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Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age

NCT02184572 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1742

Last updated 2021-01-07

Study results available
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Summary

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' trivalent MMR (Priorix), comparing it to Merck's MMR vaccine (M-M-R II), which is approved for use in the US in healthy children 12 to 15 months of age.

Conditions

  • Measles; Mumps; Rubella
  • Measles-Mumps-Rubella Vaccine

Interventions

BIOLOGICAL

Priorix

1 dose administered subcutaneously in the triceps region of left arm at Day 0

BIOLOGICAL

M-M-R II

1 dose administered subcutaneously in the triceps region of left arm at Day 0

BIOLOGICAL

Varivax

1 dose administered subcutaneously in the triceps region of right arm at Day 0

BIOLOGICAL

Havrix

1 dose administered intramuscularly in the anterolateral region of the right thigh at Day 0

BIOLOGICAL

Prevnar 13

1 dose administered intramuscularly in the anterolateral region of the left thigh at Day 0 to subjects recruited in US

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
15 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-25
Primary Completion
2015-08-14
Completion
2015-12-22

Countries

  • United States
  • Estonia
  • Finland
  • Puerto Rico
  • 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 NCT02184572 on ClinicalTrials.gov