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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: Completed Phase 3 study, sponsored by Alachua Government Services.
NCT00800605 is a Phase 3 study that has completed, run by Alachua Government Services. The registered enrollment target is 7,250 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (839% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number of subjects developing influenza infection, as confirmed by viral culture and typing of naso-pharyngeal specimens, with a virus that is antigenically similar to one of the strains contained in the vaccine 21 days to 180 days after the date of vaccination.
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 |
What the finished NCT00800605 record still lists
NCT00800605 is an interventional study that assigns participants to a tested intervention. Its 7,250 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (839% higher).
The record links to 0 conditions, and to 2 interventions - of which Vero cell-derived, trivalent, seasonal influenza vaccine is the first listed.
NCT00800605 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00800605's enrollment target sits among peer trials
7,250 34th of 2000 higher than 1,967 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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