drugset / Trial / NCT00606359

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

NCT00606359

Phase 2 Completed 62 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupOpen-labelPrevention

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

Timeline

Start
2007-11
Primary completion
2008-02
Completion
2008-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Inactivated, Split-Virion Influenza Virus Vaccine 0.1 ml Intramuscular
Comparator Inactivated, Split-Virion Influenza Virus Vaccine 0.5 ml Intramuscular

Indications