Immunogenicity and Safety of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Volunteers, Seven Years of Age and Older

Summary

The purpose of this study is to evaluate the immunogenicity and safety of GSK's trivalent MMR (Priorix®), comparing it to Merck"s MMR vaccine (M-M-R®II), which is approved for use in the US.

Timeline

Start

2014-07-01

Primary completion

2015-05-24

Completion

2015-09-17

Outcome

Met primary endpoint

paper non-inferiority compared to MMR II was demonstrated. PMID 29902133 ↗

paper The dose of MMR-RIT induced robust immune responses that were not inferior to those of MMR II, and was well tolerated. PMID 29902133 ↗

Publications

• Abu-Elyazeed R, Jennings W, Severance R, Noss M, Caplanusi A, Povey M, Henry O. Immunogenicity and safety of a second dose of a measles-mumps-rubella vaccine administered to healthy participants 7 years of age or older: A phase III, randomized study. Hum Vaccin Immunother. 2018;14(11):2624-2631. doi: 10.1080/21645515.2018.1489186. Epub 2018 Jul 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	M-M-R II	Vaccine	—	Subcutaneous
Subject	Priorix	Vaccine	—	Subcutaneous

Indications