A Postmarketing Observational Evaluation of the Safety of FLUENZ in Children and Adolescents With High-risk Conditions

Study identification

• EU PAS number:
  EUPAS18527
• Study ID:
  18619
• Official title and acronym:
  A Postmarketing Observational Evaluation of the Safety of FLUENZ in Children and Adolescents With High-risk Conditions
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This was a post-marketing, observational, prospective cohort study. LAIV recipients were identified from records made available by the Clinical Practice Research Datalink (CPRD), which maintains a large database of anonymised longitudinal medical records from primary care in the UK. These records were then linked to the Hospital Episode Statistics (HES) database.Incidence rates of all-cause hospitalisations were monitored through 42 days and 6 months following LAIV administration and compared with rates observed among inactivated influenza vaccine (IIV) recipients and unvaccinated controls, matched by high-risk condition, age, healthcare utilisation and region. Incidence rates of hospitalisation for lower respiratory events (LRE) were also analysed.
• Study status:
  Finalised

Research institutions and networks

Institutions

MedImmune

Study timelines

Date when funding contract was signed

Actual: 07/05/2012

Study start date

Actual: 17/09/2013

Data analysis start date

Actual: 01/01/2015

Date of final study report

Actual: 16/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

MedImmune

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)

Other study registration identification numbers and links

D2660C00001