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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: Completed Phase 3 study, sponsored by Sanofi.
NCT00539981 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 4,648 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (502% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Solicited reaction (reactogenicity event) was an adverse event (AE) that was pre-listed in electronic case report form(eCRF), considered to be related to vaccination and recorded by participant by means of memory aid. Injection sites reaction included pain,bruising,redness,swelling. Pain and bruising:Grade0: didn't have it at all; Grade1: noticed it, but it didn't interfere with usual activities at all; Grade2: had it, and it was bad enough to prevent a significant part of usual activities; Grad
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 |
What the finished NCT00539981 record still lists
NCT00539981 is an interventional study that assigns participants to a tested intervention. Its 4,648 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 (502% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00539981 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00539981's enrollment target sits among peer trials
4,648 54th of 2000 higher than 1,947 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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