Influenza Clinical Trial
Official title:
Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in the United Kingdom
This study aims to assess the risk of solid organ transplant (SOT) rejection following vaccination with Pandemrix™ and/ or seasonal influenza vaccination.
Data on the safety of pandemic H1N1 vaccination in transplanted patients is relatively
limited; to date, although some studies showed transient increases in alloreactivity, there
is no evidence that H1N1 vaccines caused clinical rejection or organ dysfunction. In
addition, studies have shown that influenza infection is a known independent risk factors
for rejection. Considering that transplant recipients are a target population for
immunisation with future pandemic vaccines, it is important to investigate the risk of
rejection following vaccination in this patient population.
Using the self-controlled case series design that allows to control implicitly for potential
confounding factors, this study aims at investigating the risk of solid organ transplant
rejection (liver, kidney, lung, heart, pancreas) following vaccination with Pandemrix™ in
the United Kingdom Clinical Practice Research Datalink GP Online Database (CPRD GOLD). Data
from the Hospital Episodes Statistics database will also be used. The effect of seasonal
influenza vaccination and of various infections including influenza H1N1 will also be
explored.
;
Time Perspective: Retrospective
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