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Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively

NCT04109222 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-09-12

Study results available
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Summary

The primary objective of the study was to provide sera (collected from participants before vaccination \[Blood Sample 1\] and after final vaccination \[Blood Sample 2\]) 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

Interventions

BIOLOGICAL

Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Fluzone High-Dose vaccine, 2019-2020 formulation

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
83 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2019-12-10
Completion
2019-12-10
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 NCT04109222 on ClinicalTrials.gov