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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00606359
First received: January 21, 2008
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Influenza
Orthomyxoviridae Infections
Biological: Inactivated, split-virion influenza virus
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity of the Inactivated Split-Virion Influenza Vaccine Administered by the Intradermal Route in Renal Transplant Subjects

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Anti-HA individual titers [ Time Frame: 21 Days Post-vaccination 2 ] [ Designated as safety issue: No ]
  • Individual titers ratio [ Time Frame: 21 Days Post-vaccination 2 ] [ Designated as safety issue: No ]
  • Seroconversion or significant increase [ Time Frame: 21 Days Post-vaccination 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 21 days following each vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: November 2007
Study Completion Date: June 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group 1 Biological: Inactivated, split-virion influenza virus
0.1 mL, Intradermal. 2 vaccinations 12 months apart
Active Comparator: Study Group 2 Biological: Inactivated, split-virion influenza virus
0.5 mL, Intramuscular. 2 vaccinations, 12 months apart
Other Name: Vaxigrip®

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606359

Locations
France
Lyon, France
Lyon, Cedex, France
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00606359     History of Changes
Other Study ID Numbers: GID26
Study First Received: January 21, 2008
Last Updated: January 10, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
Influenza
Orthomyxoviridae Infections
Renal Transplant

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014