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NCT00382980 · ClinicalTrials.gov registry record · Phase 1
Dose-Escalating Trial Using Vero Cell-culture Derived H5N1 +/- Aluminum in Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 308
- Enrollment target
NCT00382980 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 308 participants.
The verdict
NCT00382980, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 308 participants
- Enrollment target
Study Summary
The purpose of this research study is to compare how the body reacts to different strengths of an experimental cell culture-grown whole virus A/H5N1 flu vaccine when given with or without the addition of aluminum hydroxide adjuvant. Researchers will also look at how much antibody is made to the influenza virus hemagglutinin (HA) after subjects receive the H5N1 vaccine. Three hundred healthy adults aged 18-40 years will participate for approximately 9 months, which includes screening. Participants will receive 2 doses of vaccine or placebo injected 28 days apart. Participants will have blood samples taken up to 7 times and have 8 scheduled study visits.
Interventions
- DRUG Placebo
- BIOLOGICAL Aluminum hydroxide
- BIOLOGICAL Inactivated Vero cell based whole virus influenza A/H5N1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2006-10 |
| Est. Completion | 2007-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00382980
The ClinicalTrials.gov registry entry for NCT00382980 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 308 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.
NCT00382980 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00382980 about?
NCT00382980 is a clinical study titled "Dose-Escalating Trial Using Vero Cell-culture Derived H5N1 +/- Aluminum in Adults". The purpose of this research study is to compare how the body reacts to different strengths of an experimental cell culture-grown whole virus A/H5N1 flu vaccine when given with or without the addition of aluminum hydroxide adjuvant. Researchers will also look at how much antibody is made to the infl...
What is the current status of trial NCT00382980?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 308 participants. The study started on 2006-10. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00382980?
The interventions under investigation include: Placebo (DRUG), Aluminum hydroxide (BIOLOGICAL), Inactivated Vero cell based whole virus influenza A/H5N1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00382980?
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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