Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza Virus Vaccine (Fluzone®); Influenza Virus Vaccine (Fluzone®)
Intervention description: 0.25 mL, Intramuscular (Day 0 and Day 28); 0.25 mL, Intramuscular (Day 0)
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: 30.0
Sex: All
Minimum age: 6 Months
Maximum age: 36 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fluzone®; Influenza Virus Vaccine

Summary:

      To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for
      Disease Control and Prevention (CDC), and the World Health Organization (WHO) for
      characterization of circulating influenza strains.

      Observational Objectives:

      To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, given in
      the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to <
      36 months.

      To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine,
      administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥
      6 months to < 36 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is aged ≥ 6 months (24 weeks) to < 36 months (3rd birthday).

          -  Participant is considered to be in good health on the basis of reported medical
             history and limited physical examination.

          -  Participant is available for the duration of the study.

          -  Parent/legal acceptable representative is willing and able to provide informed
             consent.

          -  Parent/legal acceptable representative is willing and able to meet protocol
             requirements.

          -  Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg.

        Exclusion Criteria:

          -  Reported allergy to egg proteins, chicken proteins, or any other constituent of the
             vaccine.

          -  Documented history of influenza infection.

          -  An acute illness with or without fever (temperature ≥ 100.4 °F, rectal) in the 72
             hours preceding enrollment in the trial (Enrollment may be deferred).

          -  Clinically significant findings in vital signs or review of systems (investigator
             judgment; defer or exclude).

          -  Participation in any other interventional clinical trial within 30 days prior to
             enrollment up to termination of the subject's 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 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.