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NCT00388583 · ClinicalTrials.gov registry record · Phase 2
Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 817
- Enrollment target
NCT00388583 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 817 participants.
The verdict
NCT00388583, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 817 participants
- Enrollment target
Study Summary
As a result of the safety and immunogenicity data generated from earlier dose-ranging studies, the present formulation has been selected for further development in the elderly. Primary Objective: To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects receiving standard Fluzone®. Secondary Objectives: Immunogenicity: To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®. Safety: To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.
Interventions
- BIOLOGICAL Split, Inactivated, Trivalent Influenza Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 817 participants |
| Start Date | 2006-09 |
| Est. Completion | 2008-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00388583
The ClinicalTrials.gov registry entry for NCT00388583 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 817 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Split, Inactivated, Trivalent Influenza Vaccine is the first listed.
NCT00388583 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00388583 about?
NCT00388583 is a clinical study titled "Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects". As a result of the safety and immunogenicity data generated from earlier dose-ranging studies, the present formulation has been selected for further development in the elderly. Primary Objective: To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects rec...
What is the current status of trial NCT00388583?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 817 participants. The study started on 2006-09. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00388583?
The interventions under investigation include: Split, Inactivated, Trivalent Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00388583?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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