Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in European Children

Sanofi Pasteur SA0 sitesStarted: January 12, 2009Last updated: March 19, 2012

Overview

No summary available.

•All Subjects:
•1\) Subject and parent(s)/legal representative able to attend all scheduled visits and to comply with all trial procedures
•2\) Completion of vaccination according to the national immunization schedule
•Subjects Aged \=2 Years to \<18 Years:
•3\) Aged \=2 years to \<18 years on the day of inclusion.
•4\) Provision of Informed Consent Form signed by the subject's the parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 8 to 11 years, and of Informed Consent Form signed by subjects \=12 years.
•5\) For a female of child\-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination.
•Subjects Aged \=6 Months to \<2 Years:
•6\) Aged \=6 months to \<2 years on the day of inclusion.
•7\) Born at full term of pregnancy (\=37 weeks) with a birth weight \=2\.5 kg.

•All subjects:
•1\) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding trial vaccination
•2\) Planned participation in another clinical trial during the present trial period
•3\) 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
•4\) Known systemic hypersensitivity to any of the vaccine components or history of a life\-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
•5\) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
•6\) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
•7\) Receipt of Blood or blood\-derived products in the past 3 months, that might interfere with the assessment of immune response
•8\) Receipt of any vaccine in the 4 weeks preceding trial vaccination
•9\) Planned receipt of any vaccine in the 4 weeks following any trial vaccination

Sponsor

Sanofi Pasteur SA