Immunogenicity of the Inactivated Split-Virion Influenza Vaccine in Renal Transplant Subjects
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00606359
First received: January 21, 2008
Last updated: February 9, 2010
Last verified: February 2010
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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 More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Monitor, Sanofi Pasteur, Inc |
| ClinicalTrials.gov Identifier: | NCT00606359 History of Changes |
| Other Study ID Numbers: | GID26 |
| Study First Received: | January 21, 2008 |
| Last Updated: | February 9, 2010 |
| 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 May 16, 2013