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NCT00258817 · ClinicalTrials.gov registry record · Phase 4
Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT00258817: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00258817 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00258817, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains. Observational Objectives: To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months. To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months.
Primary Outcome
GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation. Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group)
Interventions
- BIOLOGICAL Influenza Virus Vaccine (Fluzone®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2005-10 |
| Est. Completion | 2007-08 |
| Phase | Phase 4 |
What the finished NCT00258817 record still lists
NCT00258817 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Influenza Virus Vaccine (Fluzone®) is the first listed.
NCT00258817 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00258817 about?
NCT00258817 is a clinical study titled "Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine". To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains. Observational Objectives: To describe the safety of the 2005-2006 pediatri...
What is the current status of trial NCT00258817?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2005-10. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00258817?
The interventions under investigation include: Influenza Virus Vaccine (Fluzone®) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00258817?
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 NCT00258817's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 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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