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Immunogenicity and Safety of Two Doses of Tetravalent Measles-Mumps-Rubella-Varicella Vaccine in Healthy Children

Knuf, Markus MD*; Habermehl, Pirmin MD*; Zepp, Fred MD*; Mannhardt, Wilma MD*; Kuttnig, Martin MD†; Muttonen, Pekka MD†; Prieler, Albrecht MD†; Maurer, Hartwig MD†; Bisanz, Helmtrud MD‡; Tornieporth, Nadia MD§; Descamps, Dominique MD§; Willems, Paul MD§

Pediatric Infectious Disease Journal: January 2006 - Volume 25 - Issue 1 - pp 12-18
Original Studies

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 acombined 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 ≥37.5°C or rectal temperature ≥38.0°C; grade 3, axillary temperature >39.0°C or rectal temperature >39.5°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.

From the *Childrens Hospital, Johannes Gutenberg-University Hospital, Mainz, Germany; †private physicians in Klagenfurt, Villach, Neufeld and Salzburg, Austria; ‡GlaxoSmithKline GmbH & Co. KG, Munich, Germany; and §GlaxoSmithKline Biologicals Rixensart, Belgium

Accepted for publication September 1, 2005.

Supported by GlaxoSmithKline Biologicals.

Address for reprints: Markus Knuf, MD, Johannes Gutenberg-University, Childrens Hospital, Lagenbeckstrasse 1, D-55101 Mainz, Germany. Fax 49-6131-176624; E-mail knuf@kinder.klinik.uni-mainz.de.

© 2006 Lippincott Williams & Wilkins, Inc.