Human Influenza Clinical Trial
Official title:
Open Label Parallel Randomized Clinical Trial to Evaluate the Immunogenicity of Three Regimens of the Trivalent Influenza Vaccine (Inactivated and Fragmented) in Kidney Transplant Recipients
This will be an open label, parallel, randomized clinical trial that will evaluate the
immunogenicity and safety of the trivalent influenza vaccine (inactivated and fragmented)
produced by Instituto Butantan among adult kidney transplant recipients, when administered
in three vaccination regimens: i) the recommended dose; ii) a single double dose; iii) two
doses administered with a 21 day interval.
The randomization ratio among the three groups of kidney transplant recipients will be 1:1,
and 60 participants will be included in each group. After vaccination all participants will
be followed for 26 weeks.
In addition, 15 healthy adults will be included as a control group, and will receive the
recommended dose.
The study hypothesis is that a different vaccination regimen can improve the immune response
of kidney transplant recipients after vaccination with the trivalent influenza vaccine
(inactivated and fragmented).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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