Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2006-2007 Formulation (Intramuscular Route) - N/A

Sanofi Pasteur SA0 sites120 target enrollmentApril 10, 2006

Overview

No summary available.

Registry

who.int

Start Date

April 10, 2006

End Date

August 9, 2006

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Sanofi Pasteur SA

•1\) Aged at least 18 years on the day of inclusion
•2\) Informed consent form signed
•3\) Able to attend all scheduled visits and to comply with all trial procedures
•4\) For a woman, inability to bear a child or negative urine pregnancy test at V01
•5\) For a woman of child\-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least three weeks after vaccination.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes

•1\) Febrile illness (oral temperature \=37\.5°C) on the day of vaccination
•2\) Breast\-feeding
•3\) Participation in another clinical trial in the four weeks preceding the trial vaccination
•4\) Planned participation in another clinical trial during the present trial period
•5\) 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
•6\) Systemic hypersensitivity to egg proteins, chick 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
•7\) Chronic illness at a stage that could interfere with trial conduct or completion
•8\) Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures
•9\) Blood or blood\-derived products received in the past three months
•10\) Any vaccination in the four weeks preceding the trial vaccination