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NCT03308825 · ClinicalTrials.gov registry record · Phase 4

Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines

A Phase 4 study of Influenza and FLU, sponsored by Sanofi Pasteur, a Sanofi Company.

Completed
Registry status
Phase 4
Development phase
240
Enrollment target
3
Study locations

NCT03308825 is a Phase 4 study of Influenza and FLU that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 240 participants, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT03308825, a Phase 4 study of Influenza and FLU, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.

COMPLETED
Registry status
Phase 4
Development phase
240 participants
Enrollment target
3
Study locations

Study Summary

The aim of the study was to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone Quadrivalent vaccine in children 6 months to \< 9 years of age, and in adults 18 to \< 65 years of age, and to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.

Conditions Studied

Interventions

  • BIOLOGICAL Fluzone Quadrivalent vaccine
  • BIOLOGICAL Fluzone High-Dose vaccine

Study Locations (3)

Iowa

  • Sanofi Pasteur Investigational Site 003 - Council Bluffs

Kentucky

  • Sanofi Pasteur Investigational Site 002 - Bardstown

Louisiana

  • Sanofi Pasteur Investigational Site 001 - Metairie

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2017-09-11
Est. Completion 2017-11-22
Phase Phase 4

Sponsor

Sanofi Pasteur, a Sanofi Company

153 total trials

What the Registry Record Tells You About NCT03308825

The ClinicalTrials.gov registry entry for NCT03308825 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Fluzone Quadrivalent vaccine is the first listed.

NCT03308825 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Iowa, Kentucky, Louisiana.

Frequently Asked Questions

What is clinical trial NCT03308825 about?

NCT03308825 is a clinical study titled "Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines". The aim of the study was to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone Quadrivalent vaccine in children 6 months to \< 9 years of age, and in adults 18 to \< 65 years of age, and to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone Hig...

What is the current status of trial NCT03308825?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 240 participants. The study started on 2017-09-11. Estimated completion is 2017-11-22.

What conditions does trial NCT03308825 study?

This clinical trial studies the following conditions: Influenza, FLU.

What interventions are being tested in trial NCT03308825?

The interventions under investigation include: Fluzone Quadrivalent vaccine (BIOLOGICAL), Fluzone High-Dose vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT03308825?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03308825 being conducted?

This trial has 3 study locations across Iowa, Kentucky, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.