The aim of the study is to assess the safety and immunogenicity of two formulations of the high-dose quadrivalent influenza vaccine compared to the licensed high-dose trivalent influenza vaccine control in healthy elderly subjects aged 65 years of age and above. Primary objectives: * To describe the safety profile of all subjects in each study group. * To demonstrate that the high-dose quadrivalent influenza vaccine induces an immune response (as assessed by HAI geometric mean titers (GMTs) that is non-inferior to responses induced by the licensed high-dose trivalent influenza vaccine for the 3 common virus strains at 28 days post-vaccination. Secondary objectives: * To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by seroconversion and seroprotection) for subjects who receive the high-dose quadrivalent influenza vaccine and the licensed high-dose trivalent influenza vaccine. * To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by GMTs, seroconversion, and seroprotection) for subjects who receive the high-dose quadrivalent influenza vaccine and the investigational high-dose trivalent influenza vaccine.
All eligible participants will be randomized to receive a single injection of either one of the high-dose quadrivalent influenza vaccine formulations or one of the high-dose trivalent influenza vaccines at Day 0. They will provide blood samples for hemagglutination inhibition (HAI) testing. Safety information as solicited, unsolicited reactions, serious adverse events, including adverse events of special interest will be collected in the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
792
0.5 mL, Intramuscular (IM), injected into the deltoid area
0.5 mL, Intramuscular (IM), injected into the deltoid area
0.5 mL, Intramuscular (IM), injected into the deltoid area
0.5 mL, Intramuscular (IM), injected into the deltoid area
Unnamed facility
Milford, Connecticut, United States
Unnamed facility
Coral Gables, Florida, United States
Unnamed facility
Wichita, Kansas, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Rochester, New York, United States
Unnamed facility
Warwick, Rhode Island, United States
Unnamed facility
Nashville, Tennessee, United States
Unnamed facility
Salt Lake City, Utah, United States
Unnamed facility
West Jordan, Utah, United States
Number of participants reporting solicited injection site and systemic events, unsolicited adverse events and serious adverse events following vaccination with a dose of Fluzone influenza vaccines
Solicited injection site: Pain, Redness, Swelling, Induration, and Ecchymosis. Solicited systemic reaction: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Unsolicited adverse events, including serious adverse events, will also be collected
Time frame: Day 0 up to 6 months post-vaccination
Hemagglutination inhibition (HAI) antibody titers to influenza virus antigens following vaccination with Fluzone High Dose quadrivalent influenza vaccine or High Dose trivalent influenza vaccine
Time frame: Day 28 post-vaccination
Seroconversion with respect to vaccine antigens following vaccination with Fluzone High-dose quadrivalent influenza vaccine or High-dose trivalent influenza vaccine
Seroconversion is defined as either a pre-vaccination titer \< 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer at 28 days after vaccination.
Time frame: Day 28 post-vaccination
Seroprotection with respect to vaccine antigens following vaccination with Fluzone High-dose quadrivalent influenza vaccine or High-dose trivalent influenza vaccine
Seroprotection is defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after vaccination.
Time frame: Day 28 post-vaccination
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