Assess the Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in UK

Completed

• Conditions: Influenza
• Interventions: Other: Data collection

• Registration Number: NCT01715792
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study aims to assess the risk of solid organ transplant (SOT) rejection following vaccination with Pandemrix™ and/ or seasonal influenza vaccination.

Detailed Description

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-29
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-06
• Last Update Posted: 2014-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 587

Inclusion Criteria

• Subject defined as acceptable in the CPRD GOLD.
• Subject with at least one solid organ transplant rejection reported in the CPRD GOLD and/or HES during the overall study periods (01 September 2006 to 31 October 2010).

Exclusion Criteria

• Subject from HES matched to more than one subject in the CPRD GOLD.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Data collection	Subject defined as acceptable in the CPRD GOLD with at least one solid organ transplant rejection reported during the overall study period (01 September to 31 October 2010).

Primary Outcome Measures

Name	Time	Method
Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).	Within one month after vaccination with Pandemrix™ (from 01 October 2009 to 31 October 2010).	Assessed by case data collection from CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.

Secondary Outcome Measures

Name	Time	Method
Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).	Within two months after vaccination with Pandemrix™ ( from 01 October 2009 to 31 October 2010).	Assessed by case data collection from CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom