Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.

Completed · Phase 4

Conditions studied: Influenza

In brief

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

Key facts

Study ID

NCT00390884

Run by

Sanofi Pasteur, a Sanofi Company

People needed

173

Starts

2006-10-01

Expected to finish

2008-09-01

Last updated by the study team

2016-04-14

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Layton, Utah, United States
• Study site — Pleasant Grove, Utah, United States
• Study site — Provo, Utah, United States
• Study site — Salt Lake City, Utah, United States
• Study site — South Jordan, Utah, United States

Full record on ClinicalTrials.gov

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