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Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age

NCT00861744 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1259

Last updated 2020-01-03

Study results available
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Summary

The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine.

The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.

Conditions

Interventions

BIOLOGICAL

GSK Biological's investigational vaccine 209762

Subcutaneous injection, one dose

BIOLOGICAL

M-M-R® II (Merck and Co)

Subcutaneous injection, one dose

BIOLOGICAL

Varivax®

Subcutaneous injection, one dose

BIOLOGICAL

Havrix®

Intramuscular injection, one dose

BIOLOGICAL

Prevnar®

Intramuscular injection, one dose

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
2009-06-03
Primary Completion
2010-07-21
Completion
2012-06-18

Countries

  • United States
  • Puerto Rico

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 NCT00861744 on ClinicalTrials.gov