Cohort Event Monitoring of safety of COVID-19 vaccines (Early-) Covid-Vaccine-Monitor (Covid-Vaccine-Monitor ECVM CVM)

Study type

• Study topic:
  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective cohort study, Prescription event monitoring

Population studied

• Short description of the study population:
  The study population included recipients of covid-19 vaccines identified through six European countries: The Netherlands, Italy, France, United Kingdom, Germany, and Croatia.; Inclusion criteria: ; Participants to be included should be vaccinated in one of the participating countries in the period February onwards until the minimal amount of inclusions has been reached. The vaccine recipient or their proxy should:; • register for the study prior to (the first) vaccination or no longer than 2 days after COVID-19 vaccination;; • be able to understand the language of the survey (which should at least be translated into the local official languages);; • be able to register and participate by e-mail;; • provide informed consent (which should at least be translated into the local official languages)
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  57000

Study design details

• Main study objective:
  to generate incidence rates of patient-reported ADRs of COVID-19 vaccine brand in near real time.
• Outcomes:
  Participants will be asked to report adverse reactions after vaccination at multiple follow-up time points. These adverse reactions are known to frequently occur. In addition, it will be asked whether any other adverse reactions occurred (open question/unsolicited).
• Data analysis plan:
  A description of the population at inclusion will be made by participating parties, comprising of the number of patients included in the cohort, distribution of gender, age categories (to be defined), country and additional core data. A dedicated cumulative structured overview of numbers and incidence rate of all adverse reactions per vaccine will be provided every month, overall, and also stratified by vaccine brand, country, gender and age group. For each ADR, incidence rate with its 95% confidence interval (CI) will be reported by COVID-19 vaccine brand and dose. Monthly overviews will be made available on a national level for national competent authorities but also made available to the partners.

Documents

Study results

EUPAS39798-105810

EUPAS39798-106508

Study publications

Raethke M, van Hunsel F, Thurin NH, Dureau-Pournin C, Mentzer D, Kovačić B, Mir…

Luxi, N, Raethke, M, Ruijs, L, Schmikli, S, Riefolo, F, Trifiro, G, & Sturkenbo…

Raethke, Monika, Ruijs, Loes, Schmitz, Jasper, Perez-Gutthan, Susana, Droz, Céc…

Luxi Nicoletta, Riefolo Fabio, Raethke Monika, van Hunsel Florence, Sturkenboom…