91.

Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine: an open-labeled, randomized trial in healthy Korean children

• Cha SH
• Shin SH
• Lee TJ
• Kim CH
• Povey M
• Kim HM
• Nicholson

• KMID: 2049099
• DOI: http://doi.org/10.7774/cevr.2014.3.1.91

Abstract

PURPOSE
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.
MATERIALS AND 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.
CONCLUSION
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.

Keyword

Immunogenicity; Safety; Plaque reduction assay; Measles-mumps-rubella-varicella vaccine; Korea

MeSH Terms

Antibodies
Chickenpox
Child*
Cohort Studies
Enzyme-Linked Immunosorbent Assay
Fever
Fluorescent Antibody Technique
Humans
Korea
Measles
Mumps
Rubella
Vaccines
Antibodies
Vaccines

Figure

• 

  Fig. 1 Study profile. MMRV, measles-mumps-rubella-varicella; MMR+V, measles-mumps-rubella and varicella vaccines administered concomitantly; ATP, according-to-protocol.

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  Fig. 2 Reverse cumulative curve of anti-mumps antibody concentrations (ATP cohort). MMR+V, measles-mumps-rubella and varicella vaccines administered concomitantly; MMRV, measles-mumps-rubella-varicella; ATP, according-to-protocol.

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  Fig. 3 Prevalence of fever (any intensity) during the follow-up period (day 0-42). MMR+V, measles-mumps-rubella and varicella vaccines administered concomitantly; MMRV, measles-mumps-rubella-varicella.

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