Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects

Completed · Phase 2

Conditions studied: Influenza, Orthomyxoviruses, Myxovirus Infection

In brief

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: To describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

Key facts

Study ID

NCT00845429

Run by

Sanofi

People needed

729

Starts

2007-10-01

Expected to finish

2008-11-01

Last updated by the study team

2012-12-19

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Hoover, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Milford, Connecticut, United States
• Study site — Pinellas Park, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Wichita, Kansas, United States
• Study site — Kansas City, Missouri, United States
• Study site — Springfield, Missouri, United States
• Study site — Cary, North Carolina, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Bensalem, Pennsylvania, United States
• Study site — Warwick, Rhode Island, United States
• Study site — Mt. Pleasant, South Carolina, United States

Full record on ClinicalTrials.gov

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