NCT04969276

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

A Phase II, Open-label Study to Assess the Safety and Immunogenicity of Fluzone® High-Dose Quadrivalent (Influenza Vaccine), 2021-2022 Formulation and a Third Dose of Moderna COVID-19 Vaccine (mRNA-1273 Vaccine) Administered Either Concomitantly or Singly in Adults 65 Years of Age and Older Previously Vaccinated With a 2-dose Schedule of Moderna COVID-19 Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participants were in the study for 6 months (approximately 180 days).

Conditions

• Influenza Immunization
• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-07-16
• Primary completion: 2022-02-08
• Completion: 2022-02-08
• First posted: 2021-07-20
• Last updated: 2025-09-12
• Results posted: 2022-12-13

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study