Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM
NCT ID: NCT01011049
Last Updated: 2016-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1250 participants
INTERVENTIONAL
2009-09-30
2010-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1: Fluzone ID After Fluzone ID
Participants will receive Fluzone intradermal (ID) following Fluzone ID in Study FID31
Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
Group 2: Fluzone IM After Fluzone ID
Participants will receive Fluzone intramuscular (IM) following Fluzone ID in Study FID31
Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
Group 3: Fluzone IM After Fluzone IM
Participants will receive Fluzone intramuscular (IM) following Fluzone IM in Study FID31
Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
Group 4: Fluzone ID After Fluzone IM
Participants will receive Fluzone intradermal (ID) following Fluzone intramuscular (IM) in Study FID31
Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
Interventions
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Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
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.
18 Years
64 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Hoover, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Tempe, Arizona, United States
Tucson, Arizona, United States
Fountain Valley, California, United States
San Diego, California, United States
Milford, Connecticut, United States
Melbourne, Florida, United States
Pembroke Pines, Florida, United States
Pinellas Park, Florida, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Madisonville, Kentucky, United States
Rockville, Maryland, United States
Kansas City, Missouri, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
Binghamton, New York, United States
Endwell, New York, United States
Rochester, New York, United States
Rochester, New York, United States
Cary, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Allentown, Pennsylvania, United States
Bensalem, Pennsylvania, United States
Warwick, Rhode Island, United States
Mt. Pleasant, South Carolina, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Fort Worth, Texas, United States
Fort Worth, Texas, United States
San Angelo, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Marshfield, Wisconsin, United States
San Juan, , Puerto Rico
Countries
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Related Links
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Related Info
Other Identifiers
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UTN: U1111-1111-5095
Identifier Type: OTHER
Identifier Source: secondary_id
FID33
Identifier Type: -
Identifier Source: org_study_id
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