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NCT00115986 · ClinicalTrials.gov registry record · Phase 1
A/H5N1in Adult - Aventis
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 452
- Enrollment target
NCT00115986: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00115986 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 452 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (653% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00115986, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 452 participants
- Enrollment target
Study Summary
The purpose of this research study is to compare how the body reacts to different strengths of the new H5N1 flu vaccine. The study will also look at how antibodies are made after a subject receives the H5N1 flu vaccine. The vaccine will be given as a shot in the arm. Participants will be randomly assigned to receive 1 of 4 different dosages of the vaccine or a placebo (dummy) dose of the vaccine. Study procedures will include a physical exam, a urine pregnancy test for women, and blood samples. Participants will be asked to complete a diary to record temperatures, medications taken, and side effects from the vaccine. Volunteers will be involved with study procedures for approximately 7 months. The study will enroll about 450-470 healthy participants, ages 18-64.
Interventions
- BIOLOGICAL Influenza A/H5N1 Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 452 participants |
| Start Date | 2005-03 |
| Est. Completion | 2006-02 |
| Phase | Phase 1 |
What the finished NCT00115986 record still lists
NCT00115986 is an interventional study that assigns participants to a tested intervention. The registered 452 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (653% higher).
The record links to 0 conditions, and to 1 intervention - of which Influenza A/H5N1 Vaccine is the first listed.
NCT00115986 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00115986 about?
NCT00115986 is a clinical study titled "A/H5N1in Adult - Aventis". The purpose of this research study is to compare how the body reacts to different strengths of the new H5N1 flu vaccine. The study will also look at how antibodies are made after a subject receives the H5N1 flu vaccine. The vaccine will be given as a shot in the arm. Participants will be randomly as...
What is the current status of trial NCT00115986?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 452 participants. The study started on 2005-03. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00115986?
The interventions under investigation include: Influenza A/H5N1 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00115986?
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 NCT00115986's enrollment target sits among peer trials
452 54th of 2000 higher than 1,947 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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