A Study of the Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Subjects Aged 65 Years and Older
A Study of the Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Subjects Aged 65 Years and Older
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.
Inclusion Criteria:

 -  Aged ≥ 65 years on the day of inclusion

 -  Informed consent form has been signed and dated

 -  Able to attend all scheduled visits and to comply with all trial procedures.

 Exclusion Criteria:

 -  Participation at the time of trial enrollment (or in the 4 weeks preceding the trial
 vaccination) or planned participation during the present trial period in another
 clinical trial investigating a vaccine, drug, medical device, or medical procedure

 -  Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or
 planned receipt of any vaccine prior to Visit 2

 -  Vaccination against influenza in the past 6 months

 -  Receipt of immune globulins, blood or blood-derived products in the past 3 months

 -  Known or suspected congenital or acquired immunodeficiency; or receipt of
 immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
 within the preceding 6 months; or long-term systemic corticosteroid therapy
 (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

 -  Known systemic hypersensitivity to any of the vaccine components, or history of a
 life-threatening reaction to the vaccine used in the trial or to a vaccine containing
 any of the same substances

 -  Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on
 investigator's judgment

 -  Deprived of freedom by an administrative or court order, or in an emergency setting,
 or hospitalized involuntarily

 -  Substance abuse that, in the opinion of the investigator, might interfere with the
 trial conduct or completion

 -  Chronic illness that, in the opinion of the investigator, is at a stage where it might
 interfere with trial conduct or completion

 -  Identified as an Investigator or employee of the Investigator or trial center with
 direct involvement in the proposed trial, or identified as an immediate family member
 (i.e., parent, spouse) of the Investigator or employee with direct involvement in the
 proposed trial

 -  Personal or family history of Guillain-Barré syndrome

 -  Neoplastic disease or any hematologic malignancy (except localized skin or prostate
 cancer that is stable at the time of vaccination in the absence of therapy and
 subjects who have a history of neoplastic disease and have been disease free for ≥ 5
 years)

 -  Known allergy to iodinated radiocontrast media

 -  Moderate or severe acute illness/infection (according to investigator judgment) on the
 day of vaccination or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]). A
 prospective subject should not be included in the trial until the condition has
 resolved or the febrile event has subsided.