Trials / Completed
CompletedNCT00861744
Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age
A Phase II, Randomized, Observer Blind, Controlled, Multicenter Study to Assess Immunogenicity and Antibody Persistence Following Vaccination With GSK's Candidate Combined Measles, Mumps, and Rubella Vaccine (MMR) Versus M-M-R® II as a First Dose, Both Administered Subcutaneously at 12-15 Months of Age, Concomitantly With Hepatitis A Vaccine (HAV), Varicella Vaccine (VV) and Pneumococcal Conjugate Vaccine (PCV) But at Separate Sites.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1,259 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 12 Months – 15 Months
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2009-06-03
- Primary completion
- 2010-07-21
- Completion
- 2012-06-18
- First posted
- 2009-03-13
- Last updated
- 2020-01-03
- Results posted
- 2011-11-04
Locations
48 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT00861744. Inclusion in this directory is not an endorsement.