Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age

Summary

The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine. The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.

Timeline

Start

2009-06-03

Primary completion

2010-07-21

Completion

2012-06-18

Publications

• Background Mufson MA, Diaz C, Leonardi M, Harrison CJ, Grogg S, Carbayo A, Carlo-Torres S, JeanFreau R, Quintero-Del-Rio A, Bautista G, Povey M, Da Costa C, Nicholson O, Innis BL. Safety and Immunogenicity of Human Serum Albumin-Free MMR Vaccine in US Children Aged 12-15 Months. J Pediatric Infect Dis Soc. 2015 Dec;4(4):339-48. doi: 10.1093/jpids/piu081. Epub 2014 Aug 7.
• Berry AA, Abu-Elyazeed R, Diaz-Perez C, Mufson MA, Harrison CJ, Leonardi M, Twiggs JD, Peltier C, Grogg S, Carbayo A, Shapiro S, Povey M, Baccarini C, Innis BL, Henry O. Two-year antibody persistence in children vaccinated at 12-15 months with a measles-mumps-rubella virus vaccine without human serum albumin. Hum Vaccin Immunother. 2017 Jul 3;13(7):1516-1522. doi: 10.1080/21645515.2017.1309486. Epub 2017 May 8.

Drugs

Indications