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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

Schuster, Volker MD*; Otto, Walter MD; Maurer, Lothar MD; Tcherepnine, Patricia MD; Pfletschinger, Ulrich MD; Kindler, Klaus MD; Soemantri, Peter MD; Walther, Uta MD; Macholdt, Ute MD; Douha, Martine MSc; Pierson, Patrice MSc; Willems, Paul MD

The Pediatric Infectious Disease Journal: August 2008 - Volume 27 - Issue 8 - p 724-730
doi: 10.1097/INF.0b013e318170bb22
Original Studies

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−1, respectively). Both vaccine regimens were generally well-tolerated in terms of local reactions, fever >39.5°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.

From the *Hospital for Children and Adolescents, University of Leipzig, Leipzig; †Pediatric offices in Fulda, Frankenthal, Roding, Stuttgart, Trier, Kleve-Materborn, Berlin, Neuhaus am Rennweg, Germany; and ‡GlaxoSmithKline Biologicals, Rixensart, Belgium.

Accepted for publication February 26, 2008.

The study was funded by GlaxoSmithKline Biologicals, which also provided assistance with study design and data acquisition.

U.P. has been investigator for GlaxoSmithKline, Chiron-Behring, MSD, und Aventis-Pasteur-Merieux in the past.

V.S. has been involved as investigator in several other vaccine studies sponsored by GlaxoSmithKline.

M.D., P.P., and P.W. are employees of GlaxoSmithKline Biologicals.

Address for correspondence: Prof. Volker Schuster, Hospital for Children and Adolescents, University of Leipzig, Liebigstrasse 20a, 04103 Leipzig, Germany. E-mail: volker.schuster@medizin.uni-leipzig.de.

© 2008 Lippincott Williams & Wilkins, Inc.