Study of a Single Dose or Two Doses of a Quadrivalent Influenza Vaccine in Subjects Aged 6 Months or Older in India
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative; Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative; Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative; Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservative
Intervention description: 0.25 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 400.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Quadrivalent Inactivated Influenza Vaccine (QIV)

Summary:

      The aim of the study was to generate immunogenicity and safety data in the whole population
      to support registration of the Quadrivalent Influenza Vaccine (QIV) in India:

      Primary objective:

        -  To describe in each age group the immune response induced by a single injection
           (participants aged >9 years) or 2 injections (participants aged 6 months to 8 years) of
           QIV.

      Secondary objective:

        -  To describe in each age group the safety profile of QIV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 6 months or older on the day of inclusion

          -  For participants aged 6 to 35 months only: born at full term of pregnancy (>=37 weeks)
             or birth weight >=2.5 kg or both

          -  Informed consent form had been signed and dated by the participants / participants'
             parent(s) or another legally acceptable representative and by an independent witness,
             if required by local regulations. For participants aged 7 to 17 years of age, assent
             form has been signed and dated by the participants

          -  Participants / participants' parent/legally acceptable representative were able to
             attend all scheduled visits and to comply with all trial procedures

        Exclusion Criteria:

          -  For participants aged 9 years or older only: participant was pregnant, or lactating,
             or of childbearing potential (to be considered of non-childbearing potential, a female
             must be pre-menarche or 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 4 weeks after vaccination)

          -  Participation at the time of study enrollment (or in the 4 weeks preceding the first
             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 preceding the first trial vaccination or planned
             receipt of any vaccine in the 4 weeks following any trial vaccination (except Oral
             Poliomyelitis Vaccine (OPV) received during national immunization days)

          -  For participants aged 9 years or older only: previous vaccination against influenza
             (in the previous 9 months) with any influenza vaccine

          -  For participants aged 6 months to 8 years only: previous priming with any influenza
             vaccine (i.e., participants who received 2 doses for at least 1 previous influenza
             season)

          -  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)

          -  Self-reported history of seropositivity for Human Immunodeficiency Virus (HIV),
             Hepatitis B, or Hepatitis C, after questioning

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccine used in the trial or to a vaccine containing
             any of the same substances

          -  Self-reported thrombocytopenia or as reported by the parent/legally acceptable
             representative, contraindicating intramuscular vaccination

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating IM vaccination

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily

          -  For participants aged 9 years or older only: current alcohol abuse or drug addiction

          -  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 (axillary temperature >=38.0 degree Celsius). A
             prospective participants should not be included in the study until the condition had
             resolved or the febrile event has 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
             (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
             direct involvement in the proposed study