NCT00606359

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza
• Orthomyxoviridae Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-02-01
• Completion: 2008-06-01
• First posted: 2008-02-01
• Last updated: 2014-01-14

Locations

1 site across 1 country: France