Immunogenicity of the Inactivated Split-Virion Influenza Vaccine in Renal Transplant Subjects

Immunogenicity of the Inactivated Split-Virion Influenza Vaccine Administered by the Intradermal Route in Renal Transplant Subjects

Primary Objective:

To describe the immunogenicity of an injection of the investigational inactivated, split-virion influenza vaccine 21 days after vaccination in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine (Vaxigrip®).

Secondary Objective:

To describe the safety of an injection of the investigational inactivated, split-virion influenza vaccine in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine

The trial is a multicenter, randomized, controlled trial in renal transplant subjects aged 18 to 60 years who are non-responders to vaccination with the reference vaccine. Subjects will be randomized to receive either the 2007-2008 15 µg investigational vaccine or the 2007-2008 IM reference vaccine.

Inclusion Criteria:

• Able to attend all scheduled visits and to comply with all trial procedures.
• Subject with renal transplant for at least 6 months.
• Subject with stable renal function, i.e. with a variation of creatinin value < 20% and with a creatinin clearance estimated according to Cockroft and Gault calculation > 20 mL/min during the 3 months preceding inclusion.
• Aged 18 to 59 years on the day of the screening visit.
• Informed Consent Form signed.
• Subject entitled to national social security.
• Subject under immunosuppressive therapy.
• For a woman, inability to bear a child or negative urine pregnancy test.
• Subject non-responder to previous IM vaccination with the 2006-2007 Northern Hemisphere Vaxigrip® formulation.

Exclusion Criteria:

• Subject with sign of transplanted kidney reject within 3 months preceding vaccination according to medical practice.
• Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
• Febrile illness (oral temperature ≥ 37.5°C, or rectal equivalent temperature ≥ 38.0°C) on the day of inclusion.
• Breast-feeding.
• Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
• Planned participation in another clinical trial during the present trial period.
• Congenital immunodeficiency, anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
• Chronic illness, except renal failure or renal disorders, at a stage that could interfere with trial conduct or completion.
• Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
• Blood or blood-derived products received in the past 3 months .
• Any vaccination in the 4 weeks preceding the trial vaccination.
• Vaccination planned in the 4 weeks following the trial vaccination.
• Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
• Previous vaccination against influenza in the preceding 6 months.
• Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.