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NCT00566345 · ClinicalTrials.gov registry record · Phase 3
Efficacy Study of an Investigational Influenza Vaccine (Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection (CCII)
A Phase 3 study, sponsored by Alachua Government Services.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,670
- Enrollment target
NCT00566345 is a Phase 3 study that has completed, run by Alachua Government Services. The registered enrollment target is 3,670 participants.
The verdict
NCT00566345, a Phase 3 study, has completed, sponsored by Alachua Government Services.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,670 participants
- Enrollment target
Study Summary
The primary purpose of this study is to demonstrate the efficacy of an investigational Vero-cell derived influenza vaccine to prevent infection in an adult population with an influenza virus that is antigenically similar to one of the three strains in the vaccine. All subjects will be randomized to receive a single 0.5 ml intramuscular injection from one of three lots of seasonal Vero-cell derived influenza vaccine or saline placebo. Subjects will be monitored for 180 days following vaccination for occurrence of adverse events. For determining antibody response, subjects will have one blood draw before and one blood draw 21 days after vaccination.
Interventions
- BIOLOGICAL Inactivated seasonal influenza vaccine (split virus, Vero cell-derived)
- OTHER Phosphate buffered saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,670 participants |
| Start Date | 2007-11 |
| Est. Completion | 2008-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00566345
The ClinicalTrials.gov registry entry for NCT00566345 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,670 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 2 interventions - of which Inactivated seasonal influenza vaccine (split virus, Vero cell-derived) is the first listed.
NCT00566345 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00566345 about?
NCT00566345 is a clinical study titled "Efficacy Study of an Investigational Influenza Vaccine (Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection (CCII)". The primary purpose of this study is to demonstrate the efficacy of an investigational Vero-cell derived influenza vaccine to prevent infection in an adult population with an influenza virus that is antigenically similar to one of the three strains in the vaccine. All subjects will be randomized to ...
What is the current status of trial NCT00566345?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,670 participants. The study started on 2007-11. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00566345?
The interventions under investigation include: Inactivated seasonal influenza vaccine (split virus, Vero cell-derived) (BIOLOGICAL), Phosphate buffered saline (OTHER).
Who is sponsoring clinical trial NCT00566345?
This trial is sponsored by Alachua Government Services, which has 12 total clinical trials registered on ClinicalTrials.gov.
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