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NCT00664417 · ClinicalTrials.gov registry record · Phase 1
Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 375
- Enrollment target
NCT00664417 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 375 participants.
The verdict
NCT00664417, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 375 participants
- Enrollment target
Study Summary
Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.
Interventions
- BIOLOGICAL Monovalent subvirion H5N1 influenza vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2008-04 |
| Est. Completion | 2010-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00664417
The ClinicalTrials.gov registry entry for NCT00664417 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 375 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 Monovalent subvirion H5N1 influenza vaccine is the first listed.
NCT00664417 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00664417 about?
NCT00664417 is a clinical study titled "Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine". Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding ...
What is the current status of trial NCT00664417?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 375 participants. The study started on 2008-04. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00664417?
The interventions under investigation include: Monovalent subvirion H5N1 influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00664417?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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