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NCT00133523 · ClinicalTrials.gov registry record · Phase 4
FLU-VACS Comparative Study in Adults
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 2,349
- Enrollment target
NCT00133523 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 2,349 participants.
The verdict
NCT00133523, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 2,349 participants
- Enrollment target
Study Summary
The purpose of this study is to compare 2 licensed flu vaccines to each other and to placebo (inactive substance). The study will be conducted among healthy adult participants aged 18-49 years and is expected to last 3 years. During year 1, participants will be assigned to receive 1 of the 2 licensed flu vaccines or placebo, given as either nasal spray (live-attenuated vaccine or placebo) or injection (inactivated vaccine or placebo). Participants will receive the same assigned vaccine or placebo during year 2. During year 3, participants will be followed, but will not receive flu vaccine. Each year blood samples will be collected before and 1 month after each vaccination and at the end of each flu season in order to measure how the body responds to the vaccine and how well participants were protected from the flu. During the flu season, participants with flu-like illness will provide information on symptoms and provide a throat swab to test for virus identification.
Interventions
- OTHER Placebo
- BIOLOGICAL Trivalent inactivated influenza vaccine
- BIOLOGICAL Cold-adapted live attenuated influenza virus vaccine, trivalent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,349 participants |
| Start Date | 2004-10 |
| Est. Completion | 2007-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00133523
The ClinicalTrials.gov registry entry for NCT00133523 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 2,349 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 3 interventions - of which Placebo is the first listed.
NCT00133523 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00133523 about?
NCT00133523 is a clinical study titled "FLU-VACS Comparative Study in Adults". The purpose of this study is to compare 2 licensed flu vaccines to each other and to placebo (inactive substance). The study will be conducted among healthy adult participants aged 18-49 years and is expected to last 3 years. During year 1, participants will be assigned to receive 1 of the 2 license...
What is the current status of trial NCT00133523?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 2,349 participants. The study started on 2004-10. Estimated completion is 2007-07.
What interventions are being tested in trial NCT00133523?
The interventions under investigation include: Placebo (OTHER), Trivalent inactivated influenza vaccine (BIOLOGICAL), Cold-adapted live attenuated influenza virus vaccine, trivalent (BIOLOGICAL).
Who is sponsoring clinical trial NCT00133523?
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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