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

NCT ID: NCT00606359

Last Updated: 2014-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-06-30

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.

Conditions

Influenza; Orthomyxoviridae Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Study Group 1

Group Type: EXPERIMENTAL

Inactivated, split-virion influenza virus

Intervention Type: BIOLOGICAL

0.1 mL, Intradermal. 2 vaccinations 12 months apart

Study Group 2

Group Type: ACTIVE_COMPARATOR

Inactivated, split-virion influenza virus

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular. 2 vaccinations, 12 months apart

Interventions

Inactivated, split-virion influenza virus

0.1 mL, Intradermal. 2 vaccinations 12 months apart

Intervention Type: BIOLOGICAL

Inactivated, split-virion influenza virus

0.5 mL, Intramuscular. 2 vaccinations, 12 months apart

Intervention Type: BIOLOGICAL

Other Intervention Names

Vaxigrip®

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Lyon, , France

Countries

France

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

GID26

Identifier Type: -

Identifier Source: org_study_id