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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Influenza, Orthomyxoviridae Infections

Intervention / Treatment
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* Biological: Inactivated, split-virion influenza virus
* Biological: Inactivated, split-virion influenza virus


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group 1<br> | Biological: Inactivated, split-virion influenza virus<br>* 0.1 mL, Intradermal. 2 vaccinations 12 months apart<br>|
| Active Comparator: Study Group 2<br> | Biological: Inactivated, split-virion influenza virus<br>* 0.5 mL, Intramuscular. 2 vaccinations, 12 months apart<br>* Other names: Vaxigrip®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Orthomyxoviridae Infections, Renal Transplant