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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
62
0.1 mL, Intradermal. 2 vaccinations 12 months apart
0.5 mL, Intramuscular. 2 vaccinations, 12 months apart
Unnamed facility
Lyon, France
Anti-HA individual titers
Time frame: 21 Days Post-vaccination 2
Individual titers ratio
Time frame: 21 Days Post-vaccination 2
Seroconversion or significant increase
Time frame: 21 Days Post-vaccination 2
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
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