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Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations

NCT02908269 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-03-29

Study results available
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Summary

The aim of the study was to describe the safety and immunogenicity of the 2016-2017 formulations of Fluzone Quadrivalent vaccine in children 3 to \< 9 years of age and in adults 18 to \< 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥65 years of age.

Primary Observational Objectives

* To describe the safety of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to \< 9 years of age and adults 18 to \< 65 years of age, and the safety of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.

Observational Objectives:

* To describe the immunogenicity of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to \< 9 years of age and adults 18 to \< 65 years of age, and the immunogenicity of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
* To submit available sera from approximately 90 participants (30 participants 3 to \< 9 years of age and 30 participants 18 to \< 65 years of age who receive Fluzone Quadrivalent vaccine, and 30 participants ≥ 65 years of age who receive Fluzone High-Dose vaccine) to 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

Interventions

BIOLOGICAL

Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative

0.5 mL, Intramuscular

BIOLOGICAL

Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative

0.5 mL, Intramuscular

BIOLOGICAL

Fluzone High-Dose, vaccine, 2016-2017 formulation

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-15
Primary Completion
2016-12-09
Completion
2016-12-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02908269 on ClinicalTrials.gov