Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: 2007-2008 Influenza Virus Vaccine; 2007-2008 Influenza Virus Vaccine
Intervention description: 0.25 mL, Intramuscular; 0.25 mL, 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: 34.0
Sex: All
Minimum age: 6 Months
Maximum age: 35 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza Vaccine; Influenza Virus; Orthomyxoviridae Infections; Fluzone®

Summary:

      To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from
      healthy children receiving the 2007-2008 formulation of the inactivated, split-virion
      influenza vaccine Fluzone® for further study.
    

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 or planned 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.

          -  Received any vaccinations within the preceding 14 days (enrollment may be deferred).