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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: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01691326 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Solicited injection site reactions (Age 6 to \< 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, \>103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, \>3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritabilit
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 |
What the finished NCT01691326 record still lists
NCT01691326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01691326's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 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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