JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life

Volker Schuster, Walter Otto, Lothar Maurer, Patricia Tcherepnine, Ulrich Pfletschinger, Klaus Kindler, Peter Soemantri, Uta Walther, Ute Macholdt, Martine Douha, Patrice Pierson, Paul Willems
Pediatric Infectious Disease Journal 2008, 27 (8): 724-30
18600190

BACKGROUND: Measles, mumps, and rubella (MMR) and varicella (V) vaccines are often coadministered at 1 clinic visit. This study (104389/NCT00127023) was undertaken to assess the immunogenicity and safety of a new refrigerator-stable tetravalent MMRV vaccine after 1 dose and after 2 doses administered during the second year of life.

METHODS: Nine hundred seventy healthy children aged 10-21 months received 2 doses of MMRV vaccine (Priorix-Tetra; GlaxoSmithKline Biologicals, Rixensart, Belgium) 42 days apart (MMRV group; N = 732) or 1 dose of MMR vaccine (Priorix) coadministered with varicella vaccine (Varilrix) followed by a second dose of only MMR vaccine 42 days later (MMR + V group; N = 238).

RESULTS: Observed seroconversion rates for measles, mumps, rubella, and varicella antibodies 42 days postdose 1 were 94.5%, 96.1%, 99.7%, 95.5% in the MMRV group and 93.4%, 93.6%, 98.1%, 95.6% in the MMR + V group. Respective seroconversion rates postdose 2 were 98.3%, 99.4%, 99.7%, 99.7% in the MMRV group and 97.6%, 99.5%, 100%, 97.5% in the MMR + V group. Observed antimeasles and antimumps geometric mean titers (GMTs) were higher after each dose in the MMRV group than in the MMR + V group. Antivaricella GMT increased 21-fold in the MMRV group postdose 2, and was markedly higher than in the MMR + V group who did not receive a second dose of varicella (1903.3 and 80.3 dilution, respectively). Both vaccine regimens were generally well-tolerated in terms of local reactions, fever >39.5 degrees C, and vaccine-related rashes.

CONCLUSIONS: Both after 1 dose and after 2 doses, the MMRV vaccine was at least as immunogenic as concomitant MMR and varicella vaccination suggesting that it could be suitable for use according to current vaccination schedules.

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