116602 - Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix in the United Kingdom

Study identification

• EU PAS number:
  EUPAS5975
• Study ID:
  31677
• Official title and acronym:
  116602 - Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix in the United Kingdom
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Solid organ transplant recipients are a recommended priority group for influenza vaccination due to the increased risk of complications associated with influenza infection. Data on the safety of pandemic H1N1 vaccination in transplanted patients is limited, to date, although some studies showed transient increases in alloreactivity, there is no evidence that H1N1 pandemic influenza vaccines caused clinical rejection. In addition, influenza infection is a known independent risk factor for SOT rejection.Considering that transplant recipients are a target risk group for immunisation with future pandemic vaccines, it is important to investigate the risk of rejection following vaccination in this patient population.The study aimed at investigating the risk of rejection (liver, kidney, lung, heart, pancreas) following vaccination with Pandemrix in the UK Clinical Practice Research Datalink GP Online Database (CPRD GOLD) and the linked Hospital Episodes Statistics (HES) database. Analyses were conducted using the self-controlled case series (SCCS) method for perturbed post-event exposure. The potential confounding effect of time since transplantation, seasonal influenza vaccination and other covariates including previous rejections, infections, and malignancies were also to be explored provided information was available. The risk periods were 30 and 60 days after any vaccine dose. The endpoints for the primary and secondary objectives related to the occurrence of SOT rejection after Pandemrix vaccination within the period from 01 October 2009 to 31 October 2010 are presented below and are detailed in the study report.The study also explored the risk of SOT rejection within one and two months after seasonal influenza vaccination, during influenza seasons 2006/2007, 2007/2008 and 2008/2009, results for this tertiary objective will be reported in an annex report.
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Actual: 07/09/2012

Study start date

Actual: 23/10/2012

Data analysis start date

Actual: 07/08/2013

Date of final study report

Actual: 12/12/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline Biologicals

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)