EU Secondary Data Post-Authorisation Safety Study of AZD1222

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

5321930 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-18

Study Completion Date

2024-01-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated With AZD1222

NCT04877743

Coronavirus Disease 2019 (COVID-19)

TERMINATED

AZD1222 Vaccine for the Prevention of COVID-19

NCT04540393

COVID-19

WITHDRAWN PHASE3

COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring

NCT04844632

Health Care Utilization Health Care Associated Infection

UNKNOWN

Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults

NCT04516746

COVID-19 SARS-CoV-2

COMPLETED PHASE3

COVID-19 Vaccines Safety Tracking (CoVaST)

NCT04834869

Adverse Reaction to Vaccine COVID19 Vaccine

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 in the matched population 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 in the matched population and 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 designs will be used.

Exploratory objectives: 1) To describe the IRs of prespecified AESIs in subjects who received an mRNA vaccine against COVID-19 (either Comirnaty or Spikevax) (active comparators) and in subjects from the pre-pandemic period (2017-2018) (historical comparators) in the matched population; 2) To estimate the relative and absolute risk of prespecified AESIs in subjects who received at least 1 dose of AZD1222 in the matched population compared with historical comparators in the matched population; and 3) To estimate the relative and absolute risk of prespecified AESIs in subjects who received 2 doses of AZD1222 in the matched population compared with subjects who received 2 doses of active comparator (Comirnaty or Spikevax as per homologous vaccination regimen) in the matched population\*

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19, Vaccine Adverse Events of Special Interest

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AZD1222

at least one dose of AZD1222

AZD1222

Intervention Type BIOLOGICAL

Covid-19 AstraZeneca Vaccine

comparator 1

concurrent unvaccinated

No interventions assigned to this group

comparator 2

historical controls

No interventions assigned to this group

comparator 3

active comparators\*

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

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD1222

Covid-19 AstraZeneca Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Have at least 12 months of data available before the index date
* Have no record of vaccination with any other COVID-19 vaccine on or before the index date

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

Exclusion Criteria

For each AESI, subjects (in any matched cohort) who had a specific AESI during the look-back period before the index date will be excluded from the cohort for the analysis of that specific AESI, but not from the cohorts for analysis of other AESIs.

\- If a subject had a specific AESI between the index date and the start of the risk window or had any censoring criteria within this time period, the subject will be excluded from the analysis of that specific AESI.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No