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

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Sanofi

Status and phase

Completed
Phase 2

Conditions

Influenza
Orthomyxoviridae Infections

Treatments

Biological: Inactivated, split-virion influenza virus

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

62 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

62 participants in 2 patient groups

Study Group 1
Experimental group
Treatment:
Biological: Inactivated, split-virion influenza virus
Biological: Inactivated, split-virion influenza virus
Study Group 2
Active Comparator group
Treatment:
Biological: Inactivated, split-virion influenza virus
Biological: Inactivated, split-virion influenza virus

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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