A Study of Influenza Virus Vaccines in Children and Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: 2009-2010 Trivalent Influenza Virus Vaccine; 2008-2009 Trivalent Influenza Virus Vaccine; Quadrivalent Influenza Virus Vaccine
Intervention description: 0.25 mL, Intramuscular (participants at 6 to 35 months of age - Pediatric Dose); Others 0.5 mL, Intramuscular.; 0.25 mL, Intramuscular; 0.5 mL, Intramuscular.; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 600.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Trivalent Influenza Virus Vaccine; Quadrivalent Influenza Virus Vaccine

Summary:

      The purpose of this study is to describe the immunogenicity of the prototype Quadrivalent
      Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the
      2008-2009 TIV among children and adults.

      Primary Objective:

      To describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared
      with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among adults.

      Observational Objectives:

        -  To describe the safety of the 2009-2010 TIV among subjects ≥6 months to <5 years, 18-60
           years, and ≥ 61 years of age, and to describe the safety of 2008-2009 TIV and prototype
           QIV Fluzone® vaccines among subjects 18-60 years and ≥ 61 years of age.

        -  To describe the immunogenicity of the 2009-2010 TIV vaccine among subjects ≥6 months to
           <5 years, 18-60 years, and ≥61 years of age, and to describe the immunogenicity of
           2008-2009 TIV and prototype QIV vaccines among subjects 18-60 years and ≥61 years of
           age.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Subject is ≥ 6 months to < 5 years of age or 18 years of age or older on the day of
             inclusion.

          -  Parent/legal guardian (if the subject is ≥ 6 months to < 5 years of age) or adult
             subject (if 18 years of age or older) is willing and able to attend scheduled visits
             and to comply with the study procedures during the entire duration of the study.

          -  Subject in reasonably good health as assessed by the Investigator.

          -  Parent/legal guardian (if the subject is ≥ 6 months to < 5 years of age) or adult
             subject (if 18 years of age or older) is willing and able to give informed consent.

          -  For subjects ≥ 6 months to < 5 years of age: subject was born at full term of
             pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).

          -  For a woman, inability to bear a child or negative serum/urine pregnancy test, if
             applicable.

        Exclusion Criteria :

        For all subjects:

          -  History of allergy to egg proteins, chicken proteins, or one of the constituents of
             the vaccine, such as thimerosal or formaldehyde.

          -  History of serious adverse reaction to any influenza vaccine.

          -  Laboratory-confirmed influenza infection or vaccination against influenza in the six
             months preceding enrollment in the study.

          -  Any vaccination scheduled between Visit 1 and Visit 2 or Visit 3.

          -  Participation in any other interventional drug or vaccine trial during participation
             in this study.

          -  Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.

          -  Any condition that in the opinion of the Investigator would pose a health risk to the
             subject if enrolled or could interfere with the evaluation of the vaccine.

          -  Prior personal history of Guillain-Barré syndrome.

        For subjects > 6 months to < 5 years of age:

          -  Known or suspected impairment of immunologic function or receipt of immunosuppressive
             therapy or immunoglobulin since birth.

          -  Personal or immediate family history of congenital immune deficiency.

          -  Developmental delay, neurologic disorder, or seizure disorder.

          -  Chronic medical, congenital, or developmental disorder.

          -  Known HIV-positive mother.

        For subjects 18 years of age and older:

          -  Immunocompromising condition; immunosuppressive therapy (including systemic steroid
             use for two weeks or more); cancer chemotherapy or radiation therapy at the time of
             enrollment, planned during the period of this study, or at any time within the past
             six months.

          -  Diabetes mellitus requiring pharmacological control.

          -  Person deprived of freedom by an administrative or court order (having legal or
             medical guardian).

          -  For women of childbearing potential, a positive urine pregnancy test, breast feeding,
             or not using a medically approved and reliable form of contraception (oral
             contraceptives or double barrier method) for the duration of the trial.

          -  Current use of alcohol or recreational drugs that may interfere with the subject's
             ability to comply with trial procedures.

          -  Any subject with the following conditions is not eligible for enrollment. However, the
             subject may be enrolled subsequently if the condition has resolved and enrollment is
             still ongoing and the subject meets all other inclusion/exclusion criteria:

               -  An acute illness with or without fever in the 72 hours preceding enrollment in
                  the trial.

               -  Clinically significant findings in vital signs or review of systems (Investigator
                  judgment).

               -  Received any vaccinations within the preceding 14 days.

               -  Participation in any other interventional clinical trial within 30 days prior to
                  enrollment.

               -  Receipt of blood or blood products within the three months preceding enrollment
                  in the study.