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NCT00912496 · ClinicalTrials.gov registry record · Phase 1
Booster Trial to 07-0019 With A/Anhui/05 With and Without MF59
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 637
- Enrollment target
NCT00912496 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 637 participants.
The verdict
NCT00912496, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 637 participants
- Enrollment target
Study Summary
This research will study safety and the body's immune (defense system) responses, including anti-H5 flu antibodies (the body's protective proteins found in the blood), to an inactivated influenza "H5" bird flu, virus vaccine. Participants will be assigned by chance to receive the vaccine injections with and without an adjuvant, (substance that can improve vaccine effectiveness so less vaccine may be used) MF59, or placebo (inactive substance). Five different vaccine dose strengths will be evaluated. About 735 healthy participants, ages 18-49 will be asked to take part in this study. Study procedures include physical exam, blood sampling, and use of a memory aid. Volunteers will participate for up to 13 months.
Interventions
- DRUG Placebo
- BIOLOGICAL MF-59
- BIOLOGICAL A/Anhui/05
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 637 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00912496
The ClinicalTrials.gov registry entry for NCT00912496 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 637 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.
NCT00912496 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00912496 about?
NCT00912496 is a clinical study titled "Booster Trial to 07-0019 With A/Anhui/05 With and Without MF59". This research will study safety and the body's immune (defense system) responses, including anti-H5 flu antibodies (the body's protective proteins found in the blood), to an inactivated influenza "H5" bird flu, virus vaccine. Participants will be assigned by chance to receive the vaccine injections ...
What is the current status of trial NCT00912496?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 637 participants. The study started on 2010-06. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00912496?
The interventions under investigation include: Placebo (DRUG), MF-59 (BIOLOGICAL), A/Anhui/05 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00912496?
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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