Status: Planned
First registered on:
23/03/2021
Last updated on:
18/10/2021
1. Study identification
EU PAS Register NumberEUPAS40259
Official titleEUMAEUS: Evaluating Use of Methods for Adverse Event Under Surveillance (for vaccines)
Study title acronymEUMAEUS
Study typeObservational study
Brief description of the study
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameNA
Centre locationNA
Details of (Primary) lead investigator
Title Dr
Last name Schuemie
First name Martijn J
Is this study being carried out with the collaboration of a research network?
Yes
OHDSI
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
International study
Netherlands
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/02/2021
Start date of data collection01/03/2021
Start date of data analysis
Date of interim report, if expected
Date of final study report01/09/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherThis is an open science study with collaborators from multiple institutions across academia, regulators, and industry100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Schuemie
First name Martijn J
Address line 1Observational Data Health Analytics
Address line 2Janssen Research and Development
Address line 3NJ
CityTitusville
Postcode
CountryUnited States
Phone number (incl. country code)310631793897
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Schuemie
First name Martijn J
Address line 1Observational Data Health Analytics
Address line 2Janssen Research and Development
Address line 3NJ
CityTitusville
Postcode
CountryUnited States
Phone number (incl. country code)310631793897
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)J07B
7. Medical conditions to be studied
Medical condition(s)No
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects2000000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Administrative database, e.g. claims database
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Methods research
Primary scope : Methods research
12. Main objective(s)
What is the main objective of the study?
The overarching aim is to identify the best methods for the generation of evidence of
vaccine safety in observational, real-world data
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
Case-control study
Self controlled case-series
Historical rate comparison
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
• 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
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
Vaccine safety surveillance using routinely collected healthcare data – An empirical evaluation of epidemiological designs
Martijn J. Schuemie, Faaizah Arshad, Nicole Pratt, Fredrik Nyberg, Thamir M Alshammari, George Hripcsak, Patrick Ryan, Daniel Prieto-Alhambra, Lana YH Lai, Xintong Li, Fortin Stephen, Evan Minty, Marc A. Suchard
medRxiv 2021.08.09.21261780; doi: https://doi.org/10.1101/2021.08.09.21261780https://www.medrxiv.org/content/10.1101/2021.08.09.21261780v1
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
