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

Phase 2

Completed

• Conditions: Influenza; Orthomyxoviridae Infections
• Interventions: Biological: Inactivated, split-virion influenza virus

• Registration Number: NCT00606359
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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 Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-01-21
• Study First Submitted QC: 2008-01-31
• Primary Completion: 2008-02
• Study First Posted: 2008-02-01
• Study Completion: 2008-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group 1	Inactivated, split-virion influenza virus	-
Study Group 2	Inactivated, split-virion influenza virus	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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