EUMAEUS: Evaluating Use of Methods for Adverse Event Under Surveillance (for vaccines)

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

  Case-control

  Other
• Non-interventional study design, other:
  Self-controlled case series, Historical rate comparison

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07B) VIRAL VACCINES

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  2000000

Study design details

• Main study objective:
  The overarching aim is to identify the best methods for the generation of evidence of vaccine safety in observational, real-world data
• Data analysis plan:
  • Design: Cohort, self-controlled, and case-control studies • Exposures: previous viral vaccines including 2017-2018 flu, H1N1 flu, Human Papillomavirus (HPV), and Varicella-Zoster. • Outcomes: selected adverse events of special interest, negative control outcomes, synthetic positive control outcomes • Analyses: 1. Historical rate comparisons. 2. Cohort analyses using a contemporary non-user comparator, with large-scale propensity score matching 3. Self-controlled case series with variations 4. Case-control analyses

Documents

Study publications

Schuemie MJ, Arshad F, Pratt N, Nyberg F, Alshammari TM, Hripcsak G, Ryan P, Pr…