Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone Quadrivalent Influenza Vaccine
Intervention description: 0.5-mL, Intramuscular, SH 2015 formulation
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were enrolled in two age groups: participants aged 18 to 60 years and participants aged 61 years or older.
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Influenza virus vaccine; Fluzone® Quadrivalent Influenza Vaccine (No Preservative)

Summary:

      The aim of the study was to assess the immunogenicity and safety of Fluzone Quadrivalent
      influenza vaccine Southern Hemisphere (SH) 2015 formulation in participants aged 18 to 60
      years as well as in participants 61 years or older.

      The objectives were:

        -  To evaluate the compliance, in terms of immunogenicity, of the Fluzone Quadrivalent
           influenza vaccine SH 2015 formulation with the requirements of the European Medicines
           Agency (EMA) Note for guidance (NfG) CPMP/BWP/214/96

        -  To describe the immunogenicity of the Fluzone Quadrivalent influenza vaccine SH 2015
           formulation

        -  To describe the safety of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants were >= 18 years of age 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:

          -  History of serious adverse reaction to any influenza vaccine.

          -  Receipt of any vaccine within 30 days before receiving study vaccine, or plans to
             receive another vaccine before Visit 2.

          -  Participation in another interventional clinical trial investigating a vaccine, drug,
             medical device, or medical procedure in the 30 days preceding the first study
             vaccination or during the course of the study.

          -  Self-reported thrombocytopenia, which may be a contraindication for intramuscular
             vaccination, at the discretion of the Investigator.

          -  Vaccination against influenza in the previous 12 months if administered in the context
             of a clinical trial or a flu vaccination campaign.

          -  Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine
             components, or a history of a life-threatening reaction to the vaccine or to a vaccine
             containing any of the same substances (the complete list of vaccine components is
             included in the Prescribing Information) .

          -  Receipt of immune globulins, blood, or blood-derived products in the past 3 months.

          -  Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,
             which may be a contraindication for intramuscular vaccination, at the discretion of
             the Investigator.

          -  Participant was pregnant, or lactating, or of childbearing potential (to be considered
             of non-childbearing potential, a female must be post-menopausal for at least 1 year,
             surgically sterile, or using an effective method of contraception or abstinence from
             at least 4 weeks prior to vaccination and until at least 3 weeks after vaccination).

          -  Any condition that in the opinion of the Investigator would pose a health risk to the
             participant if enrolled or could interfere with the evaluation of the vaccine.

          -  Personal history of Guillain-Barré syndrome.

          -  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).

          -  Chronic illness that, in the opinion of the Investigator, is at a stage where it might
             interfere with trial conduct or completion .

          -  Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis
             C, as reported by the participant. (No screening procedures were implemented.)

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

          -  Current alcohol or drug addiction that, in the opinion of the Investigator, might
             interfere with the ability to comply with trial procedures.

          -  Moderate or severe acute illness/infection (according to Investigator judgment) or
             febrile illness (temperature ≥ 38°C) on the day of vaccination. A prospective
             participant should not be included in the study until the condition has resolved or
             the febrile event has subsided.

          -  Identified as an Investigator or employee of an 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 an Investigator or employee with
             direct involvement in the proposed study.