Trials Sponsors Conditions Drugs Pricing

Conditions

COVID-19, Vaccine Adverse Events of Special Interest

Keywords

AZD1222ChAdOx1nCoV-19Vaccine Adverse Events of Special Interest

Outcome Measures

Primary Outcomes (1)

Adverse events of special interest
several AESIs
up to 365 days

Study Arms (4)

AZD1222

at least one dose of AZD1222

Biological: AZD1222

comparator 1

concurrent unvaccinated

comparator 2

historical controls

comparator 3

active comparators\* \*Feasibility of the active comparator analysis will be assessed prior to conducting the analysis to ensure comparability between groups

Interventions

AZD1222Biological

Covid-19 AstraZeneca Vaccine

AZD1222

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The study population will include subjects who are exposed to the AZD1222 vaccine and 3 comparator groups: concurrent subjects who have not received any SARS-CoV-2 vaccine, historical controls, and active comparators\* \*Feasibility of the active comparator analysis will be assessed prior to conducting the analysis to ensure comparability between groups

You may qualify if:

Have at least 12 months of data available before the index date

Sponsors & Collaborators

RTI Health Solutions
Othercollaborator
AstraZeneca
Industrylead

Study Sites (4)

Research Site

Utrecht, 3528 AE, Netherlands

Research Site

Barcelona, 8007, Spain

Research Site

Valencia, 46020, Spain

Research Site

Southampton, SO31 1AA, United Kingdom

MeSH Terms

Conditions

COVID-19

Interventions

ChAdOx1 nCoV-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Study Officials

Cristina Rebordosa, MD, PhD
RTI
PRINCIPAL INVESTIGATOR

Enrollment

5,321,930 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 9, 2021

First Posted

November 19, 2021

Study Start

February 18, 2022

Actual (reported)

EU Secondary Data Post-Authorisation Safety Study of AZD1222

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

AZD1222

comparator 1

comparator 2

comparator 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

AZD1222

comparator 1

comparator 2

comparator 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations