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NCT01702428 · ClinicalTrials.gov registry record · Phase 3
Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age
A Phase 3 study of Measles and Mumps, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 5,016
- Enrollment target
- 20
- Study locations
NCT01702428: Completed Phase 3 study of Measles and Mumps, sponsored by GlaxoSmithKline.
NCT01702428 is a Phase 3 study of Measles and Mumps that has completed, run by GlaxoSmithKline. The registered enrollment target is 5,016 participants, above the 1,482-participant average among 4 other Measles trials with a reported enrollment target (238% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01702428, a Phase 3 study of Measles and Mumps, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5,016 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate consistency in terms of the immune response to three different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies, and compare its immunogenicity to Merck \& Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).
Primary Outcome
Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration \<150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV\_MMR\_L1, INV\_MMR\_L2 and INV\_MMR\_L3 as analysis was performed on subjects who received one of the lots of INV\_MMR vaccine.
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 - Daly City
- GSK Investigational Site - Fresno
- GSK Investigational Site - Hayward
- GSK Investigational Site - Los Gatos
- GSK Investigational Site - Mission Hills
- GSK Investigational Site - Paramount
- GSK Investigational Site - Pleasanton
- GSK Investigational Site - Sacramento
- GSK Investigational Site - Sacramento
- GSK Investigational Site - Santa Clara
- GSK Investigational Site - Walnut Creek
Colorado
- GSK Investigational Site - Colorado Springs
- GSK Investigational Site - Colorado Springs
Alabama
- GSK Investigational Site - Dothan
Arizona
- GSK Investigational Site - Phoenix
Arkansas
- GSK Investigational Site - Fayetteville
Idaho
- GSK Investigational Site - Nampa
Illinois
- GSK Investigational Site - Evergreen Park
Iowa
- GSK Investigational Site - Ames
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,016 participants |
| Start Date | 2012-11-09 |
| Est. Completion | 2015-04-16 |
| Phase | Phase 3 |
What the finished NCT01702428 record still lists
NCT01702428 is an interventional study that assigns participants to a tested intervention. Its 5,016 participants enrollment target places it among the larger protocols in the corpus, above the 1,482-participant average among 4 other Measles trials with a reported enrollment target (238% higher).
The record links to 3 conditions, with Measles appearing as the primary indexed condition, and to 5 interventions - of which Priorix is the first listed.
NCT01702428 names 20 study sites across 8 states, led by California, Colorado, Alabama.
Frequently Asked Questions
What is clinical trial NCT01702428 about?
NCT01702428 is a clinical study titled "Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age". The purpose of this study is to evaluate consistency in terms of the immune response to three different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies, and compare its immunogenicity to Merck \& Co., Inc.'s MMR vaccine, which is approved for use in the United States ...
What is the current status of trial NCT01702428?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,016 participants. The study started on 2012-11-09. Estimated completion is 2015-04-16.
What conditions does trial NCT01702428 study?
This clinical trial studies the following conditions: Measles, Mumps, Rubella.
What interventions are being tested in trial NCT01702428?
The interventions under investigation include: Priorix (BIOLOGICAL), M-M-R II (BIOLOGICAL), Varivax (BIOLOGICAL), Havrix (BIOLOGICAL), Prevnar 13 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01702428?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01702428 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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