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

  • Paediatric Population (< 18 years)
    • Neonate
      • 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)
  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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.