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NCT00836953 · ClinicalTrials.gov registry record · Phase 4
Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 33
- Enrollment target
NCT00836953: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00836953 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 33 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
NCT00836953, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 33 participants
- Enrollment target
Study Summary
To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months. To describe the immunogenicity findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months
Primary Outcome
Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.
Interventions
- BIOLOGICAL Influenza virus vaccine (Pediatric formulation)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2003-09 |
| Est. Completion | 2004-07 |
| Phase | Phase 4 |
What the finished NCT00836953 record still lists
NCT00836953 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 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 (Pediatric formulation) is the first listed.
NCT00836953 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00836953 about?
NCT00836953 is a clinical study titled "Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®". To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months. To describe th...
What is the current status of trial NCT00836953?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 33 participants. The study started on 2003-09. Estimated completion is 2004-07.
What interventions are being tested in trial NCT00836953?
The interventions under investigation include: Influenza virus vaccine (Pediatric formulation) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00836953?
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 NCT00836953's enrollment target sits among peer trials
33 1528th of 2000 higher than 467 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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