Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: QIV-HD; Licensed TIV-HD1; Investigational TIV-HD2
Intervention description: 0.7 mL-dose was administered intramuscularly (IM) into the upper arm area.; 0.5 mL-dose was administered IM into the upper arm area.; 0.5 mL-dose was administered IM into the upper arm area.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: QHD00013 was a phase III, randomized, modified double-blind, active-controlled, multi-center trial.
Masking: Double (Participant, Outcomes Assessor)
Masking description: QHD00013 was a modified double-blind trial with an unblinded administrator used at each trial site. The administrator was not involved in any of the blinded study assessments (e.g., safety).
Enrollment: 2670.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza

Summary:

      This randomized, modified double-blind, active-controlled, multi-center trial assessed the
      safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared
      to either the licensed or investigational high-dose trivalent influenza vaccine (TIV-HD) in
      adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged >= 65 years on the day of inclusion.

          -  Informed consent form had 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.

          -  Previous vaccination against influenza (in the preceding 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 judgment.

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

          -  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.

          -  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, natural or adopted child) 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
             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 >= 38.0°C [>= 100.4°F]). A
             prospective participant should not be included in the trial until the condition has
             resolved or the febrile event had subsided.