NCT00606359CompletedPhase 2
Immunogenicity of the Inactivated Split-Virion Influenza Vaccine Administered by the Intradermal Route in Renal Transplant Subjects
Sanofi Pasteur, a Sanofi Company2 sites in 1 country62 target enrollmentStarted: November 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Anti-HA individual titers
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Study Group 1
Experimental
Intervention: Inactivated, split-virion influenza virus (Biological)
Study Group 2
Active Comparator
Intervention: Inactivated, split-virion influenza virus (Biological)
Outcomes
Primary Outcomes
Anti-HA individual titers
Time Frame: 21 Days Post-vaccination 2
Individual titers ratio
Time Frame: 21 Days Post-vaccination 2
Seroconversion or significant increase
Time Frame: 21 Days Post-vaccination 2
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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