MedTrace Logo

Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age

NCT01702428 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5016

Last updated 2019-11-25

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate consistency in terms of the immune response to three different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies, and compare its immunogenicity to Merck \& Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).

Conditions

Interventions

BIOLOGICAL

Priorix

Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.

BIOLOGICAL

M-M-R II

Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.

BIOLOGICAL

Varivax

Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.

BIOLOGICAL

Havrix

Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.

BIOLOGICAL

Prevnar 13

US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-11-09
Primary Completion
2014-11-25
Completion
2015-04-16
FDA Drug
Yes

Countries

  • United States
  • Estonia
  • Finland
  • Mexico
  • Puerto Rico
  • Spain

Study Locations

More Related Trials

Entities

Diseases
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 NCT01702428 on ClinicalTrials.gov