Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM

Completed · Phase 2

Conditions studied: Influenza

In brief

The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine. Primary Objective: * To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants. Secondary Objective: * To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.

Key facts

Study ID

NCT01011049

Run by

Sanofi Pasteur, a Sanofi Company

People needed

1250

Starts

2009-09-01

Expected to finish

2010-10-01

Last updated by the study team

2016-04-14

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged 18 to 64 years on the day of vaccination in study FID33
• Enrolled in and completed study FID31 (NCT 00772109) and received the correct vaccine (Fluzone ID or Fluzone® IM) for the group to which they were randomized
• Informed consent form signed and dated
• Able to attend all scheduled visits and to comply with all trial procedures
• For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination

You may not qualify if…

• Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
• For a woman of child-bearing potential: known pregnancy or positive serum/urine pregnancy test
• Breast-feeding woman
• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination
• Planned participation in another clinical trial during the present trial period (observational trials will be allowed)
• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
• Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
• Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
• Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
• Receipt of any vaccination in the 4 weeks preceding the trial vaccination
• Planned receipt of any vaccine in the 4 weeks following the trial vaccination
• Known human immunodeficiency virus (HIV), hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity.
• Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine
• Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
• Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
• Neoplastic disease or any hematologic malignancy, (those who have localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease free for ≥ 5 years will not be excluded).
• Personal or family history of Guillain-Barré Syndrome
• Temporary Exclusion Criteria:
• A prospective subject should not be included in the study until the following conditions and/or symptoms are resolved:
• Febrile illness (temperature ≥ 37.5°C [or ≥ 99.5°F]) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
• Signs and symptoms of an acute infectious respiratory illness.

Where it is running

• Study site — Hoover, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Chandler, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Fountain Valley, California, United States
• Study site — San Diego, California, United States
• Study site — Milford, Connecticut, United States
• Study site — Melbourne, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Pinellas Park, Florida, United States
• Study site — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Wichita, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Madisonville, Kentucky, United States
• Study site — Rockville, Maryland, United States
• Study site — Kansas City, Missouri, United States
• Study site — Springfield, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Binghamton, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.