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NCT00783926 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of a H5N1 Influenza Vaccine (Reverse Genetic Reassortant)
A Phase 1 study, sponsored by Alachua Government Services.
- Completed
- Registry status
- Phase 1
- Development phase
- 422
- Enrollment target
NCT00783926 is a Phase 1 study that has completed, run by Alachua Government Services. The registered enrollment target is 422 participants.
The verdict
NCT00783926, a Phase 1 study, has completed, sponsored by Alachua Government Services.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 422 participants
- Enrollment target
Study Summary
The objectives of this study are to assess the dose-related safety and immunogenicity of six different dose levels of inactivated, Vero cell-derived reverse genetic reassortant A/H5N1/Indonesia/05/2005 influenza vaccine in a healthy young adult population. Subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Blood will be drawn from all subjects for serum antibody determination on Days 0, 21, 42 and 180. Body temperature will be measured daily for 6 days following vaccination. Injection site reactions and systemic reactions will be monitored throughout the entire 180 days of the study. Safety data obtained at 7 days after the first vaccination for all dose levels in Cohort 1 will be reviewed by a Data Monitoring Committee and a recommendation will be obtained whether to proceed to the second vaccination of Cohort 1 and to the first vaccination of Cohort 2.
Interventions
- BIOLOGICAL H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 422 participants |
| Start Date | 2008-07 |
| Est. Completion | 2009-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00783926
The ClinicalTrials.gov registry entry for NCT00783926 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 422 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alachua Government Services, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen) is the first listed.
NCT00783926 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00783926 about?
NCT00783926 is a clinical study titled "Phase 1 Study of a H5N1 Influenza Vaccine (Reverse Genetic Reassortant)". The objectives of this study are to assess the dose-related safety and immunogenicity of six different dose levels of inactivated, Vero cell-derived reverse genetic reassortant A/H5N1/Indonesia/05/2005 influenza vaccine in a healthy young adult population. Subjects will receive 2 vaccinations (21 da...
What is the current status of trial NCT00783926?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 422 participants. The study started on 2008-07. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00783926?
The interventions under investigation include: H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00783926?
This trial is sponsored by Alachua Government Services, which has 12 total clinical trials registered on ClinicalTrials.gov.
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