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NCT00561002 · ClinicalTrials.gov registry record · Phase 4
Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine
A Phase 4 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT00561002: Completed Phase 4 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00561002 is a Phase 4 study of Influenza that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 34 participants, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00561002, a Phase 4 study of Influenza, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2007-2008 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.
Primary Outcome
Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1.
Conditions Studied
Interventions
- BIOLOGICAL 2007-2008 Influenza Virus Vaccine
Study Locations (1)
Virginia
- - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2007-10 |
| Est. Completion | 2008-06 |
| Phase | Phase 4 |
What the finished NCT00561002 record still lists
NCT00561002 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which 2007-2008 Influenza Virus Vaccine is the first listed.
NCT00561002 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT00561002 about?
NCT00561002 is a clinical study titled "Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine". To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2007-2008 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.
What is the current status of trial NCT00561002?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2007-10. Estimated completion is 2008-06.
What conditions does trial NCT00561002 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT00561002?
The interventions under investigation include: 2007-2008 Influenza Virus Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00561002?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00561002 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00561002's enrollment target sits among peer trials
34 136th of 156 higher than 20 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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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A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age
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-
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine
COMPLETED · Phase 4
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