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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00115986
The ClinicalTrials.gov registry entry for NCT00115986 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 452 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 Influenza A/H5N1 Vaccine is the first listed.
NCT00115986 reports 0 study locations.
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.
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