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NCT02184572 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age
A Phase 3 study of Measles-Mumps-Rubella Vaccine and Measles; Mumps; Rubella, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,742
- Enrollment target
- 20
- Study locations
NCT02184572: Completed Phase 3 study of Measles-Mumps-Rubella Vaccine and Measles; Mumps; Rubella, sponsored by GlaxoSmithKline.
NCT02184572 is a Phase 3 study of Measles-Mumps-Rubella Vaccine and Measles; Mumps; Rubella that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,742 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (126% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02184572, a Phase 3 study of Measles-Mumps-Rubella Vaccine and Measles; Mumps; Rubella, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,742 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' trivalent MMR (Priorix), comparing it to Merck's MMR vaccine (M-M-R II), which is approved for use in the US in healthy children 12 to 15 months of age.
Primary Outcome
Fever was assessed for temperature equal to/above (≥) 38.0°C and above (\>) 39.0°C. The safety profile for fever was assessed based on the group difference (INV\_MMR minus COM\_MMR) in incidence of fever equal to or below the cut-off value.
Conditions Studied
Interventions
- BIOLOGICAL Priorix
- BIOLOGICAL M-M-R II
- BIOLOGICAL Varivax
- BIOLOGICAL Havrix
- BIOLOGICAL Prevnar 13
Study Locations (20)
California
- GSK Investigational Site - Anaheim
- GSK Investigational Site - Baldwin Park
- GSK Investigational Site - Daly City
- GSK Investigational Site - Fresno
- GSK Investigational Site - Hayward
- GSK Investigational Site - Oakland
- GSK Investigational Site - Paramount
- GSK Investigational Site - Pleasanton
- GSK Investigational Site - Roseville
- GSK Investigational Site - Sacramento
- GSK Investigational Site - Sacramento
- GSK Investigational Site - San Jose
- GSK Investigational Site - Santa Clara
- GSK Investigational Site - Walnut Creek
Arkansas
- GSK Investigational Site - Fayetteville
- GSK Investigational Site - Jonesboro
Alabama
- GSK Investigational Site - Birmingham
Arizona
- GSK Investigational Site - Tucson
Colorado
- GSK Investigational Site - Colorado Springs
Connecticut
- GSK Investigational Site - Norwich
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,742 participants |
| Start Date | 2014-08-25 |
| Est. Completion | 2015-12-22 |
| Phase | Phase 3 |
What the finished NCT02184572 record still lists
NCT02184572 is an interventional study that assigns participants to a tested intervention. Its 1,742 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (126% higher).
The record links to 2 conditions, with Measles-Mumps-Rubella Vaccine appearing as the primary indexed condition, and to 5 interventions - of which Priorix is the first listed.
NCT02184572 names 20 study sites across 6 states, led by California, Arkansas, Alabama.
Frequently Asked Questions
What is clinical trial NCT02184572 about?
NCT02184572 is a clinical study titled "Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age". The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' trivalent MMR (Priorix), comparing it to Merck's MMR vaccine (M-M-R II), which is approved for use in the US in healthy children 12 to 15 months of age.
What is the current status of trial NCT02184572?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,742 participants. The study started on 2014-08-25. Estimated completion is 2015-12-22.
What conditions does trial NCT02184572 study?
This clinical trial studies the following conditions: Measles-Mumps-Rubella Vaccine, Measles; Mumps; Rubella.
What interventions are being tested in trial NCT02184572?
The interventions under investigation include: Priorix (BIOLOGICAL), M-M-R II (BIOLOGICAL), Varivax (BIOLOGICAL), Havrix (BIOLOGICAL), Prevnar 13 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02184572?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02184572 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02184572's enrollment target sits among peer trials
1,742 129th of 2000 higher than 1,872 of 2,000 other Phase 3 trials
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