Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
NCT ID: NCT00845429
Last Updated: 2012-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
729 participants
INTERVENTIONAL
2007-10-31
2008-11-30
Brief Summary
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To describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.
Secondary Objective:
To describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.
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
SINGLE
Study Groups
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Group 1: Standard-dose Cell-based Influenza Vaccine
Participants will receive a single dose of standard-dose cell-based influenza virus vaccine.
Influenza virus vaccine - cell based (2007-2008 Formulation)
0.5 mL, Intramuscular
Group 2: High-dose Cell-based Influenza Vaccine
Participants will receive a single dose of high-dose cell-based influenza virus vaccine.
Influenza virus vaccine - cell-based (2007-2008 Formulation)
1.0 mL, Intramuscular
Group 3: Licensed Fluzone® Influenza Vaccine
Participants will receive a single dose of licensed Fluzone® influenza vaccine.
Influenza virus vaccine (2007-2008 Formulation)
0.5 mL, Intramuscular
Interventions
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Influenza virus vaccine - cell based (2007-2008 Formulation)
0.5 mL, Intramuscular
Influenza virus vaccine - cell-based (2007-2008 Formulation)
1.0 mL, Intramuscular
Influenza virus vaccine (2007-2008 Formulation)
0.5 mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent form signed
* Able to attend all scheduled visits and to comply with all trial procedures
* For a woman of childbearing potential: a negative urine pregnancy test and documented use of an effective method of contraception or abstinence for at least four weeks pre vaccination and up until three weeks post-vaccination
Exclusion Criteria
* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Prior participation in the Phase I trial of FLU INTERPAN (PER.C6) vaccine (study GCE01).
* Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
* Systemic corticosteroid therapy as except the use of topical or inhalant corticosteroids
* Systemic hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
* Chronic illness at a stage that could interfere with trial conduct or completion (chronic illness may include, but is not limited to, cardiac, renal or auto-immune disorders, or diabetes).
* Receipt of blood or blood-derived products in the 3 months preceding vaccination.
* Receipt of any vaccination in the 4 weeks preceding vaccination, or planned receipt of any vaccination in the 4 weeks following the trial vaccination.
* History of influenza infection (confirmed either clinically, serologically or microbiologically) within the 6 months preceding vaccination.
* Previous vaccination against influenza (in the 6 months preceding the trial vaccination).
* Planned receipt of any other 2007-2008 influenza vaccine.
* Thrombocytopenia or bleeding disorder 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.
* History of Guillain-Barré syndrome
* Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
* Any other condition which in the opinion of the investigator would pose a health risk to the participant or interfere with the evaluation of the vaccine.
18 Years
49 Years
ALL
Yes
Sponsors
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Sanofi
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
Mobile, Alabama, United States
Tucson, Arizona, United States
Milford, Connecticut, United States
Pinellas Park, Florida, United States
Chicago, Illinois, United States
Wichita, Kansas, United States
Kansas City, Missouri, United States
Springfield, 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
Countries
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Related Links
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Related Info
Other Identifiers
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GCE03
Identifier Type: -
Identifier Source: org_study_id