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NCT02915302 · ClinicalTrials.gov registry record · Phase 4
Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,950
- Enrollment target
NCT02915302: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT02915302 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,950 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (276% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02915302, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,950 participants
- Enrollment target
Study Summary
The aim of the study was to describe the safety and immunogenicity of a 0.5-mL dose (15 μg hemagglutinin \[HA\] per strain) of Fluzone Quadrivalent vaccine in children 6 to \<36 months of age. Primary objective: * To compare the rate of any fever (temperature ≥100.4 degrees Fahrenheit \[38.0 degrees Celsius) following a 0.5-mL dose of Fluzone Quadrivalent vaccine to that following a 0.25-mL dose of Fluzone Quadrivalent vaccine during the 7 days after either vaccination (Dose 1 and Dose 2 combined) in participants 6 to \< 36 months of age. Secondary objective: * To compare antibody responses induced by a 0.5-mL dose of Fluzone Quadrivalent vaccine to those induced by a 0.25-mL dose of Fluzone Quadrivalent vaccine as assessed by geometric mean titer (GMT) ratios and seroconversion rate differences after the final vaccination in participants 6 to \< 36 months of age. Other objectives: * To describe the safety of 2 different dose levels of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in participants 6 to \< 36 months of age. * To describe the immunogenicity of 2 different dose levels of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in participants 6 months to \< 36 months of age. * To submit available sera from approximately 30 participants to the Center for Biologics Evaluation and Research for further analysis by the World Health Organization, the Centers for Disease Control and Prevention, and the FDA to support formulation recommendations for subsequent influenza vaccines.
Primary Outcome
Fever rate was defined as percentage of participants with fever (temperature \>=100.4 degrees Fahrenheit \[38.0 degrees Celsius\]) following vaccination with Fluzone Quadrivalent vaccine.
Interventions
- BIOLOGICAL Fluzone Quadrivalent vaccine, No Preservative
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,950 participants |
| Start Date | 2016-09-23 |
| Est. Completion | 2017-03-06 |
| Phase | Phase 4 |
What the finished NCT02915302 record still lists
NCT02915302 is an interventional study that assigns participants to a tested intervention. Its 1,950 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (276% higher).
The record links to 0 conditions, and to 1 intervention - of which Fluzone Quadrivalent vaccine, No Preservative is the first listed.
NCT02915302 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02915302 about?
NCT02915302 is a clinical study titled "Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children". The aim of the study was to describe the safety and immunogenicity of a 0.5-mL dose (15 μg hemagglutinin \[HA\] per strain) of Fluzone Quadrivalent vaccine in children 6 to \<36 months of age. Primary objective: * To compare the rate of any fever (temperature ≥100.4 degrees Fahrenheit \[38.0 degre...
What is the current status of trial NCT02915302?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,950 participants. The study started on 2016-09-23. Estimated completion is 2017-03-06.
What interventions are being tested in trial NCT02915302?
The interventions under investigation include: Fluzone Quadrivalent vaccine, No Preservative (BIOLOGICAL).
Who is sponsoring clinical trial NCT02915302?
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 NCT02915302's enrollment target sits among peer trials
1,950 44th of 2000 higher than 1,957 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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