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NCT01946425 · ClinicalTrials.gov registry record · Phase 4
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine
A Phase 4 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT01946425: Completed Phase 4 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01946425 is a Phase 4 study of Influenza that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 60 participants, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01946425, a Phase 4 study of Influenza, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study Summary
The aim of this study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent vaccine in participants aged 6 months to \< 9 years at enrollment, divided into 2 age strata (6 months to \< 36 months and 3 years to \< 9 years) Primary Objective: * To describe the safety of the 2013-2014 formulation of Fluzone Quadrivalent 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 2013-2014 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 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 formulation recommendations for subsequent influenza vaccines.
Primary Outcome
Solicited injection-site reactions (6 months to \<36 months of age): Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite loss, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥50 mm; Fever, \>103.1ºF; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \>3 hours; Drowsiness, Sleeping most of the time; Appetite lost, Refuses ≥3 feeds/meals or refuses mo
Conditions Studied
Interventions
- BIOLOGICAL Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative
Study Locations (2)
Kentucky
- - Bardstown
Utah
- - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-07 |
| Phase | Phase 4 |
What the finished NCT01946425 record still lists
NCT01946425 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 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative is the first listed.
NCT01946425 reports a single indexed study location in Kentucky, Utah.
Frequently Asked Questions
What is clinical trial NCT01946425 about?
NCT01946425 is a clinical study titled "Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine". The aim of this study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent vaccine in participants aged 6 months to \< 9 years at enrollment, divided into 2 age strata (6 months to \< 36 months and 3 years to \< 9 years) Primary Objective: * To describe the safety of the 2013-2014...
What is the current status of trial NCT01946425?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2013-09. Estimated completion is 2014-07.
What conditions does trial NCT01946425 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT01946425?
The interventions under investigation include: Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative (BIOLOGICAL).
Who is sponsoring clinical trial NCT01946425?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01946425 being conducted?
This trial has 2 study locations across Kentucky, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01946425's enrollment target sits among peer trials
60 117th of 156 higher than 35 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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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Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine
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