Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Japanese Adults 60 Years of Age and Older
Condition: Influenza Immunization; Healthy Volunteers
MeSH terms: Influenza, Human
Intervention: High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD); Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD)
Intervention description: Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: SC
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants randomized in each group were stratified by site and age (60 to 64, 65 to 74, and 75 years of age and older).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Modified double-blind: the participant and the Investigator remain unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member will administer the appropriate vaccine but will not be involved in the immunogenicity and safety evaluations.
Enrollment: 2100.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Primary Objective:

      To demonstrate that QIV-HD induced an immune response (as assessed by hemagglutination
      inhibition [HAI] geometric mean titers [GMTs] and seroconversion rates) that was superior to
      responses induced by QIV-SD for the 4 virus strains at 28 days post-vaccination in all
      participants.

      Secondary Objective:

        -  To describe the immune response induced by QIV-HD and QIV-SD by HAI measurement method
           in all participants.

        -  To describe the safety profile of all participants in each study group.
    

Eligibility criteria:

        Inclusion criteria :

          -  Aged greater than or equal to (>=) 60 years on the day of inclusion.

          -  Able to attend all scheduled visits and complied with all study procedures.

        Exclusion criteria:

          -  Participation at the time of study enrollment (or in the 4 weeks preceding the study
             vaccination) or planned participation during the present study period in another
             clinical study investigating a vaccine, drug, medical device, or medical procedure.

          -  Receipt of any vaccination with live vaccines within the past 27 days preceding the
             study vaccination or any vaccination with inactivated vaccines within the past 6 days
             preceding the study vaccination, or planned receipt of any vaccine prior to Visit 02.

          -  Previous vaccination against influenza (in the preceding 6 months) with either the
             study vaccine or another vaccine.

          -  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 eggs, chicken proteins, or any of the vaccine
             components, or history of a life-threatening reaction to the vaccine used in the study
             or to a vaccine containing any of the same substances.

          -  Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on
             Investigator's judgment.

          -  Alcohol or substance abuse that, in the opinion of the Investigator might interfere
             with the study conduct or completion.

          -  Chronic illness that, in the opinion of the Investigator, was at a stage where it
             might interfere with study conduct or completion.

          -  Identified as an Investigator or employee of the Investigator or study center with
             direct involvement in the proposed study, or identified as an immediate family member
             (i.e.,parent, spouse, natural or adopted child) of the Investigator or employee with
             direct involvement in the proposed study.

          -  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
             participants who have a history of neoplastic disease and have been disease free for
             >=5 years).

          -  Moderate or severe acute illness/infection (according to Investigator judgment) on the
             day of vaccination or febrile illness (temperature >=37.5 degree Celsius). A
             prospective participant was not be included in the study until the condition had
             resolved or the febrile event had subsided.

          -  History of convulsions.

          -  Any condition that in the opinion of the Investigator could interfere with the
             evaluation of the vaccine.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.