NCT05047822

Brief Summary

This is a retrospective cohort study to assess the real world effectiveness of the Oxford/AstraZeneca COVID-19 vaccine in England. The study is using linkage of the English national databases on COVID-19 vaccination, testing, medical records, hospitalization, and death.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,373,714

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

August 27, 2021

Last Update Submit

November 16, 2023

Conditions

Covid-19 Infection

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of COVID-19 related hospitalizations, COVID-19 related ICU admissions and COVID-19 related deaths

    up to 12 months

Secondary Outcomes (6)

  • Incidence rate of all-cause hospitalisations, all-cause ICU admissions and all-cause deaths

    up to 12 months

  • Incidence of positive SARS-CoV-2 test

    up to 12 months

  • Incidence of medically attended COVID-19

    up to 12 months

  • Incidence of COVID-19 related emergency department visit

    up to 12 months

  • COVID-19 related healthcare resource utilisation

    up to 12 months

  • +1 more secondary outcomes

Study Arms (2)

Concurrent Controls

Vaccinated Cohort

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

12 years old or older population in England who met inclusion criteria

You may qualify if:

  • Eligible for any COVID-19 vaccination based on age at index date
  • Have continuous data coverage for the COVID-19 infection datasets
  • Have continuous data coverage in other linked databases for a minimum of 12 months prior to the index date

You may not qualify if:

  • People with a history of COVID-19 infection (confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or not) prior index date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Leeds, United Kingdom

Location

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 17, 2021

Study Start

August 23, 2021

Primary Completion

January 27, 2023

Study Completion

January 27, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

GB(1)