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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 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 30 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00258817
The ClinicalTrials.gov registry entry for NCT00258817 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Influenza Virus Vaccine (Fluzone®) is the first listed.
NCT00258817 reports 0 study locations.
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.
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