SARS-CoV-2 vaccination for COVID-19 disease safety study

SARS-CoV-2 Vaccination for COVID-19 Disease Safety Study (VAC4COVID Study): a prospective, active observational, post-authorisation surveillance safety study (PASS) of vaccines for COVID-19 disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN95881792

Enrollment

20000

Registered

2020-12-21

Start date

2021-02-03

Completion date

Unknown

Last updated

2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety monitoring for all COVID-19 (SARS-CoV-2 infection) vaccinations Not Applicable

Interventions

Participants will be recruited pre and post COVID-19 vaccination and will include people who decide not to be vaccinated. It is an online, observational study where patients fill in initial health and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years and over (participants with primary caring responsibilities for children under the age of 18 may submit information on the child’s behalf with age-appropriate agreement) 2. Valid email address (per adult participant) and able to access and use the internet 3. Subjects willing to nominate at least one, preferably two, emergency contact(s)

Exclusion criteria

Exclusion criteria: 1. No access to internet enabled devices to enable participation 2. Unable to consent due to incapacity 3. Unwilling or unable to nominate at least one emergency contact

Design outcomes

Primary

Measure	Time frame
SAEs reported by participants, emergency contacts and healthcare professionals both prior to and after vaccination for the whole vaccinated and unvaccinated population, as well as for predefined subgroups, during the study observation period. Special attention will be given to AESI, updated lists of which may be produced by regulators/health authorities during the study based on the most recent updates regarding vaccine development and safety.	—

Measure

Time frame

SAEs reported by participants, emergency contacts and healthcare professionals both prior to and after vaccination for the whole vaccinated and unvaccinated population, as well as for predefined subgroups, during the study observation period. Special attention will be given to AESI, updated lists of which may be produced by regulators/health authorities during the study based on the most recent updates regarding vaccine development and safety.

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Secondary

Measure	Time frame
Reported by participants, healthcare professionals, medical records (including written and electronic records, and national databases, where possible), and emergency contacts during the study observation period: 1. Adverse events prior to and after vaccination for the whole vaccinated and unvaccinated population and in predefined subgroups 2. All-cause mortality rate for the whole study population and predefined subgroups 3. Rates and severity of participant-reported symptomatic COVID-19 infection in vaccinated and unvaccinated cohorts 4. Reported reasons for non-vaccination	—

Measure

Time frame

Reported by participants, healthcare professionals, medical records (including written and electronic records, and national databases, where possible), and emergency contacts during the study observation period: 1. Adverse events prior to and after vaccination for the whole vaccinated and unvaccinated population and in predefined subgroups 2. All-cause mortality rate for the whole study population and predefined subgroups 3. Rates and severity of participant-reported symptomatic COVID-19 infection in vaccinated and unvaccinated cohorts 4. Reported reasons for non-vaccination

—

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026