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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00100399
The ClinicalTrials.gov registry entry for NCT00100399 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,050 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fluarix is the first listed.
NCT00100399 reports 0 study locations.
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.
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