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NCT00800605 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection
A Phase 3 study, sponsored by Alachua Government Services.
- Completed
- Registry status
- Phase 3
- Development phase
- 7,250
- Enrollment target
NCT00800605 is a Phase 3 study that has completed, run by Alachua Government Services. The registered enrollment target is 7,250 participants.
The verdict
NCT00800605, a Phase 3 study, has completed, sponsored by Alachua Government Services.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 7,250 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the efficacy of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine to prevent infection with an influenza virus that is antigenically similar to one of the three strains in the vaccine. Subjects will be randomized in a double-blind fashion to receive a single intramuscular injection of either the investigational vaccine or placebo. Blood will be drawn from all subjects for a determination of hemagglutination inhibition antibody titers on Days 0 and 21, body temperature and injection site reactions will be monitored daily for 7 days. In addition, subjects must return to the clinic promptly to have swab samples of their nose and throat taken whenever they feel flu symptoms and all subjects will be monitored for adverse events until Day 180.
Interventions
- BIOLOGICAL Vero cell-derived, trivalent, seasonal influenza vaccine
- BIOLOGICAL Placebo: Phosphate-buffered saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7,250 participants |
| Start Date | 2008-12 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00800605
The ClinicalTrials.gov registry entry for NCT00800605 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 7,250 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 Vero cell-derived, trivalent, seasonal influenza vaccine is the first listed.
NCT00800605 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00800605 about?
NCT00800605 is a clinical study titled "Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection". The purpose of this study is to demonstrate the efficacy of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine to prevent infection with an influenza virus that is antigenically similar to one of the three strains in the vaccine. Subjects will be randomized in a double-blind...
What is the current status of trial NCT00800605?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 7,250 participants. The study started on 2008-12. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00800605?
The interventions under investigation include: Vero cell-derived, trivalent, seasonal influenza vaccine (BIOLOGICAL), Placebo: Phosphate-buffered saline (BIOLOGICAL).
Who is sponsoring clinical trial NCT00800605?
This trial is sponsored by Alachua Government Services, which has 12 total clinical trials registered on ClinicalTrials.gov.
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