Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01946425
The ClinicalTrials.gov registry entry for NCT01946425 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, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
-
B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults
RECRUITING · Phase 4
-
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
RECRUITING · Phase 4
-
Bone Marrow and Peripheral Blood Immune Responses Study
RECRUITING · Phase 4
-
A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age
COMPLETED · Phase 4
-
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine
COMPLETED · Phase 4
-
Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season
COMPLETED · Phase 4
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.