Status:
COMPLETED
Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
Lead Sponsor:
Sanofi
Conditions:
Influenza
Orthomyxoviruses
Eligibility:
All Genders
18-49 years
Phase:
PHASE2
Brief Summary
Primary Objective: 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: ...
Detailed Description
This is a multi-center study in healthy adult subjects. All subjects will receive a single dose of one of the influenza vaccine formulations and will provide blood samples for immunogenicity assessmen...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Healthy male or female subject, aged ≥ 18 to \< 50 years on the day of inclusion
- 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 :
- Subject currently breast-feeding.
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
729 Patients enrolled
Trial Details
Trial ID
NCT00845429
Start Date
October 1 2007
End Date
November 1 2008
Last Update
December 19 2012
Active Locations (15)
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1
Hoover, Alabama, United States, 35216
2
Mobile, Alabama, United States, 36608
3
Tucson, Arizona, United States, 85710
4
Milford, Connecticut, United States, 06460