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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: Completed Phase 2 study, sponsored by Sanofi.
NCT00388583 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 817 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (514% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
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 |
What the finished NCT00388583 record still lists
NCT00388583 is an interventional study that assigns participants to a tested intervention. The registered 817 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (514% higher).
The record links to 0 conditions, and to 1 intervention - of which Split, Inactivated, Trivalent Influenza Vaccine is the first listed.
NCT00388583 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00388583's enrollment target sits among peer trials
817 36th of 2000 higher than 1,965 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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