Status: Finalised
First registered on:
22/09/2020
Last updated on:
09/01/2023
1. Study identification
EU PAS Register NumberEUPAS37273
Official titleBackground rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines
Study title acronymACCESS-BGR
Study typeObservational study
Brief description of the studyThis study aims to generate background rates of adverse events of special interest for monitoring of COVID-19 vaccines, in 10 healthcare databases in 7 European countries
Was this study requested by a regulator?Yes: EMA
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 to which the investigator belongsUMCU
Department/Research groupJulius Global Health
Organisation/affiliationUniversity Medical Center Utrecht
Details of (Primary) lead investigator
Title Professor
Last name Sturkenboom
First name Miriam
Is this study being carried out with the collaboration of a research network?
Yes
European PE & PV network
Other centres where this study is being conducted
Multiple centres
In total how many centres are involved in this Study?12
SoSeTe, Italy
Countries in which this study is being conducted
International study
Denmark
France
Germany
Italy
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed19/05/202019/05/2020
Start date of data collection01/10/202001/10/2020
Start date of data analysis16/11/2020
Date of interim report, if expected15/12/2020
Date of final study report29/01/202130/06/2021
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
OtherEuropean medicines Agency100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Sturkenboom
First name Miriam
Address line 1Heidelberglaan 100
Address line 2
Address line 3
CityUtrecht
Postcode
CountryNetherlands
Phone number (incl. country code)31887555555
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Sturkenboom
First name Miriam
Address line 1Heidelberglaan 100
Address line 2
Address line 3
CityUtrecht
Postcode
CountryNetherlands
Phone number (incl. country code)31887555555
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Guillain-Barre syndrome
Acute disseminated encephalomyelitis
Cutaneous vasculitis
Acute respiratory distress syndrome
Fetal growth restriction
Type 1 diabetes mellitus
Coronary artery disease
Termination of pregnancy - medical
Gestational diabetes
Acute kidney injury
Additional Medical Condition(s)
Narcolepsy, Acute aseptic arthritis, Thrombocytopenia, Microangiopathy, Hearth failur, Stress cardiomyopatly, Arrhythmia, Myocarditis, Thromboembolism, Haemorrhage, Acute liver injury, Generalized convulsion, Meningoencephalitis, Erythema multiforme, Chilblain-like lesion, Anosmia, Anaphylaxis, Multisystem Inflammatory disease, COVID-19, Preeclampsia, Stillbirth, Major congenital anomaly, Death
8. Population under study
Age
Preterm newborns
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
Other population
Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women
9. Number of subjects
Estimated total number of subjects130
Additional information
Number of subjects expressed in millions
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Data sources not registered with ENCePP
SNDS, France
Sources of data
Administrative database, e.g. claims database
Routine primary care electronic patient registry
Pharmacy dispensing records
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
To generate background incidence rates of adverse events of special interest (AESI) that may be used to monitor benefit-risk profile of upcoming COVID-19 vaccines.
Are there primary outcomes?Yes
Incidence rates of adverse events of special interest (AESI) and pregnancy outcomes in the general population by calendar year and data source over the period 2017 to 2020; Weekly and monthly incidence rates of COVID-19 (overall and by severity level) in 2020 by data source; Monthly incidence rates of multisystem inflammatory syndrome in children (MIS-C) in 2020 by data source.
Are there secondary outcomes?Yes
Incidence rates of AESI by calendar month, year, sex, age group, and data source over the period 2017 to 2020; Incidence rates of multisystem MIS-C in 2020 by month, sex, age group, and data source; Prevalence of high-risk medical conditions for developing severe COVID-19 by year and data source; incidence rates of AESI in the at-risk population by year, sex, age group, and data source
13. Study design
What is the design of the study?
Cohort study
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
Incidence rates (and 95%CI) of AESI and pregnancy outcomes by calendar year will be calculated by dividing the number of incident (new) cases by the total person-time at risk.
Prevalence rates (and 95%CI) of at-risk medical conditions for developing severe COVID-19 by calendar year will be calculated by dividing the number of existing cases in a year by the average of the total number of persons recorded monthly. Incidence rates (and 95%CI) of AESI among at-risk populations will also be computed.
Sensitivity analyses will be conducted according to the time prior to SARS-CoV2 circulation and during SARS-CoV2 circulation period to investigate the impact of circulating virus on incidence rates.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
Willame, C; Dodd, C; Gini, R; Durán, CE; Thomsen, RM; Wang, L; Gedebjerg, A; Kahlert, J; Ehrenstein, V; Bartolini, C; Droz, C; Moore, N; Haug, U; Schink, T; Diez-Domingo, J; Mira-Iglesias, A; Vergara-Hernández, C; Carreras, JJ; Villalobos, F; Pallejà, M; Aragón, M; Perez-Gutthann ,S; Arana, A; Giaquinto, C; Barbieri, E; Stona, L; Huerta, C; Pallejà, M; Aragón, M; García Poza, P; de Burgos, A; Martínez-González, M; Souverein, P; Gardarsdottir, H; Siiskonen, SJ; Weibel, D; Mahy, P; Klungel, O; Sturkenboom, MCJM
(2021). Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines (2.0). Zenodo.https://doi.org/10.5281/zenodo.5255870
Willame C, Dodd C, Durán CE, Elbers R, Gini R, Bartolini C, Paoletti O, Wang L, Ehrenstein V, Kahlert J, Haug U, Schink T, Diez-Domingo J, Mira-Iglesias A, Carreras JJ, Vergara-Hernández C, Giaquinto C, Barbieri E, Stona L, Huerta C, Martín-Pérez M, García-Poza P, de Burgos A, Martínez-González M, Bryant V, Villalobos F, Pallejà-Millán M, Aragón M, Carreras JJ, Souverein P, Thurin NH, Weibel D, Klungel OH, Sturkenboom M. Background rates of 41 adverse events of special interest for COVID-19 vaccines in 10 European healthcare databases - an ACCESS cohort study. Vaccine. 2023 Jan 4;41(1):251-262. doi: 10.1016/j.vaccine.2022.11.031. Epub 2022 Nov 22. PMID: 36446653; PMCID: PMC9678835.https://pubmed.ncbi.nlm.nih.gov/36446653/
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
