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NCT02539108 · ClinicalTrials.gov registry record · Phase 4
Safety and Immunogenicity of the 2015-2016 Formulation of Fluzone® Quadrivalent (Influenza Vaccine) Among Healthy Children
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT02539108 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 60 participants.
The verdict
NCT02539108, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
The study will evaluate the safety and immunogenicity of the 2015-2016 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to \< 9 years of age. Objective: * To describe the safety of the 2015-2016 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with ACIP recommendations, in children 6 months to \< 9 years of age. Observational objectives: * To describe the immunogenicity of the 2015-2016 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to \< 9 years of age. * To submit available sera from each subject to Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the FDA to support formulation recommendations for subsequent influenza vaccines.
Interventions
- BIOLOGICAL Fluzone® Quadrivalent Influenza Vaccine, No Preservative
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2015-08 |
| Est. Completion | 2016-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02539108
The ClinicalTrials.gov registry entry for NCT02539108 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 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 Influenza Vaccine, No Preservative is the first listed.
NCT02539108 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02539108 about?
NCT02539108 is a clinical study titled "Safety and Immunogenicity of the 2015-2016 Formulation of Fluzone® Quadrivalent (Influenza Vaccine) Among Healthy Children". The study will evaluate the safety and immunogenicity of the 2015-2016 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to \< 9 years of age. Objecti...
What is the current status of trial NCT02539108?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2015-08. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02539108?
The interventions under investigation include: Fluzone® Quadrivalent Influenza Vaccine, No Preservative (BIOLOGICAL).
Who is sponsoring clinical trial NCT02539108?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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