A non-interventional study of LAIV utilization to identify and characterize medication errors due to expired vaccine use in individuals 2-17 years of age in the CPRD

Study identification

• EU PAS number:
  EUPAS11799
• Study ID:
  28019
• Official title and acronym:
  A non-interventional study of LAIV utilization to identify and characterize medication errors due to expired vaccine use in individuals 2-17 years of age in the CPRD
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study is intended to provide data to identify and characterize the proportion of expired LAIV administrations during the past two influenza seasons (2013-2014, 2014-15) and to identify risk factors for this medication error. In addition, there is interest in quantifying the frequency distribution of days between expiration and vaccination date.
• Study status:
  Finalised

Research institutions and networks

Institutions

Clinical Practice Research Datalink (CPRD)

United Kingdom

Study timelines

Date when funding contract was signed

Planned:05/11/2015

Actual:06/11/2015

Study start date

Planned:01/12/2015

Actual:30/11/2015

Data analysis start date

Planned:01/12/2015

Actual:30/11/2015

Date of interim report, if expected

Actual:30/12/2015

Date of final study report

Planned:29/04/2016

Actual:30/05/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable