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NCT00539981 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,648
- Enrollment target
NCT00539981 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 4,648 participants.
The verdict
NCT00539981, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,648 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate a single dose of FluBlok in terms of safety, efficacy and effectiveness in prevention of influenza and influenza-like illness and assess clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three different lots of FluBlok in a subset of participants.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL FluBlok®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,648 participants |
| Start Date | 2007-09-15 |
| Est. Completion | 2008-05-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00539981
The ClinicalTrials.gov registry entry for NCT00539981 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,648 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 2 interventions - of which Placebo is the first listed.
NCT00539981 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00539981 about?
NCT00539981 is a clinical study titled "Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok". The purpose of this study was to evaluate a single dose of FluBlok in terms of safety, efficacy and effectiveness in prevention of influenza and influenza-like illness and assess clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three different lots o...
What is the current status of trial NCT00539981?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,648 participants. The study started on 2007-09-15. Estimated completion is 2008-05-28.
What interventions are being tested in trial NCT00539981?
The interventions under investigation include: Placebo (BIOLOGICAL), FluBlok® (BIOLOGICAL).
Who is sponsoring clinical trial NCT00539981?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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