Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)

Sanofi Pasteur SA0 sitesMarch 28, 2008

Overview

No summary available.

Registry

who.int

Start Date

March 28, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Sanofi Pasteur SA

•1\) Aged 18 to 60 years (i.e. to the day before the 61st birthday) or 61 years or older (from the day of the 61st birthday) on the day of inclusion
•2\) Provision of a signed informed consent
•3\) Able to attend all scheduled visits and comply with all trial procedures
•4\) For a woman of child\-bearing potential: avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 21 days 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
•F.1\.3\.1 Number of subjects for this age range

•1\) For a woman of child\-bearing potential, known pregnancy or positive urine pregnancy test at V01
•2\) Febrile illness (temperature \=37\.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
•3\) Breast\-feeding woman
•4\) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
•5\) Planned participation in another clinical trial during the present trial period
•6\) 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
•7\) Known systemic hypersensitivity to egg proteins, chick proteins, neomycin, formaldehyde and octoxinol 9, or to any of the vaccine components, or history of a life\-threatening reaction to the trial vaccine or a vaccine containing any of the same substances
•8\) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
•9\) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
•10\) Receipt of blood or blood\-derived products in the past 3 months, that might interfere with the assessment of immune response