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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715792
• Other study ID #: 116602
• Status: Completed
• Phase: N/A
• First received: October 25, 2012
• Last updated: February 6, 2014
• Start date: October 2012
• Est. completion date: August 2013

Study information

• Verified date: February 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 587
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Influenza

Intervention

Other:
• Data collection
Data extraction from the CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).	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.	Within one month after vaccination with Pandemrix™ (from 01 October 2009 to 31 October 2010).	No
Secondary	Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).	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.	Within two months after vaccination with Pandemrix™ ( from 01 October 2009 to 31 October 2010).	No