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NCT00831987 · ClinicalTrials.gov registry record · Phase 4
Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
NCT00831987: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00831987 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 120 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
NCT00831987, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
Study Summary
To observe and to describe the safety during Days 0 to 21 following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years. To measure and to describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.
Primary Outcome
Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site. Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia
Interventions
- BIOLOGICAL Fluzone®: Influenza virus vaccine 2004-2005 formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2004-08 |
| Est. Completion | 2006-02 |
| Phase | Phase 4 |
What the finished NCT00831987 record still lists
NCT00831987 is an interventional study that assigns participants to a tested intervention. The registered 120 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 Fluzone®: Influenza virus vaccine 2004-2005 formulation is the first listed.
NCT00831987 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00831987 about?
NCT00831987 is a clinical study titled "Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine". To observe and to describe the safety during Days 0 to 21 following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years. To measure and to describe the immune response (antibodies to hemagglutin...
What is the current status of trial NCT00831987?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2004-08. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00831987?
The interventions under investigation include: Fluzone®: Influenza virus vaccine 2004-2005 formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT00831987?
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 NCT00831987's enrollment target sits among peer trials
120 673rd of 2000 higher than 1,289 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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