Evaluate Vaccine Against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox

Summary

An observer-blind study to evaluate GlaxoSmithKline Biologicals' live attenuated varicella vaccine and GlaxoSmithKline Biologicals' combined measles-mumps-rubella-varicella vaccine in the prevention of varicella disease in children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Timeline

Start

2005-09-01

Primary completion

2006-10-12

Completion

2006-10-12

Publications

• Background Henry O, Brzostek J, Czajka H, Leviniene G, Reshetko O, Gasparini R, Pazdiora P, Plesca D, Desole MG, Kevalas R, Gabutti G, Povey M, Innis B. One or two doses of live varicella virus-containing vaccines: Efficacy, persistence of immune responses, and safety six years after administration in healthy children during their second year of life. Vaccine. 2018 Jan 8;36(3):381-387. doi: 10.1016/j.vaccine.2017.11.081. Epub 2017 Dec 7.
• Background Prymula R, Bergsaker MR, Esposito S, Gothefors L, Man S, Snegova N, Stefkovicova M, Usonis V, Wysocki J, Douha M, Vassilev V, Nicholson O, Innis BL, Willems P. Protection against varicella with two doses of combined measles-mumps-rubella-varicella vaccine versus one dose of monovalent varicella vaccine: a multicentre, observer-blind, randomised, controlled trial. Lancet. 2014 Apr 12;383(9925):1313-1324. doi: 10.1016/S0140-6736(12)61461-5. Epub 2014 Jan 29.
• Background Carryn S, Feyssaguet M, Povey M, Di Paolo E. Long-term immunogenicity of measles, mumps and rubella-containing vaccines in healthy young children: A 10-year follow-up. Vaccine. 2019 Aug 23;37(36):5323-5331. doi: 10.1016/j.vaccine.2019.07.049. Epub 2019 Jul 22.
• Habib MA, Prymula R, Carryn S, Esposito S, Henry O, Ravault S, Usonis V, Wysocki J, Gillard P, Povey M. Correlation of protection against varicella in a randomized Phase III varicella-containing vaccine efficacy trial in healthy infants. Vaccine. 2021 Jun 8;39(25):3445-3454. doi: 10.1016/j.vaccine.2021.02.074. Epub 2021 Mar 16.
• Povey M, Henry O, Riise Bergsaker MA, Chlibek R, Esposito S, Flodmark CE, Gothefors L, Man S, Silfverdal SA, Stefkovicova M, Usonis V, Wysocki J, Gillard P, Prymula R. Protection against varicella with two doses of combined measles-mumps-rubella-varicella vaccine or one dose of monovalent varicella vaccine: 10-year follow-up of a phase 3 multicentre, observer-blind, randomised, controlled trial. Lancet Infect Dis. 2019 Mar;19(3):287-297. doi: 10.1016/S1473-3099(18)30716-3. Epub 2019 Feb 11.

Drugs

Indications