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NCT00100399 · ClinicalTrials.gov registry record · Phase 3
Fluarix Immunogenicity and Safety Trial
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,050
- Enrollment target
NCT00100399: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00100399 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,050 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00100399, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,050 participants
- Enrollment target
Study Summary
The purpose of this study is to test the immune response caused by investigational Fluarix vaccine in healthy people aged between 18-64 years in the U.S.A. Up to 1050 volunteers at 4 centers will receive Fluarix or Placebo (saline), and their responses will then be compared. Subjects will be placed by age into 2 groups (18 to 49 years old and 50 to 64 years old), then randomly assigned to receive a dose of Fluarix or Placebo by injection into a muscle. There will be 2 phases in this study: (1) the active study phase (2 visits) for all subjects; and (2) the cross-over phase, only for subjects enrolled in the placebo group who accept to receive Fluarix. Blood samples will be obtained in order to measure immune response to the vaccine. On the day of vaccination, volunteers will receive a diary card to record information on symptoms experienced during the next 3 days. Subject participation in either group will be up to 2 months.
Interventions
- BIOLOGICAL Fluarix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,050 participants |
| Start Date | 2004-12 |
| Est. Completion | 2004-12 |
| Phase | Phase 3 |
What the finished NCT00100399 record still lists
NCT00100399 is an interventional study that assigns participants to a tested intervention. Its 1,050 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 (36% higher).
The record links to 0 conditions, and to 1 intervention - of which Fluarix is the first listed.
NCT00100399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00100399 about?
NCT00100399 is a clinical study titled "Fluarix Immunogenicity and Safety Trial". The purpose of this study is to test the immune response caused by investigational Fluarix vaccine in healthy people aged between 18-64 years in the U.S.A. Up to 1050 volunteers at 4 centers will receive Fluarix or Placebo (saline), and their responses will then be compared. Subjects will be placed ...
What is the current status of trial NCT00100399?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,050 participants. The study started on 2004-12. Estimated completion is 2004-12.
What interventions are being tested in trial NCT00100399?
The interventions under investigation include: Fluarix (BIOLOGICAL).
Who is sponsoring clinical trial NCT00100399?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00100399's enrollment target sits among peer trials
1,050 282nd of 2000 higher than 1,718 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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