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

NCT03308825 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

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 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

Interventions

BIOLOGICAL

Fluzone Quadrivalent vaccine

0.25 mL, Intramuscular

BIOLOGICAL

Fluzone Quadrivalent vaccine

0.5 mL, Intramuscular

BIOLOGICAL

Fluzone High-Dose vaccine

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-11
Primary Completion
2017-11-22
Completion
2017-11-22
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 NCT03308825 on ClinicalTrials.gov