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

Primary Purpose

Influenza, Orthomyxoviridae Infections

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Inactivated, split-virion influenza virus

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Orthomyxoviridae Infections, Renal Transplant

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Group 1

Study Group 2

Arm Description

Outcomes

Primary Outcome Measures

Anti-HA individual titers

Individual titers ratio

Seroconversion or significant increase

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.

Full Information

NCT ID

NCT00606359

First Posted

January 21, 2008

Last Updated

January 10, 2014

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00606359

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Orthomyxoviridae Infections

Keywords

Influenza, Orthomyxoviridae Infections, Renal Transplant

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Group 1

Arm Type

Experimental

Arm Title

Study Group 2

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

Inactivated, split-virion influenza virus

Intervention Description

0.1 mL, Intradermal. 2 vaccinations 12 months apart

Intervention Type

Biological

Intervention Name(s)

Inactivated, split-virion influenza virus

Other Intervention Name(s)

Vaxigrip®

Intervention Description

0.5 mL, Intramuscular. 2 vaccinations, 12 months apart

Primary Outcome Measure Information:

Title

Anti-HA individual titers

Time Frame

21 Days Post-vaccination 2

Title

Individual titers ratio

Time Frame

21 Days Post-vaccination 2

Title

Seroconversion or significant increase

Time Frame

21 Days Post-vaccination 2

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Sanofi Pasteur Inc.

Official's Role

Study Director

Facility Information:

City

Lyon, Cedex

Country

France

City

Lyon

Country

France

12. IPD Sharing Statement

Links:

URL

http://www.sanofipasteur.com

Description

Related Info

Learn more about this trial

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

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