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NCT00871117 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 478
- Enrollment target
NCT00871117: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00871117 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 478 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00871117, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 478 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the immunogenicity and safety of Kinrix when co-administered with varicella (Varivax® \[varicella virus vaccine live\], Merck and Company) and (measles mumps rubella) MMR vaccines, compared to Kinrix co-administered with MMR vaccine alone. Both Kinrix and the second dose of Varivax are indicated in children 4-6 years of age, and there is great potential for the vaccines to be given concurrently. The aim of this trial is to demonstrate that co-administered Varivax does not negatively affect the immunogenicity or reactogenicity of Kinrix.
Primary Outcome
Anti-diphteria (anti-D) and anti-tetanus (anti-T) booster response was defined as: * initially seronegative subjects (sero-) (pre-booster antibody concentration below cut-off of \< 0.1 international units per milliliter (IU/mL)) with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥0.4 IU/mL) * initially seropositive subjects (sero+) (pre-booster antibody concentration ≥0.1 IU/mL) with an increase of at least four times the pre-boo
Interventions
- BIOLOGICAL GSK Biologicals'Kinrix®
- BIOLOGICAL Merck and Company's MMRII
- BIOLOGICAL Merck and Company's Varivax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2009-03-31 |
| Est. Completion | 2010-06-15 |
| Phase | Phase 3 |
What the finished NCT00871117 record still lists
NCT00871117 is an interventional study that assigns participants to a tested intervention. The registered 478 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 3 interventions - of which GSK Biologicals'Kinrix® is the first listed.
NCT00871117 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00871117 about?
NCT00871117 is a clinical study titled "Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years". The purpose of the study is to evaluate the immunogenicity and safety of Kinrix when co-administered with varicella (Varivax® \[varicella virus vaccine live\], Merck and Company) and (measles mumps rubella) MMR vaccines, compared to Kinrix co-administered with MMR vaccine alone. Both Kinrix and the ...
What is the current status of trial NCT00871117?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 478 participants. The study started on 2009-03-31. Estimated completion is 2010-06-15.
What interventions are being tested in trial NCT00871117?
The interventions under investigation include: GSK Biologicals'Kinrix® (BIOLOGICAL), Merck and Company's MMRII (BIOLOGICAL), Merck and Company's Varivax (BIOLOGICAL).
Who is sponsoring clinical trial NCT00871117?
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 NCT00871117's enrollment target sits among peer trials
478 805th of 2000 higher than 1,194 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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