MedTrace Logo

Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2020-2021 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively

NCT04551677 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-09-12

Study results available
· View outcomes & findings →

Summary

Primary Objective:

To provide serum samples (collected from participants before vaccination \[Blood Sample 1\] and after final vaccination \[Blood Sample 2\]) to Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines. In addition, serum samples from adult participants may be further analyzed by the Sponsor to assess breadth of immune response induced by the study vaccines.

Conditions

  • Influenza Immunization
  • Healthy Volunteers

Interventions

BIOLOGICAL

Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation

Pharmaceutical form: Suspension for injection in a pre-filled syringe, Route of administration: Intramuscular (IM)

BIOLOGICAL

Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2020-2021 formulation

Pharmaceutical form: Suspension for injection in a pre-filled syringe, Route of administration: IM

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
84 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2020-12-18
Completion
2020-12-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04551677 on ClinicalTrials.gov