Immunogenicity and safety of combined measles-mumps-rubella-varicella vaccine
using new measles and rubella working seeds in healthy children in Taiwan and
Singapore: a phase II, randomized, double-blind trial.
Author(s): Huang LM(1), Lee BW, Chan PC, Povey M, Henry O.
Affiliation(s): Author information:
(1)Department of Pediatrics; National Taiwan University Hospital; Taipei, Taiwan.
Publication date & source: 2013, Hum Vaccin Immunother. , 9(6):1308-15
AIM: This study evaluated the immunogenicity and safety of tetravalent
measles-mumps-rubella-varicella (MMRV) vaccine produced with measles and rubella
monovalent bulks derived from a newly established working seed virus stock
(MMRV(new WS)) compared with the combined MMRV vaccine derived from the current
seed virus stock, in Taiwanese and Singaporean children (NCT00892775).
METHODS: Healthy children aged 11-22 mo were randomized to receive two doses of
either the MMRV(new WS) vaccine or the MMRV vaccine. Antibody titers against
measles, mumps and rubella were measured using ELISA and against varicella using
an immunofluorescence assay. The primary objective was to demonstrate
non-inferiority of MMRV(new WS) to MMRV in terms of post-dose-1 seroconversion
rates, defined as a group difference with a lower limit of the 95% confidence
interval greater than -10% for each antigen. Parents/guardians recorded symptoms
in diary cards for 43 d after each vaccine dose.
RESULTS: Non-inferiority of MMRV(new WS) to MMRV was achieved for all vaccine
antigens. The lower limits of the 95% confidence intervals for group differences
(MMRV(new WS) group vs. MMRV) for measles (99.4% vs 100%), mumps (89.7% vs
90.4%), rubella (99.7% vs 100%) and varicella (97.6% vs 92.9%) seroconversion
rates were greater than -10%. Mild symptoms including a peak in fever between
days 5 and 12, post-dose-1, was observed in both groups.
CONCLUSION: The immune responses elicited by the MMRV(new WS) vaccine were
non-inferior to that elicited by the MMRV vaccine for all antigens. Both vaccines
exhibited an acceptable safety profile in Taiwanese and Singaporean children.
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