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NCT00819013 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 87
- Enrollment target
NCT00819013: Completed Phase 1 study, sponsored by Sanofi.
NCT00819013 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 87 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00819013, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 87 participants
- Enrollment target
Study Summary
This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered. Subjects will be randomized according to a randomization scheme.
Interventions
- BIOLOGICAL Saline placebo
- BIOLOGICAL Influenza A Vaccine: ACAM FLU-A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2007-07 |
| Est. Completion | 2009-02 |
| Phase | Phase 1 |
What the finished NCT00819013 record still lists
NCT00819013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 2 interventions - of which Saline placebo is the first listed.
NCT00819013 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00819013 about?
NCT00819013 is a clinical study titled "Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults". This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered. Subjects will be randomized according to a randomization scheme.
What is the current status of trial NCT00819013?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 87 participants. The study started on 2007-07. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00819013?
The interventions under investigation include: Saline placebo (BIOLOGICAL), Influenza A Vaccine: ACAM FLU-A (BIOLOGICAL).
Who is sponsoring clinical trial NCT00819013?
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 NCT00819013's enrollment target sits among peer trials
87 651st of 2000 higher than 1,349 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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