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 Taiwanese Adults 65 Years of Age and Older
Condition: Influenza (Healthy Volunteers)
MeSH terms: Influenza, Human
Intervention: High-Dose Quadrivalent Influenza Vaccine; Standard-Dose Quadrivalent Influenza Vaccine
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: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The study was modified double-blind. The designated vaccine prepare(s)/administrator(s) would be unblinded given that the QIV-HD and QIV-SD vaccines had different dose volumes. Neither the participant nor the investigator nor the study staff in charge of vaccination was aware of which vaccine was administered (the syringes was masked to maintained the blinding of the participants and other members of the clinical site). The unblinded designated vaccine preparer(s)/administrator(s) was not involved in any of the blinded study assessments (eg, immunogenicity, safety).
Enrollment: 165.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza

Summary:

      Primary Objective:

      Immunogenicity: To describe the immune response induced by high-dose quadrivalent influenza
      vaccine (QIV-HD) and AdimFlu-S (QIS) by hemagglutinin inhibition (HAI) measurement method in
      all participants.

      Safety: To describe the safety profile of all participants in each study groups.
    

Eligibility criteria:

        Inclusion criteria :

          -  65 years and older 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 study period in another clinical
             study investigating a vaccine, drug, medical device, or medical procedure.

          -  Receipt of any vaccine in the 4 weeks (28 days) preceding the study vaccination or
             planned receipt of any vaccine prior to Visit 2.

          -  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 any of the vaccine components, or history of a
             life-threatening reaction to the vaccine(s) used in the study or to a vaccine
             containing any of the same substances.

          -  Thrombocytopenia, bleeding disorder, or receipt of anticoagulants that based on
             Investigator's judgment contraindicate intramuscular vaccination.

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

          -  Alcohol, prescription drug, 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 trial conduct or completion.

          -  Moderate or severe acute illness/infection (according to investigator judgment) on the
             day of vaccination or febrile illness (temperature greater than or equal to [>=] 38.0
             degree Celsius). A prospective participant should not be included in the study until
             the condition has resolved or the febrile event has subsided.

          -  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).

          -  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) of the Investigator or employee with direct involvement in the
             proposed study.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.