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

NCT01621802 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4011

Last updated 2019-11-25

Study results available
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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.

Conditions

  • Measles-Mumps-Rubella

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-21
Primary Completion
2015-07-06
Completion
2015-11-09
FDA Drug
Yes

Countries

  • United States
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01621802 on ClinicalTrials.gov