Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone Quadrivalent vaccine, No Preservative; Fluzone Quadrivalent vaccine, No Preservative
Intervention description: 0.25-mL (Pediatric Dose), Intramuscular (2016-2017 formulation); 0.5-mL, Intramuscular (2016-2017 formulation)
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1950.0
Sex: All
Minimum age: 6 Months
Maximum age: 35 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Influenza virus vaccine; Fluzone® Quadrivalent Influenza Vaccine (No Preservative)

Summary:

      The aim of the study was to describe the safety and immunogenicity of a 0.5-mL dose (15 μg
      hemagglutinin [HA] per strain) of Fluzone Quadrivalent vaccine in children 6 to <36 months of
      age.

      Primary objective:

        -  To compare the rate of any fever (temperature ≥100.4 degrees Fahrenheit [38.0 degrees
           Celsius) following a 0.5-mL dose of Fluzone Quadrivalent vaccine to that following a
           0.25-mL dose of Fluzone Quadrivalent vaccine during the 7 days after either vaccination
           (Dose 1 and Dose 2 combined) in participants 6 to < 36 months of age.

      Secondary objective:

        -  To compare antibody responses induced by a 0.5-mL dose of Fluzone Quadrivalent vaccine
           to those induced by a 0.25-mL dose of Fluzone Quadrivalent vaccine as assessed by
           geometric mean titer (GMT) ratios and seroconversion rate differences after the final
           vaccination in participants 6 to < 36 months of age.

      Other objectives:

        -  To describe the safety of 2 different dose levels of the 2016-2017 formulation of
           Fluzone Quadrivalent vaccine in participants 6 to < 36 months of age.

        -  To describe the immunogenicity of 2 different dose levels of the 2016-2017 formulation
           of Fluzone Quadrivalent vaccine in participants 6 months to < 36 months of age.

        -  To submit available sera from approximately 30 participants to the Center for Biologics
           Evaluation and Research for further analysis by the World Health Organization, the
           Centers for Disease Control and Prevention, and the FDA to support formulation
           recommendations for subsequent influenza vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 6 to < 36 months of age on the day of first study vaccination (study product
             administration).

          -  Born at full term of pregnancy (≥37 weeks) and/or with a birth weight ≥2.5 kg. Note:
             This inclusion criterion only applies to participants 6 to <12 months of age on the
             day of the first study visit.

          -  Informed consent form has been signed and dated by the parent(s) or guardian(s).

          -  Participant and parent/guardian are able to attend all scheduled visits and to comply
             with all trial procedures.

        Exclusion Criteria:

          -  Participation at the time of study enrollment (or in the 30 days 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 30 days preceding the first trial vaccination, or
             planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of
             influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine.

          -  Previous vaccination against influenza (in the 2016-2017 season) 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 vaccine used in the trial or to a vaccine containing
             any of the same substances.

          -  Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at
             the discretion of the Investigator.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination.

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

          -  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 planned vaccination or febrile illness (temperature ≥100.4 degrees Fahrenheit
             [38.0 degrees Celsius]). A prospective participant should not be included in the study
             until the condition has resolved or the febrile event has subsided.

          -  Identified as a natural or adopted child of either the Investigator or an employee
             with direct involvement in the proposed study.

          -  History of serious adverse reactions to any influenza vaccine.

          -  Personal history of Guillain-Barré syndrome.

          -  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 clinically significant developmental delay (at the discretion of
             the Investigator), neurologic disorder, or seizure disorder.

          -  Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.