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NCT01681992 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,538
- Enrollment target
NCT01681992: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01681992 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 4,538 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (488% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01681992, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,538 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate end of shelf-life potency in terms of the immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck \& Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).
Primary Outcome
For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal or above \[≥\] 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration less than \[\<\] 150 mIU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv\_MMR\_Min/Inv\_MMR\_Med vaccine in terms of seroresponse rate for measles virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv\_MMR\_Min/Inv\_MMR\_
Interventions
- BIOLOGICAL Priorix
- BIOLOGICAL M-M-R II
- BIOLOGICAL Varivax
- BIOLOGICAL Havrix
- BIOLOGICAL Prevnar 13
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,538 participants |
| Start Date | 2012-10-10 |
| Est. Completion | 2015-08-18 |
| Phase | Phase 3 |
What the finished NCT01681992 record still lists
NCT01681992 is an interventional study that assigns participants to a tested intervention. Its 4,538 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 (488% higher).
The record links to 0 conditions, and to 5 interventions - of which Priorix is the first listed.
NCT01681992 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01681992 about?
NCT01681992 is a clinical study titled "Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life". The purpose of this study is to evaluate end of shelf-life potency in terms of the immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck \& Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).
What is the current status of trial NCT01681992?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,538 participants. The study started on 2012-10-10. Estimated completion is 2015-08-18.
What interventions are being tested in trial NCT01681992?
The interventions under investigation include: Priorix (BIOLOGICAL), M-M-R II (BIOLOGICAL), Varivax (BIOLOGICAL), Havrix (BIOLOGICAL), Prevnar 13 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01681992?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01681992's enrollment target sits among peer trials
4,538 54th of 2000 higher than 1,947 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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