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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 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,950 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02915302
The ClinicalTrials.gov registry entry for NCT02915302 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,950 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 Fluzone Quadrivalent vaccine, No Preservative is the first listed.
NCT02915302 reports 0 study locations.
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.
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