Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Given by Intramuscular Route in Subjects Aged 18 to 60 Years
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016; Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation
Intervention description: 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: Single (Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Quadrivalent influenza vaccine; Trivalent influenza vaccine

Summary:

      The aim of the trial is to evaluate immunogenicity and safety of the quadrivalent influenza
      vaccine (QIV) and the trivalent influenza vaccine (TIV) (split-virion inactivated) Northern
      Hemisphere (NH) 2015 2016 seasonal formulations, in subjects aged 18 to 60 years in the
      Republic of Korea for the registration of the QIV by the Ministry of Food and Drug Safety.

      Objectives:

        -  To evaluate the immunogenicity of QIV and TIV (split-virion, inactivated) NH 2015-2016
           seasonal formulations. The compliance, in terms of immunogenicity, of the QIV NH
           2015-2016 formulation, with the requirements of the Committee for Medicinal Products for
           Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 will be assessed.

        -  To evaluate the safety profile of QIV and TIV (split-virion, inactivated) NH 2015-2016
           seasonal formulations
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 to 60 years on the day of inclusion

          -  Subjects aged 18 years: Assent form has been signed and dated by the subject or by an
             independent witness, and informed consent form has been signed and dated by at least
             one parent or another legally acceptable representative or by an independent witness
             Subjects aged 19 to 60 years: Informed consent form has been signed and dated by the
             subject or by an independent witness

          -  Subject and parent/legally acceptable representative (if applicable) are able to
             attend all scheduled visits and to comply with all trial procedures

        Exclusion Criteria:

          -  Subject is 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 3 weeks after
             vaccination)

          -  Participation at the time of study 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 preceding the trial vaccination or planned
             receipt of any vaccine until the second visit, 3 weeks following the trial vaccination

          -  Vaccination against influenza if administered in the context of a clinical trial or a
             flu vaccination campaign or self-reported history of influenza infection
             (influenza-like illness) in the previous 6 months

          -  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 history of seropositivity for Human Immunodeficiency Virus (HIV) or Hepatitis C

          -  Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and
             octoxynol-9, or to any of the vaccine components, or history of a life-threatening
             reaction to the vaccines used in the study or to a vaccine containing any of the same
             substances

          -  Known or suspected thrombocytopenia, contraindicating intramuscular vaccination, based
             on Investigator's judgment

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination, based on Investigator's judgment

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily

          -  Current alcohol abuse or drug addiction

          -  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) on the
             day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject
             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 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.