Oxford/AstraZeneca COVID-19 Vaccine Effectiveness in England (RAVEN)

Real-world Effectiveness of the Oxford/AstraZeneca COVID-19 Vaccine in England. An Observational Retrospective Cohort Study Using Secondary Databases to Establish Effectiveness of the Oxford/AstraZeneca COVID-19 Vaccine in England.

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.

Study Overview

• Status: Completed
• Conditions: Covid-19 Infection

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 18373714

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Concurrent Controls
Vaccinated Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence rate of COVID-19 related hospitalizations, COVID-19 related ICU admissions and COVID-19 related deaths	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Number of primary care consultations, prescriptions, medical tests and investigations, hospital outpatient attendances and procedures, hospital emergency department attendances without admission, hospital admissions	up to 12 months
Costs for COVID-19 related healthcare	Costs for primary care consultations, prescriptions, medical tests and investigations, hospital outpatient attendances and procedures, hospital emergency department attendances without admission, hospital admissions	up to 12 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: The Chancellor, Masters and Scholars of the University of Oxford

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): January 27, 2023
• Study Completion (Actual): January 27, 2023

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: D8111R00007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No