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NCT00383123 · ClinicalTrials.gov registry record · Phase 3
Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,327
- Enrollment target
NCT00383123: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00383123 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 3,327 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (331% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00383123, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,327 participants
- Enrollment target
Study Summary
The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary Outcome
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.
Interventions
- BIOLOGICAL Fluzone
- BIOLOGICAL Fluarix™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,327 participants |
| Start Date | 2006-11-02 |
| Est. Completion | 2007-10-19 |
| Phase | Phase 3 |
What the finished NCT00383123 record still lists
NCT00383123 is an interventional study that assigns participants to a tested intervention. Its 3,327 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 (331% higher).
The record links to 0 conditions, and to 2 interventions - of which Fluzone is the first listed.
NCT00383123 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00383123 about?
NCT00383123 is a clinical study titled "Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children". The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
What is the current status of trial NCT00383123?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,327 participants. The study started on 2006-11-02. Estimated completion is 2007-10-19.
What interventions are being tested in trial NCT00383123?
The interventions under investigation include: Fluzone (BIOLOGICAL), Fluarix™ (BIOLOGICAL).
Who is sponsoring clinical trial NCT00383123?
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 NCT00383123's enrollment target sits among peer trials
3,327 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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