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