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Study of a Quadrivalent High-Dose Influenza Vaccine and a Moderna COVID-19 Vaccine Administered Either Concomitantly or Singly in Participants 65 Years of Age and Older Previously Vaccinated With a 2-dose Schedule of Moderna COVID-19 Vaccine

NCT04969276 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2025-09-12

Study results available
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Summary

The main purpose of this Phase II study was to assess the safety and immunogenicity of a dose of Fluzone High-Dose (HD) Quadrivalent vaccine and a third dose or booster dose of Moderna coronavirus disease 19 (COVID-19) vaccine administered concomitantly or singly in adults 65 years of age and older having received their second dose of the 2-dose schedule of Moderna COVID-19 vaccine at least 5 months before enrollment in the study.

Conditions

  • Influenza Immunization
  • Healthy Volunteers

Interventions

BIOLOGICAL

Quadrivalent Inactivated Influenza High Dose

Sterile suspension for injection in a pre-filled syringe Intramuscular injection

BIOLOGICAL

COVID-19 mRNA Vaccine (nucleoside modified)

Sterile suspension (white to off-white) in multidose vial Intramuscular injection

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-16
Primary Completion
2022-02-08
Completion
2022-02-08
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 NCT04969276 on ClinicalTrials.gov