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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: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00755274 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 32 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
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.
Primary Outcome
Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
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 |
What the finished NCT00755274 record still lists
NCT00755274 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 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 No Preservative: Pediatric Dose is the first listed.
NCT00755274 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00755274's enrollment target sits among peer trials
32 1534th of 2000 higher than 457 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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