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NCT00772109 · ClinicalTrials.gov registry record · Phase 3
Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,292
- Enrollment target
NCT00772109: Completed Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00772109 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 4,292 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (456% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00772109, a Phase 3 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,292 participants
- Enrollment target
Study Summary
This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route. Primary Objective: * To demonstrate lot consistency of the Fluzone ID manufacturing process. * To provide information concerning the immune response of Fluzone ID. Secondary Objectives: Safety * To describe the safety profile of subjects who receive of Fluzone ID.
Primary Outcome
The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay
Interventions
- BIOLOGICAL Influenza Virus Vaccine USP Trivalent Types A and B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,292 participants |
| Start Date | 2008-10 |
| Est. Completion | 2009-07 |
| Phase | Phase 3 |
What the finished NCT00772109 record still lists
NCT00772109 is an interventional study that assigns participants to a tested intervention. Its 4,292 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 (456% higher).
The record links to 0 conditions, and to 1 intervention - of which Influenza Virus Vaccine USP Trivalent Types A and B is the first listed.
NCT00772109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00772109 about?
NCT00772109 is a clinical study titled "Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults". This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route. Primary Objective: * To demonstrate lot consistency of the Fluzone ID manufacturing process. * To provid...
What is the current status of trial NCT00772109?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,292 participants. The study started on 2008-10. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00772109?
The interventions under investigation include: Influenza Virus Vaccine USP Trivalent Types A and B (BIOLOGICAL).
Who is sponsoring clinical trial NCT00772109?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00772109's enrollment target sits among peer trials
4,292 58th of 2000 higher than 1,943 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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