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

NCT00606359 | Completed Phase 2 DMC

• 1 other identifier: GID26
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Conditions

Influenza; Orthomyxoviridae Infections

Keywords

Influenza; Orthomyxoviridae Infections; Renal Transplant

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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

Study Arms (2)

Study Group 1

EXPERIMENTAL

Biological: Inactivated, split-virion influenza virus

Study Group 2

ACTIVE COMPARATOR

Biological: Inactivated, split-virion influenza virus

Interventions

Inactivated, split-virion influenza virus BIOLOGICAL

0.1 mL, Intradermal. 2 vaccinations 12 months apart

Study Group 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to attend all scheduled visits and to comply with all trial procedures.
• Subject with renal transplant for at least 6 months.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Lyon, France

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human; Orthomyxoviridae Infections

Interventions

vaxigrip

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2008
• First Posted: February 1, 2008
• Study Start: November 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: June 1, 2008
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

FR (1)