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

Not Applicable

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

• Registration Number: ISRCTN95881792
• Lead Sponsor: niversity of Dundee

Brief Summary

2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35649591/ Adverse events and overall health and well-being after COVID-19 vaccination results (added 08/06/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-21
• Last Update Posted: 27 March 2023
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 21104

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
<br> 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:<br> 1. Adverse events prior to and after vaccination for the whole vaccinated and unvaccinated population and in predefined subgroups<br> 2. All-cause mortality rate for the whole study population and predefined subgroups<br> 3. Rates and severity of participant-reported symptomatic COVID-19 infection in vaccinated and unvaccinated cohorts<br> 4. Reported reasons for non-vaccination<br>