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NCT00755274 · ClinicalTrials.gov registry record · Phase 4
Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 32
- Enrollment target
NCT00755274 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 32 participants.
The verdict
NCT00755274, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 32 participants
- Enrollment target
Study Summary
Primary Objective: To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study. Observational Objectives: To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to \< 5 years of age. To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to \< 5 years of age.
Interventions
- BIOLOGICAL Influenza Virus Vaccine No Preservative: Pediatric Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2008-09 |
| Est. Completion | 2009-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00755274
The ClinicalTrials.gov registry entry for NCT00755274 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 32 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 No Preservative: Pediatric Dose is the first listed.
NCT00755274 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00755274 about?
NCT00755274 is a clinical study titled "Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®". Primary Objective: To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study. Observational Objectives: To describe the safety of th...
What is the current status of trial NCT00755274?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2008-09. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00755274?
The interventions under investigation include: Influenza Virus Vaccine No Preservative: Pediatric Dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT00755274?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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