NCT01621802

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age

Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Four to Six Years of Age (209762)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,011 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.

Detailed description

The GSK Biologicals' MMR vaccine (Priorix®) and Merck's MMR vaccine (M-M-R®II) are referred to as Inv\_MMR vaccine and Com\_MMR vaccine respectively. 2 lots of the comparator vaccine (Com\_MMR\_L1 and Com\_MMR\_L2) will be used, but the 2 lots will be analysed as a pool. The Inv\_MMR vaccine will be administered as a second dose to children who already received a first dose Com\_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or Varivax®), some children will receive one dose of these vaccines along with either of the MMR vaccines.

Conditions

• Measles-Mumps-Rubella

Interventions

Type	Name	Description
BIOLOGICAL	Priorix	One dose administered subcutaneously in the triceps region of the right arm.
BIOLOGICAL	M-M-R II	One dose administered subcutaneously in the triceps region of the right arm.
BIOLOGICAL	Kinrix	One dose administered by deep intramuscular injection in the upper left deltoid.
BIOLOGICAL	ProQuad	One dose administered subcutaneously in the triceps region of the left arm.

Timeline

• Start date: 2012-06-21
• Primary completion: 2015-07-06
• Completion: 2015-11-09
• First posted: 2012-06-18
• Last updated: 2019-11-25
• Results posted: 2017-09-13

Locations

67 sites across 3 countries: United States, South Korea, Taiwan

Regulatory

• FDA-regulated drug study