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NCT01621802 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,011
- Enrollment target
NCT01621802: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01621802 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 4,011 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (420% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01621802, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,011 participants
- Enrollment target
Study Summary
The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.
Primary Outcome
Seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only.
Interventions
- BIOLOGICAL Priorix
- BIOLOGICAL M-M-R II
- BIOLOGICAL Kinrix
- BIOLOGICAL ProQuad
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,011 participants |
| Start Date | 2012-06-21 |
| Est. Completion | 2015-11-09 |
| Phase | Phase 3 |
What the finished NCT01621802 record still lists
NCT01621802 is an interventional study that assigns participants to a tested intervention. Its 4,011 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 (420% higher).
The record links to 0 conditions, and to 4 interventions - of which Priorix is the first listed.
NCT01621802 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01621802 about?
NCT01621802 is a clinical study titled "Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age". The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.
What is the current status of trial NCT01621802?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,011 participants. The study started on 2012-06-21. Estimated completion is 2015-11-09.
What interventions are being tested in trial NCT01621802?
The interventions under investigation include: Priorix (BIOLOGICAL), M-M-R II (BIOLOGICAL), Kinrix (BIOLOGICAL), ProQuad (BIOLOGICAL).
Who is sponsoring clinical trial NCT01621802?
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 NCT01621802's enrollment target sits among peer trials
4,011 61st of 2000 higher than 1,940 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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