Status:
TERMINATED
Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated With AZD1222
Lead Sponsor:
AstraZeneca
Conditions:
Coronavirus Disease 2019 (COVID-19)
Eligibility:
All Genders
18-130 years
Brief Summary
This is a Phase IV real-world, observational, non-interventional, prospective cohort study of adults vaccinated with AZD1222. The purpose of this study is to assess the safety and tolerability of AZD1...
Detailed Description
The study will use an innovative digital platform (study app and web portal) as well as a traditional call centre to collect participant responses to a series of health and well-being questionnaires o...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Aged 18 or older at the time of vaccination.
- Received AZD1222 as the first dose of COVID-19 vaccination in the prior 28 days.
- The participant has provided sufficient details to validate the vaccination (vaccination card, batch/lot number, and/or regional vaccination register details).
- Provided informed consent to participate in the study, either personally or through a legal representative.
- Able and willing to provide responses to study notifications using the mobile device app, web portal, or call centre or have a proxy (a caregiver, family member, or other trusted individual) who can do so on their behalf.
- Able and willing to grant, personally or through a legal representative, permission to contact the participant's healthcare providers and to access the participant's medical records at the time of vaccination and during the post-vaccination follow-up period.
Exclusion
Key Trial Info
Start Date :
May 31 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 24 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04877743
Start Date
May 31 2021
End Date
November 24 2021
Last Update
June 30 2022
Active Locations (1)
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1
Research Site
Essen, Germany, 45355