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NCT01691326 · ClinicalTrials.gov registry record · Phase 4
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT01691326 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 60 participants.
The verdict
NCT01691326, 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 aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone vaccine. Objective: * To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to \< 9 years of age. Observational Objectives: * To describe the immunogenicity of the 2012-2013 formulation of Fluzone 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 remaining available sera from subjects to the 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 Food and Drug Administration (FDA) to support selection and recommendation of strains for subsequent years' influenza vaccines.
Interventions
- BIOLOGICAL Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose
- BIOLOGICAL Fluzone®; Influenza Virus Vaccine, No Preservative
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01691326
The ClinicalTrials.gov registry entry for NCT01691326 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 2 interventions - of which Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose is the first listed.
NCT01691326 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01691326 about?
NCT01691326 is a clinical study titled "Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)". The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone vaccine. Objective: * To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recomm...
What is the current status of trial NCT01691326?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2012-09. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01691326?
The interventions under investigation include: Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose (BIOLOGICAL), Fluzone®; Influenza Virus Vaccine, No Preservative (BIOLOGICAL).
Who is sponsoring clinical trial NCT01691326?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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