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Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM

NCT00969436 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2018-06-08

Study results available
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Summary

The purpose of this study is to assess non-inferiority of two different vaccination regimens using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix™ administered at 9 months of age followed by concomitant administration of Priorix™ with Varilrix™ at 15 months of age in a measles endemic environment such as India.

Conditions

Interventions

BIOLOGICAL

GSK Biological's investigational MMRV vaccine 208136

Subcutaneous injection

BIOLOGICAL

Priorix™

Subcutaneous injection

BIOLOGICAL

Varilrix™

Subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
10 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-09
Primary Completion
2011-02-21
Completion
2011-02-21

Countries

  • India

Study Locations

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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 NCT00969436 on ClinicalTrials.gov