Study identifier:D8111R00003
ClinicalTrials.gov identifier:NCT04877743
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase IV Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated with AZD1222
Coronavirus disease 2019 (COVID-19)
Phase 4
Yes
-
All
27
Observational
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Jun 2022 by AstraZeneca
AstraZeneca
-
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 AZD1222 in adults vaccinated in real-world settings.
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 over an 18-month period. Research coordinators at vaccination sites will invite vaccinated adults to join the study. Participants can enrol at the vaccination site with assistance from a research coordinator or can take home a study information brochure and enrol within 28 days after the first dose of AZD1222. Research coordinators and the study call centre will be available to assist with enrolment and informed consent, as needed. Electronic consent using the study app will be an option where permitted. Participants using the digital platform will set up a secure account, complete the enrolment questionnaires, and provide details of their vaccination to confirm eligibility. Non-digital participants will complete the enrolment questionnaires and confirm eligibility at a vaccination site or by a telephone call to the call centre. After enrolment, participants will be contacted to complete follow-up questionnaires at timed intervals over an 18-month period after their first AZD1222 dose. Digital participants will receive push notifications or emails and non-digital participants will receive phone calls. Participants can also submit unscheduled adverse event (AE) reports through the digital platform and call centre.
Location
Location
Essen, Germany, 45355
Arms | Assigned Interventions |
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Prospective Cohort This prospective cohort study will include participants who receive the AZD1222 vaccine. Enrolment is permitted within 28 days of the first dose of AZD1222 and can be completed at the vaccination site or remotely. | - |
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