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EU Secondary Data Post-Authorisation Safety Study of AZD1222

CompletedN/A

Sponsor: AstraZeneca

Conditions: COVID-19, Vaccine Adverse Events of Special Interest

Interventions: AZD1222

Countries: Netherlands, Spain, United Kingdom

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.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion criteria for AZD1222, unvaccinated, and active comparators\*:

* 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

Inclusion criteria for historical comparators:

\- 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

Locations (4)

Utrecht, Netherlands
Barcelona, Spain
Valencia, Spain
Southampton, United Kingdom