Study of Safety and Immunogenicity of Fluzone® in Healthy Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza Vaccine 2004-2005 Paediatric Formulation; Influenza Vaccine 2004-2005 Paediatric Formulation
Intervention description: 0.25 mL (Day 0 and Day 28), Intramuscular; 0.25 mL (Day 0 and Day 28), Intramuscular
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: 35 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Fluzone® vaccine; Infants; Toddlers

Summary:

      To describe the safety of the 2004-2005 pediatric formulation of the inactivated,
      split-virion influenza vaccine Fluzone®, 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 2004-2005 inactivated, split-virion influenza vaccine
      Fluzone®, 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 to < 36 months.

          -  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/guardian is willing and able to provide informed consent.

          -  Parent/guardian is willing and able to meet protocol requirements.

        Exclusion Criteria :

          -  Reported allergy to egg proteins, chicken proteins, or any other constituent of the
             vaccine.

          -  Previous history of influenza vaccination or 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 (defer enrollment).

          -  Clinically significant findings in vital signs or review of systems (investigator
             judgment; defer or exclude).

          -  Participation in any other 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.

          -  Any vaccination in the 14 days preceding enrollment in the study or scheduled between
             Visit 1 and Visit 3.