Immunogenicity of the Inactivated Split-Virion Influenza Vaccine in Renal Transplant Subjects
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Study Group 1
|
Biological: Inactivated, split-virion influenza virus
0.1 mL, Intradermal. 2 vaccinations 12 months apart
|
| Active Comparator: Study Group 2
|
Biological: Inactivated, split-virion influenza virus
0.5 mL, Intramuscular. 2 vaccinations, 12 months apart
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Able to attend all scheduled visits and to comply with all trial procedures.
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Subject with renal transplant for at least 6 months.
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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.
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Aged 18 to 59 years on the day of the screening visit.
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Informed Consent Form signed.
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Subject entitled to national social security.
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Subject under immunosuppressive therapy.
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For a woman, inability to bear a child or negative urine pregnancy test.
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Subject non-responder to previous IM vaccination with the 2006-2007 Northern Hemisphere Vaxigrip® formulation.
Exclusion Criteria:
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Subject with sign of transplanted kidney reject within 3 months preceding vaccination according to medical practice.
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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.
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Febrile illness (oral temperature ≥ 37.5°C, or rectal equivalent temperature ≥ 38.0°C) on the day of inclusion.
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Breast-feeding.
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Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
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Planned participation in another clinical trial during the present trial period.
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Congenital immunodeficiency, anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
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Chronic illness, except renal failure or renal disorders, at a stage that could interfere with trial conduct or completion.
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Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
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Blood or blood-derived products received in the past 3 months .
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Any vaccination in the 4 weeks preceding the trial vaccination.
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Vaccination planned in the 4 weeks following the trial vaccination.
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Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
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Previous vaccination against influenza in the preceding 6 months.
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Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lyon, Cedex | France | |||
| 2 | Lyon | France |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Director, Sanofi Pasteur Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- GID26