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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606359
• Other study ID #: GID26
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2008
• Last updated: January 10, 2014
• Start date: November 2007
• Est. completion date: June 2008

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Orthomyxoviridae Infections

Intervention

Biological:
• Inactivated, split-virion influenza virus
0.1 mL, Intradermal. 2 vaccinations 12 months apart
• Inactivated, split-virion influenza virus
0.5 mL, Intramuscular. 2 vaccinations, 12 months apart

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HA individual titers		21 Days Post-vaccination 2	No
Primary	Individual titers ratio		21 Days Post-vaccination 2	No
Primary	Seroconversion or significant increase		21 Days Post-vaccination 2	No
Secondary	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	Yes

External Links

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