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Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively

NCT05050318 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-09-12

Study results available
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Summary

This was a phase IV, multi-center, open-label study. The study collected serum samples from children 6 months to less than (\<) 9 years of age who received Fluzone Quadrivalent vaccine and adults greater than or equal to (\>=) 65 years of age who received Fluzone High-Dose Quadrivalent vaccine for submission to CBER to aid in the influenza vaccine strain selection process.

Conditions

  • Influenza Immunization
  • Healthy Volunteers

Interventions

BIOLOGICAL

Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation

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

BIOLOGICAL

Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation

Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (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
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-08
Primary Completion
2021-11-10
Completion
2021-11-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05050318 on ClinicalTrials.gov