Influenza, Orthomyxoviridae Infections
Conditions
Keywords
Influenza, Orthomyxoviridae Infections, Renal Transplant
Brief summary
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
Detailed description
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.
Interventions
0.1 mL, Intradermal. 2 vaccinations 12 months apart
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-HA individual titers | 21 Days Post-vaccination 2 |
| Individual titers ratio | 21 Days Post-vaccination 2 |
| Seroconversion or significant increase | 21 Days Post-vaccination 2 |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Adverse events in the first 21 days after each vaccination; Pre-listed reactions in the 7 days following each vaccination; Serious adverse events during the entire trial. | 21 days following each vaccination |
Countries
France
Outcome results
None listed