EU Secondary Data Post-Authorisation Safety Study of AZD1222

NCT05126992 | Completed

• 1 other identifier: D8111R00006
• Study Type: observational
• Target: 5,321,930
• Locations: 3 countries
• Sites: 4

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.

Conditions

COVID-19, Vaccine Adverse Events of Special Interest

Keywords

AZD1222; ChAdOx1nCoV-19; Vaccine 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

AZD1222 BIOLOGICAL

Covid-19 AstraZeneca Vaccine

AZD1222

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• RTI Health Solutions: collaborator

Study Sites (4)

Research Site

Utrecht, 3528 AE, Netherlands

Location

Research Site

Barcelona, 8007, Spain

Location

Research Site

Valencia, 46020, Spain

Location

Research Site

Southampton, SO31 1AA, United Kingdom

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

COVID-19

Interventions

ChAdOx1 nCoV-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines, DNA; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines

Study Officials

• Cristina Rebordosa, MD, PhD

  RTI

  PRINCIPAL INVESTIGATOR

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
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

GB (1); NL (1); ES (2)