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NCT00861744 · ClinicalTrials.gov registry record · Phase 2
Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age
A Phase 2 study of Measles and Mumps, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,259
- Enrollment target
- 20
- Study locations
NCT00861744: Completed Phase 2 study of Measles and Mumps, sponsored by GlaxoSmithKline.
NCT00861744 is a Phase 2 study of Measles and Mumps that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,259 participants, below the 2,421-participant average among 4 other Measles trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00861744, a Phase 2 study of Measles and Mumps, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,259 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations \<150 mIU/mL prior to vaccination.
Conditions Studied
Interventions
- BIOLOGICAL GSK Biological's investigational vaccine 209762
- BIOLOGICAL M-M-R® II (Merck and Co)
- BIOLOGICAL Varivax®
- BIOLOGICAL Havrix®
- BIOLOGICAL Prevnar®
Study Locations (20)
California
- GSK Investigational Site - Anaheim
- GSK Investigational Site - Downey
- GSK Investigational Site - Fresno
- GSK Investigational Site - Huntington Beach
- GSK Investigational Site - Paramount
- GSK Investigational Site - Santa Ana
- GSK Investigational Site - West Covina
Arkansas
- GSK Investigational Site - Conway
- GSK Investigational Site - Jonesboro
- GSK Investigational Site - Little Rock
Georgia
- GSK Investigational Site - Dalton
- GSK Investigational Site - Marietta
Louisiana
- GSK Investigational Site - Bossier City
- GSK Investigational Site - Metairie
Alabama
- GSK Investigational Site - Tuscaloosa
Florida
- GSK Investigational Site - Altamonte Springs
Idaho
- GSK Investigational Site - Nampa
Illinois
- GSK Investigational Site - DeKalb
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,259 participants |
| Start Date | 2009-06-03 |
| Est. Completion | 2012-06-18 |
| Phase | Phase 2 |
What the finished NCT00861744 record still lists
NCT00861744 is an interventional study that assigns participants to a tested intervention. Its 1,259 participants enrollment target places it among the larger protocols in the corpus, below the 2,421-participant average among 4 other Measles trials with a reported enrollment target (48% lower).
The record links to 4 conditions, with Measles appearing as the primary indexed condition, and to 5 interventions - of which GSK Biological's investigational vaccine 209762 is the first listed.
NCT00861744 names 20 study sites across 10 states, led by California, Arkansas, Georgia.
Frequently Asked Questions
What is clinical trial NCT00861744 about?
NCT00861744 is a clinical study titled "Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age". 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 t...
What is the current status of trial NCT00861744?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,259 participants. The study started on 2009-06-03. Estimated completion is 2012-06-18.
What conditions does trial NCT00861744 study?
This clinical trial studies the following conditions: Measles, Mumps, Rubella, Measles-Mumps-Rubella Vaccine.
What interventions are being tested in trial NCT00861744?
The interventions under investigation include: GSK Biological's investigational vaccine 209762 (BIOLOGICAL), M-M-R® II (Merck and Co) (BIOLOGICAL), Varivax® (BIOLOGICAL), Havrix® (BIOLOGICAL), Prevnar® (BIOLOGICAL).
Who is sponsoring clinical trial NCT00861744?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00861744 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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