Influenza Vaccine Revaccination in Ambulatory Elderly Subjects
NCT ID: NCT00775450
Last Updated: 2013-12-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
807 participants
INTERVENTIONAL
2008-10-31
2009-07-31
Brief Summary
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Primary Objective:
To describe the safety profile for all subjects.
Secondary Objective:
To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1a: Fluzone ID After Fluzone ID
Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
Group 1b: Fluzone IM After Fluzone ID
Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
Group 2a: Fluzone IM After Fluzone IM
Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
Group 2b: Fluzone ID After Fluzone IM
Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
Group 3: Fluzone HD After Fluzone HD
Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
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
Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Enrolled in and completed study FID29 and received the correct vaccine 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
* Subject is medically stable.
Exclusion Criteria
* 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
* 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 (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 intramuscular (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, (except 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).
* Personal or family history of Guillain-Barré Syndrome.
65 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 Monitor
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Hoover, Alabama, United States
Mobile, Alabama, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Fountain Valley, California, United States
San Diego, California, United States
Milford, Connecticut, United States
Pembroke Pines, Florida, United States
Pinellas Park, Florida, United States
Chicago, Illinois, United States
Wichita, Kansas, United States
Kansas City, Missouri, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Cary, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Bensalem, Pennsylvania, United States
Warwick, Rhode Island, United States
Mt. Pleasant, South Carolina, United States
Fort Worth, Texas, United States
Galveston, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Marshfield, Wisconsin, United States
Countries
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Related Links
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Related Info
Other Identifiers
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FID21
Identifier Type: -
Identifier Source: org_study_id