Study identification

PURI

https://redirect.ema.europa.eu/resource/48711

EU PAS number

EUPAS43556

Study ID

48711

Official title and acronym

A post-authorisation/post-marketing observational study to evaluate the association between exposure to AZD1222 and safety concerns using existing secondary health data sources (COVID-19)

DARWIN EU® study

No

Study countries

Italy
Netherlands
Spain
United Kingdom

Study description

AstraZeneca developed vaccine AZD1222 to prevent COVID-19 (called Vaxzevria® in Europe). Based on the EU RMP, safety concerns for AZD122 include nervous system disorders (including immune-mediated neurological conditions), vaccine-associated enhanced disease (including vaccine-associated enhanced respiratory disease), thrombocytopenia with associated bleeding, anaphylaxis, thrombosis, and ‘thrombosis with thrombocytopenia syndrome’ (TTS). This PASS will evaluate the incidence and relative risk of safety concerns and adverse events of special interest (AESIs) following immunisation 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.

Study status

Finalised
Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
InstitutionNot-for-profitENCePP partner

Networks

Contact details

Cristina Rebordosa

Primary lead investigator
ORCID number:
0000-0002-8064-5997
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AstraZeneca AB
Study protocol
Initial protocol

d8111r00006-pass-clinical-study-protocol_Redacted

English (1.35 MB - PDF)View document
Updated protocol

D8111R00006_Protocol v4.0 Redacted (Apr23)

English (1.79 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)