NCT02058563

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

Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Seven Years and Older (209762)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 996 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will evaluate the immunogenicity of GSK's trivalent MMR vaccine (referred to as INV\_MMR vaccine) in contrast to the US standard of care (M-M-R®II, Merck and Company, referred to as COM\_MMR) when both are used as a second dose in subjects 7 years of age and older. In this study, the INV\_MMR vaccine may be administered as a second dose to persons with either a history or formal documentation of at least one dose immunization with any MMR vaccine. This study is intended to support licensure of GSK's MMR vaccine in the US.

Conditions

• Rubella
• Mumps
• Measles

Interventions

Type	Name	Description
BIOLOGICAL	Priorix®	1 dose administered as a subcutaneous (SC) injection.
BIOLOGICAL	Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine	1 dose administered subcutaneously.

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-05-24
• Completion: 2015-09-17
• First posted: 2014-02-10
• Last updated: 2018-06-06
• Results posted: 2017-04-10

Locations

17 sites across 3 countries: United States, Estonia, Slovakia