Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®
Condition: Influenza; Orthomyxoviridae Infections
MeSH terms: Influenza, Human; Orthomyxoviridae Infections
Intervention: Influenza Virus Vaccine No Preservative: Pediatric Dose; Influenza Virus Vaccine No Preservative: Pediatric Dose
Intervention description: 0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months); 0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 6 Months
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Orthomyxoviruses; Orthomyxoviridae Infections; Influenza vaccine

Summary:

      Primary Objective:

      To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from
      healthy children receiving the 2008-2009 formulation of the inactivated, split-virion
      influenza vaccine Fluzone® for further study.

      Observational Objectives:

      To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine,
      administered in a one- or two-dose schedule in accordance with Advisory Committee on
      Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age.

      To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine,
      administered in a one- or two-dose schedule in accordance with ACIP recommendations, in
      children ≥ 6 months to < 5 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is ≥ 6 months to < 5 years of age.

          -  Participant is considered to be in good health on the basis of reported medical
             history and a limited history-directed physical examination.

          -  Parent/legal acceptable representative is willing and able to bring the subject to the
             scheduled visits and to comply with the study procedures during the entire duration of
             the study.

          -  Parent/legal acceptable representative is willing and able to provide informed
             consent.

          -  Subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
             (5.5 lbs).

        Exclusion Criteria:

          -  Reported allergy to egg proteins, chicken proteins, or any other constituent of the
             vaccine.

          -  History of severe adverse event to any influenza vaccine.

          -  Laboratory-confirmed influenza infection or vaccination against influenza in the 6
             months preceding enrollment in the study.

          -  Any vaccination scheduled between Visit 1 and Visit 2.

          -  Planned participation in any other interventional clinical trial during participation
             in the study.

          -  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 Human immunodeficiency virus (HIV)-positive mother.

          -  Prior personal history of Guillain-Barré syndrome.

          -  Any condition which, in the opinion of the Investigator, would pose a health risk to
             the subject or interfere with the evaluation of the vaccine.

          -  Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.