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

Immunogenicity of the Inactivated Split-Virion Influenza Vaccine Administered by the Intradermal Route in Renal Transplant Subjects

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

Study Overview

• Status: Completed
• Conditions: Influenza; Orthomyxoviridae Infections
• Intervention / Treatment: Biological: Inactivated, split-virion influenza virus; Biological: Inactivated, split-virion influenza virus

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Lyon, France
  • Lyon, Cedex, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group 1	Biological: Inactivated, split-virion influenza virus; 0.1 mL, Intradermal. 2 vaccinations 12 months apart; Biological: Inactivated, split-virion influenza virus; 0.5 mL, Intramuscular. 2 vaccinations, 12 months apart; Other Names: Vaxigrip®
Active Comparator: Study Group 2	Biological: Inactivated, split-virion influenza virus; 0.1 mL, Intradermal. 2 vaccinations 12 months apart; Biological: Inactivated, split-virion influenza virus; 0.5 mL, Intramuscular. 2 vaccinations, 12 months apart; Other Names: Vaxigrip®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: January 21, 2008
• First Submitted That Met QC Criteria: January 31, 2008
• First Posted (Estimate): February 1, 2008

Study Record Updates

• Last Update Posted (Estimate): January 14, 2014
• Last Update Submitted That Met QC Criteria: January 10, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Influenza; Orthomyxoviridae Infections; Renal Transplant
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Influenza, Human; Orthomyxoviridae Infections
• Other Study ID Numbers: GID26