D8111R00006: EU Secondary Data Post-Authorisation Safety Study of AZD1222
Study Details
Study Description
Brief Summary
A study based on electronic heath records will evaluate the incidence and relative risk of safety concerns and adverse events of special interest (AESIs) following immunisation by AZD1222 in the real-world setting.
A cohort and a self-controlled case series desings will be used.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This retrospective study based on electronic heath records will evaluate the incidence and relative risk of safety concerns and adverse events of special interest (AESIs) following immunisation by AZD1222 in the real-world setting. The primary study objectives are to (1) describe baseline characteristics of all individuals who receive at least one dose of AZD1222 over the study period; (2) describe, among subjects who receive a first dose of AZD1222, the timing and type of second dose of any COVID-19 vaccine over the study period; (3) describe the incidence of prespecified AESIs in subjects who have received at least one dose of AZD1222 and in matched unvaccinated subjects; and (4) estimate any increased risk of prespecified AESIs following vaccination with AZD1222 using study retrospective cohort and self-controlled risk interval designs. Secondary objectives are identical to the primary, although focused on specific populations considered to have missing information, specifically (a) women who are pregnant or breastfeeding, (b) immunocompromised patients, (b) frail patients with certain comorbidities, (c) patients with autoimmune or inflammatory disorders, and (d) patients who, at cohort entry, had recently received a number of selected vaccines to prevent diseases other than COVID-19. A cohort and a self-controlled case series desings will be used.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| AZD1222 at least one dose of AZD1222 |
Biological: AZD1222
Covid-19 AstraZeneca Vaccine
|
| comparator non vaccinated |
Outcome Measures
Primary Outcome Measures
- Adverse events of special interest [up to 365 days]
several AESIs
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have at least 12 months of data available before cohort entry
-
Have no record of vaccination with any SARS-CoV-2 vaccine on or before the date of cohort entry
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Firenze | Italy | 50141 | |
| 2 | Research Site | Utrecht | Netherlands | 3528 AE | |
| 3 | Research Site | Barcelona | Spain | 8007 | |
| 4 | Research Site | Valencia | Spain | 46020 | |
| 5 | Research Site | Southampton | United Kingdom | SO31 1AA |
Sponsors and Collaborators
- AstraZeneca
- RTI Health Solutions
Investigators
- Principal Investigator: Cristina Rebordosa, MD, PhD, RTI
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D8111R00006