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NCT00835926 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 121
- Enrollment target
NCT00835926: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00835926 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 121 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00835926, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 121 participants
- Enrollment target
Study Summary
To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years. To describe the immune response at 21 days following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.
Primary Outcome
Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site. Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia
Interventions
- BIOLOGICAL Influenza virus vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2003-07 |
| Est. Completion | 2003-09 |
| Phase | Phase 4 |
What the finished NCT00835926 record still lists
NCT00835926 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Influenza virus vaccine is the first listed.
NCT00835926 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00835926 about?
NCT00835926 is a clinical study titled "A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination". To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years. To describe the immune response at 21 days following injection of the 2003-2004 formulat...
What is the current status of trial NCT00835926?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 121 participants. The study started on 2003-07. Estimated completion is 2003-09.
What interventions are being tested in trial NCT00835926?
The interventions under investigation include: Influenza virus vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00835926?
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 NCT00835926's enrollment target sits among peer trials
121 669th of 2000 higher than 1,328 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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