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NCT02058563 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Volunteers, Seven Years of Age and Older
A Phase 3 study of Measles and Mumps, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 996
- Enrollment target
- 17
- Study locations
NCT02058563: Completed Phase 3 study of Measles and Mumps, sponsored by GlaxoSmithKline.
NCT02058563 is a Phase 3 study of Measles and Mumps that has completed, run by GlaxoSmithKline. The registered enrollment target is 996 participants, below the 2,487-participant average among 4 other Measles trials with a reported enrollment target (60% lower). The trial reports 17 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02058563, a Phase 3 study of Measles and Mumps, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 996 participants
- Enrollment target
- 17
- Study locations
Study Summary
The purpose of this study is to evaluate the immunogenicity and safety of GSK's trivalent MMR (Priorix®), comparing it to Merck"s MMR vaccine (M-M-R®II), which is approved for use in the US.
Primary Outcome
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in milli International Units per milliliter (mIU/mL). Seropositivity was defined as subjects with anti-measles virus antibody concentration equal or greater than 150 mIU/mL.
Interventions
- BIOLOGICAL Priorix®
- BIOLOGICAL Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine
Study Locations (17)
Other
- GSK Investigational Site - Tartu
- GSK Investigational Site - Bratislava
- GSK Investigational Site - Dolný Kubín
- GSK Investigational Site - Dunajská Streda
- GSK Investigational Site - Martin
- GSK Investigational Site - Ružomberok
- GSK Investigational Site - Zlaté Moravce
Arizona
- GSK Investigational Site - Chandler
- GSK Investigational Site - Mesa
Florida
- GSK Investigational Site - Miami
- GSK Investigational Site - Miami
Alabama
- GSK Investigational Site - Birmingham
Illinois
- GSK Investigational Site - Chicago
Minnesota
- GSK Investigational Site - Edina
Missouri
- GSK Investigational Site - St Louis
Ohio
- GSK Investigational Site - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 996 participants |
| Start Date | 2014-07-01 |
| Est. Completion | 2015-09-17 |
| Phase | Phase 3 |
What the finished NCT02058563 record still lists
NCT02058563 is an interventional study that assigns participants to a tested intervention. The registered 996 participants enrollment target is mid-sized for trials with a published cap, below the 2,487-participant average among 4 other Measles trials with a reported enrollment target (60% lower).
The record links to 3 conditions, with Measles appearing as the primary indexed condition, and to 2 interventions - of which Priorix® is the first listed.
NCT02058563 lists 17 locations in 9 states (Other, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT02058563 about?
NCT02058563 is a clinical study titled "Immunogenicity and Safety of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Volunteers, Seven Years of Age and Older". The purpose of this study is to evaluate the immunogenicity and safety of GSK's trivalent MMR (Priorix®), comparing it to Merck"s MMR vaccine (M-M-R®II), which is approved for use in the US.
What is the current status of trial NCT02058563?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 996 participants. The study started on 2014-07-01. Estimated completion is 2015-09-17.
What conditions does trial NCT02058563 study?
This clinical trial studies the following conditions: Measles, Mumps, Rubella.
What interventions are being tested in trial NCT02058563?
The interventions under investigation include: Priorix® (BIOLOGICAL), Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02058563?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02058563 being conducted?
This trial has 17 study locations across Alabama, Arizona, Florida, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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