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NCT00258830 · ClinicalTrials.gov registry record · Phase 4
Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
NCT00258830 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 120 participants.
The verdict
NCT00258830, 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 describe the safety during Days 0 to 21 following injection of the 2005-2006 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 (antibodies to hemagglutinin) 21 days following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone, in subjects aged 18-59 years and subjects aged ≥ 60 years. To submit remaining available sera to the Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.
Interventions
- BIOLOGICAL Fluzone®: Influenza Virus Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2005-09 |
| Est. Completion | 2007-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00258830
The ClinicalTrials.gov registry entry for NCT00258830 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 120 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 Fluzone®: Influenza Virus Vaccine is the first listed.
NCT00258830 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00258830 about?
NCT00258830 is a clinical study titled "Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine". To describe the safety during Days 0 to 21 following injection of the 2005-2006 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 (antibodies to hemagglutinin) 21 days following injection...
What is the current status of trial NCT00258830?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2005-09. Estimated completion is 2007-03.
What interventions are being tested in trial NCT00258830?
The interventions under investigation include: Fluzone®: Influenza Virus Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00258830?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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