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NCT00280033 · ClinicalTrials.gov registry record · Phase 1
H5 Adult - Chiron Study of Bird Flu Vaccine
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 394
- Enrollment target
NCT00280033 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 394 participants.
The verdict
NCT00280033, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 394 participants
- Enrollment target
Study Summary
This study is will gather critical information on the safety, tolerability, and the immunogenicity (capability of causing an immune response) of A/H5N1 (Bird flu) virus vaccine in healthy adults. Up to 400 healthy adults, aged 18 to 64, will participate. Each subject will participate for about 7 months and will be randomly placed in one of several different study groups receiving a different dose of vaccine or placebo. All subjects will receive two injections of their assigned study product, about 28 days apart, in the muscle. Subjects will keep a journal of their temperature and any adverse effects between study visits. A small amount of blood will also be drawn before the first injection, 7 days after each injection, 1 month after the first injection, and 1 and 6 months after the second injection.
Interventions
- DRUG Placebo
- BIOLOGICAL Aluminum hydroxide
- BIOLOGICAL MF-59
- BIOLOGICAL Inactivated Influenza A/H5N1 Vaccine (Chiron)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 394 participants |
| Start Date | 2006-02 |
| Est. Completion | 2006-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00280033
The ClinicalTrials.gov registry entry for NCT00280033 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 394 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 4 interventions - of which Placebo is the first listed.
NCT00280033 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00280033 about?
NCT00280033 is a clinical study titled "H5 Adult - Chiron Study of Bird Flu Vaccine". This study is will gather critical information on the safety, tolerability, and the immunogenicity (capability of causing an immune response) of A/H5N1 (Bird flu) virus vaccine in healthy adults. Up to 400 healthy adults, aged 18 to 64, will participate. Each subject will participate for about 7 mon...
What is the current status of trial NCT00280033?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 394 participants. The study started on 2006-02. Estimated completion is 2006-11.
What interventions are being tested in trial NCT00280033?
The interventions under investigation include: Placebo (DRUG), Aluminum hydroxide (BIOLOGICAL), MF-59 (BIOLOGICAL), Inactivated Influenza A/H5N1 Vaccine (Chiron) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00280033?
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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