Oxford/AstraZeneca COVID-19 Vaccine Effectiveness in England

NCT ID: NCT05047822

Last Updated: 2023-11-18

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

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Recruitment Status

COMPLETED

Total Enrollment

18373714 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-23

Study Completion Date

2023-01-27

Brief Summary

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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.

Detailed Description

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The United Kingdom (UK) is one of the first countries that introduced a mass vaccination campaign for COVID-19 and vaccination of the adult population first focused on the oldest age groups, their carers and health care workers (JCVI, 2020). Three COVID-19 vaccines were licensed and are being used including the Moderna, the BioNTech/Pfizer, and the Oxford/AstraZeneca vaccines. Vaccination with the BioNTech/Pfizer vaccine started in December 2020 and the Oxford/AstraZeneca vaccine started in early January 2021. This study is to primarily assess the effectiveness of the Oxford/AstraZeneca COVID-19 vaccine. Given the known high efficacy of the mRNA vaccines in randomized controlled trials (RCTs) and real-world evidence studies, the study aims also to evaluate the vaccine effectiveness (VE) of other COVID-19 vaccines as a validation of the study's methods. On 16 September 2021 it was announced that Booster doses would be introduced in the UK to address vaccine waning and for groups with a suboptimal response. Little is known about health care resource utilisation (HCRU) and health care costs for those who have had COVID-19 or by individual clinical risk group. The RAVEN study 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. Analyses will examine the effectiveness of one and two doses, and booster or other additional doses if applicable. This study's extension (October 2021) adds a more detailed exploration of VE in risk groups and an evaluation of the HCRU by people with COVID-19 compared with those who are vaccinated.

Conditions

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Covid-19 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Concurrent Controls

No interventions assigned to this group

Vaccinated Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Chancellor, Masters and Scholars of the University of Oxford

UNKNOWN

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D8111R00007

Identifier Type: -

Identifier Source: org_study_id

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