At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Quadrivalent Inactivated Influenza High Dose and COVID-19 mRNA Vaccine (nucleoside modified) for Influenza Immunization and Healthy Volunteers. Completed, enrolled 306 participants across 6 sites.
Detailed 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.
Study Details
Timeline
Interventions
Sterile suspension for injection in a pre-filled syringe Intramuscular injection
Sterile suspension (white to off-white) in multidose vial Intramuscular injection