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NCT00764790 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,317
- Enrollment target
NCT00764790: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00764790 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 3,317 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (330% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00764790, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,317 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.
Primary Outcome
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Interventions
- BIOLOGICAL Fluzone
- BIOLOGICAL Fluarix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,317 participants |
| Start Date | 2008-10-01 |
| Est. Completion | 2009-06-01 |
| Phase | Phase 3 |
What the finished NCT00764790 record still lists
NCT00764790 is an interventional study that assigns participants to a tested intervention. Its 3,317 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 (330% higher).
The record links to 0 conditions, and to 2 interventions - of which Fluzone is the first listed.
NCT00764790 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00764790 about?
NCT00764790 is a clinical study titled "Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children". The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.
What is the current status of trial NCT00764790?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,317 participants. The study started on 2008-10-01. Estimated completion is 2009-06-01.
What interventions are being tested in trial NCT00764790?
The interventions under investigation include: Fluzone (BIOLOGICAL), Fluarix (BIOLOGICAL).
Who is sponsoring clinical trial NCT00764790?
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 NCT00764790's enrollment target sits among peer trials
3,317 72nd of 2000 higher than 1,929 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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