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.
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Number of Participants With Immediate Unsolicited Adverse Events (AEs)
Timeframe: Within 30 minutes post vaccination
Number of Participants With Solicited Injection Site Reactions
Timeframe: Within 7 days post-vaccination
Number of Participants With Solicited Systemic Reactions
Timeframe: Within 7 days post-vaccination
Number of Participants With Unsolicited Adverse Events
Timeframe: Within 21 days post-vaccination
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
Timeframe: From Day 1 up to 6 months post-vaccination
Number of Participants With Medically Attended Adverse Events (MAAEs)
Timeframe: From Day 1 up to 6 months post-vaccination
Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1
Timeframe: Day 1 (pre-vaccination)
Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22
Timeframe: Day 22 (post-vaccination)
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies
Timeframe: Day 1 (pre-vaccination) and Day 22 (post-vaccination)
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution)
Timeframe: Day 1 (pre-vaccination)
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution)
Timeframe: Day 22 (post-vaccination)
Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens
Timeframe: Day 22 (post-vaccination)
Percentage of Participants With Antibody Titers >=40 (1/Dilution)
Timeframe: Day 1 (pre-vaccination)
Percentage of Participants With Antibody Titers >=40 (1/Dilution)
Timeframe: Day 22 (post-vaccination)
Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies
Timeframe: Day 1 (pre-vaccination)
Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies
Timeframe: Day 22 (post-vaccination)
Geometric Mean Concentration Ratio (GMCR) of Anti-S Binding IgG Antibodies
Timeframe: Day 1 (pre-vaccination) and Day 22 (post-vaccination)
Percentage of Participants With >=2-Fold and >=4-Fold Rise in Anti-S Binding IgG Antibodies
Timeframe: Day 22 (post-vaccination)