Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00782431 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older
A Phase 3 study, sponsored by Alachua Government Services.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,208
- Enrollment target
NCT00782431 is a Phase 3 study that has completed, run by Alachua Government Services. The registered enrollment target is 3,208 participants.
The verdict
NCT00782431, a Phase 3 study, has completed, sponsored by Alachua Government Services.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,208 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the effectiveness (seroprotection and seroconversion as measured by the hemagglutination inhibition \[HI\] assay) of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine in adults 50 years of age and older. Subjects will be randomized in a double-blind fashion to receive a single intramuscular injection of either the investigational vaccine or a licensed egg-derived seasonal influenza vaccine. Blood will be drawn from all subjects for a determination of HI antibody titers on Days 0 and 21, body temperature and injection site reactions will be monitored daily for 7 days. In addition, subjects will be monitored for adverse events and rises in body temperature until Day 21 and again until Day 180.
Interventions
- BIOLOGICAL Vero cell derived, trivalent, seasonal influenza vaccine
- BIOLOGICAL Licensed egg-derived, trivalent seasonal influenza vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,208 participants |
| Start Date | 2008-11 |
| Est. Completion | 2009-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00782431
The ClinicalTrials.gov registry entry for NCT00782431 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,208 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.
NCT00782431 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00782431 about?
NCT00782431 is a clinical study titled "Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older". The purpose of this study is to demonstrate the effectiveness (seroprotection and seroconversion as measured by the hemagglutination inhibition \[HI\] assay) of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine in adults 50 years of age and older. Subjects will be randomize...
What is the current status of trial NCT00782431?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,208 participants. The study started on 2008-11. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00782431?
The interventions under investigation include: Vero cell derived, trivalent, seasonal influenza vaccine (BIOLOGICAL), Licensed egg-derived, trivalent seasonal influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00782431?
This trial is sponsored by Alachua Government Services, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.