Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza Virus Vaccine, Fluzone®; Influenza Virus Vaccine, Fluzone®
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: 173.0
Sex: All
Minimum age: 11 Months
Maximum age: 14 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fluzone®; Influenza; Influenza virus infection; Influenza vaccine

Summary:

      To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone
      vaccine (2006-2007 formulation).
    

Eligibility criteria:

        Inclusion Criteria :

          -  Previously enrolled in study GRC28 and received 2 vaccinations of the assigned lot.

          -  Considered to be in good health on the basis of reported medical history and
             history-directed physical evaluation.

          -  Available for the duration of the study.

          -  Parent/legal representative willing and able to provide informed consent.

          -  Parent/legal representative able to attend all scheduled visits and comply with all
             trial procedures.

          -  Parent/legal representative willing to permit venipuncture for purposes of collecting
             a blood sample.

        Exclusion Criteria :

          -  Receipt of any vaccine within the past 7 days (subjects may be deferred until after
             the seven days has passed.)

          -  Reported allergy to egg proteins, chicken proteins or any other constituent of the
             vaccine.

          -  Ever received any influenza vaccine, other than at Visits 1 and 2 of study GRC28, or
             known to have ever been diagnosed with laboratory-confirmed influenza.

          -  An acute illness with fever (rectal temperature ≥ 100.4°F [38.0°C]) in the 72 hours
             preceding enrollment in the trial (defer enrollment).

          -  Known bleeding disorder.

          -  Participation in any other interventional clinical trial within 30 days prior to
             enrollment, or planned participation in another interventional clinical trial prior 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 that, in the opinion of the
             investigator, could interfere with trial conduct or completion.

          -  Known Human Immunodeficiency Virus (HIV)-positive mother or Hepatitis B surface
             antigen (HBsAg)-positive mother.

          -  Known HIV, Hepatitis B, or Hepatitis C infection.

          -  Administration of immune globulin or other blood products within the last three
             months, or injected or oral corticosteroids or other immunomodulator therapy within
             six weeks of the study vaccine. Individuals on a tapering dose schedule of oral
             steroids lasting < 7 days may be included in the trial as long as they have not
             received more than one course within the last two weeks prior to enrollment.

          -  Prior personal history of Guillain-Barré syndrome.

          -  Any condition that, in the opinion of the investigator, would pose a health risk to
             the subject or interfere with the evaluation of the vaccine.