Clinical trial NCT00606359: Immunogenicity of the Inactivated Split-Virion Influenza Vaccine in Renal Transplant Subjects
Official title: Immunogenicity of the Inactivated Split-Virion Influenza Vaccine Administered by the Intradermal Route in Renal Transplant Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Orthomyxoviridae Infections
Keywords: Influenza
Orthomyxoviridae Infections
Renal Transplant
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-02-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anti-HA individual titers
timeFrame: 21 Days Post-vaccination 2
measure: Individual titers ratio
timeFrame: 21 Days Post-vaccination 2
measure: Seroconversion or significant increase
timeFrame: 21 Days Post-vaccination 2
Secondary outcomes:
measure: 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.
timeFrame: 21 days following each vaccination
Other outcomes:
Locations:
city: Lyon, Cedex
country: France
city: Lyon
country: France
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: