Status: Ongoing First registered on: 07/10/2021
Last updated on: 12/05/2023
1. Study identification
EU PAS Register NumberEUPAS43556
Official titleA 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)
Study title acronym
Study typeObservational study
Brief description of the studyAstraZeneca 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableClinicalTrials.gov Identifier: NCT05126992; https://clinicaltrials.gov/ct2/show/NCT05126992?term=NCT05126992&draw=2&rank=1
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagehttps://www.rtihs.org/services/pharmacoepidemiology-and-risk-management
Details of (Primary) lead investigator
Title Dr
Last name Rebordosa
First name Cristina
Is this study being carried out with the collaboration of a research network?
Yes

VAC4EU
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?7

IDIAPJGol
UMCU
PHARMO Institute
DSRU
RTI-HS
ARS
Foundation for the Promotion of Health and Biomedical Research of the Valencia Region (FISABIO), Spain
Countries in which this study is being conducted
International study

Italy
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed09/08/202107/09/2021
Start date of data collection17/02/202218/02/2022
Start date of data analysis
Date of interim report, if expected22/04/202226/04/2022
Date of final study report25/06/2024
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca AB100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Rebordosa
First name Cristina
Address line 1Av. Diagonal, 605, 9-1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain
Phone number (incl. country code)34933622807 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address crebordosa@rti.org
Public Enquiries
Title Dr 
Last name Rebordosa 
First name Cristina 
Address line 1Av. Diagonal, 605, 9-1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain 
Phone number (incl. country code)34933622807 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address crebordosa@rti.org 
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