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 Europeans Adults 60 Years of Age and Older
Condition: Influenza Immunization; Healthy Volunteers
MeSH terms: Influenza, Human
Intervention: Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD); High-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulation
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: IM
Intervention MeSH terms: Hemagglutinins; Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants randomized in each group were stratified by age (60 to 64 years of age; 65 years of age and older).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Modified double-blind: the participant and the Investigators remained unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member administered the appropriate vaccine but were not involved in the immunogenicity and safety evaluations.
Enrollment: 1539.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Primary Objective:

      To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune
      response that is superior to the responses induced by standard-dose quadrivalent influenza
      vaccine (QIV-SD) for all 4 virus strains 28 days post-vaccination in participants 60 to 64
      years of age and in participants 65 years of age and older.

      Secondary Objective:

        -  Immunogenicity: To further describe the immune response induced by QIV-HD and QIV-SD in
           all participants by age group, in pooled age groups, and by vaccine group (QIV-HD;
           QIV-SD).

        -  Safety: To describe the safety profile of all participants by age group, in pooled age
           groups, and by vaccine group (QIV-HD; QIV-SD).
    

Eligibility criteria:

        Inclusion criteria :

          -  Sixty years of age and older on the day of inclusion.

          -  Able to attend all scheduled visits and complied with all trial procedures.

        Exclusion criteria:

          -  Participant was pregnant, or lactating, or of childbearing potential and did not used
             an effective method of contraception or abstinence from at least 4 weeks prior to
             vaccination until at least 4 weeks after vaccination. To be considered of
             non-childbearing potential, a female must be post-menopausal for at least 1 year, or
             surgically sterile.

          -  Participation at the time of study enrollment (or in the 4 weeks [28 days] 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 02.

          -  Previous vaccination against influenza (in the previous 6 months) with either the
             trial 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 any of the vaccine components, or history of a
             life-threatening reaction to the vaccines 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 judgement.

          -  Alcohol or 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

          -  Moderate or severe acute illness/infection (according to Investigator judgment) or
             febrile illness (temperature greater than or equal to (>=) 38.0 degree Celsius) on the
             day of vaccination. A prospective participant should not be included in the study
             until the condition had resolved or the febrile event had subsided.

          -  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
             (ie, 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 was stable at the time of vaccination in the absence of therapy and
             participants who had a history of neoplastic disease and had been disease free for >=
             5 years)

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.