COMPARATIVE STUDY
JOURNAL ARTICLE

Immunogenicity and safety of two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children

Markus Knuf, Pirmin Habermehl, Fred Zepp, Wilma Mannhardt, Martin Kuttnig, Pekka Muttonen, Albrecht Prieler, Hartwig Maurer, Helmtrud Bisanz, Nadia Tornieporth, Dominique Descamps, Paul Willems
Pediatric Infectious Disease Journal 2006, 25 (1): 12-8
16395096

BACKGROUND: Combination vaccines against common childhood diseases are widely used, provide an improved coverage, are more convenient and are more cost-effective than multiple injections. We conducted a study to evaluate the safety and immunogenicity of a combined measles-mumps-rubella-varicella (MMRV) candidate vaccine in comparison with the separate administration of licensed measles-mumps-rubella (MMR; Priorix) and varicella (V; Varilrix) vaccines.

METHODS: Healthy children 12-18 months of age received 2 doses of MMRV vaccine (3 lots) 6-8 weeks apart (MMRV group) or 1 dose of MMR vaccine administered concomitantly with 1 dose of varicella vaccine, followed by a second dose of MMR at 6-8 weeks later (MMR+V group). Local symptoms (redness, pain and swelling) were recorded for 4 days after vaccination, and fever (any, axillary temperature > or =37.5 degrees C or rectal temperature > or =38.0 degrees C; grade 3, axillary temperature >39.0 degrees C or rectal temperature >39.5 degrees C) was monitored daily for 15 days. Other adverse events were monitored for 6 weeks.

RESULTS: A total of 494 children were vaccinated (371 in the MMRV group and 123 in the MMR+V group. Two doses of MMRV vaccine were at least as immunogenic as 2 doses of MMR and 1 dose of varicella vaccine. After the second dose, all children had seroconverted to measles, rubella and varicella in both vaccine groups, and 98% versus 99% had seroconverted to mumps in the MMRV versus the MMR+V group, respectively. The MMRV vaccine did not induce an increased local or general reactogenicity compared with the separate administration, although a higher incidence of low grade fever was seen after the first dose in the MMRV group (67.7% after MMRV versus 48.8% after MMR+V; P < 0.05), this was not observed for grade 3 fever (11.6% after MMRV versus 10.6% after MMR+V; P = 0.87). After the second dose, no differences in incidence of fever were found in either MMRV or MMR+V groups.

CONCLUSION: Administration of 2 doses of the combined MMRV vaccine was as immunogenic and well-tolerated as separate injections of MMR and varicella vaccine.

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