Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)

Data collection methods

Combined primary data collection and secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

COVID-19 immunisation
Population studied

Short description of the study population

Participants are eligible to be included in the study only if all the following criteria apply:
 Aged 18 or older at the time of vaccination.
 Received AZD1222 as the first dose of COVID-19 vaccination in the prior 28 days.
 The participant has provided sufficient details to validate the vaccination (vaccination card, batch/lot number, and/or regional vaccination register details).
 Provided informed consent to participate in the study, either personally or through a legal representative.
 Able and willing to provide responses to study notifications using the mobile device app, web portal, or call centre or have a proxy (a caregiver, family member, or other trusted individual) who can do so on their behalf.
 Able and willing to grant, personally or through a legal representative, permission to contact the participant’s healthcare providers and to access the participant’s medical records at the time of vaccination and during the post-vaccination follow-up period.

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Special population of interest

Immunocompromised
Pregnant women

Estimated number of subjects

15000
Study design details

Main study objective

The primary objective of the study is to estimate the incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), and medically-attended adverse events following immunisation (AEFIs) after at least one intramuscular (IM) dose of AZD1222 for 3 months after vaccination.

Outcomes

Number of participants with SAEs, AESIs and medically-attended AEFIs with AZD1222 for 3 months after vaccination, -Number of participants with SAEs, AESIs and medically-attended AEFIs with AZD1222 for up to 18 months after vaccination -Number of participants with SAEs, AESIs and medically-attended AEFIs with AZD1222 categorised by age group -Number of participants with select comorbidities with SAEs, AESIs and medically-attended AEFIs with AZD1222 and more (not enough space to fullfil)

Data analysis plan

This study is descriptive in nature. Distribution of participant characteristics at baseline will be described through point estimates (mean, median, rates or proportions) and the corresponding variability (interquartile range, 95% confidence intervals). The primary analysis will only include participants who enrolled within 7 days of vaccination with the first dose of AZD1222. For the primary and secondary analyses, the cumulative incidence of each outcome measure will be computed as the proportion of participants who reported an event among all AZD1222-vaccinated participants who completed each study-defined follow-up interval, as well as among all AZD1222-vaccinated participants regardless of completion status, in combination with corresponding patient-years. Where feasible, incidence rates will be calculated. Subgroup evaluations and sensitivity analyses will also be performed.