Trial to Collect Safety Data and Sera for Immunogenicity Testing
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza Virus Vaccine (Fluzone®); Influenza Virus Vaccine (Fluzone®)
Intervention description: 0.25 mL, Intramuscular (infant/children dose); 0.25 mL, Intramuscular (infant/children dose)
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: 31.0
Sex: All
Minimum age: 6 Months
Maximum age: 36 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Influenza Virus Vaccine; Fluzone®

Summary:

      To provide Centers for Biologics Evaluation and Research (CBER) with sera collected from
      healthy children receiving the 2006-2007 formulation of the inactivated, split-virion
      influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA),
      Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).
    

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 (5.5 lbs).

        Exclusion Criteria:

          -  Reported allergy to egg proteins, chicken proteins, or any other constituent of the
             vaccine.

          -  An acute illness with or without fever (For infants/toddlers: temperature

             ≥ 100.4 °F rectal; For children: temperature ≥ 99.5 °F oral/axillary) 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 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.