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Completed

NCT Number: NCT05047822

Oxford/AstraZeneca COVID-19 Vaccine Effectiveness 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.

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Key information

Conditions

COVID-19 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Leeds, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: up to 12 months

Secondary outcomes

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

    Time frame: up to 12 months

  2. Incidence of positive SARS-CoV-2 test

    Time frame: up to 12 months

  3. Incidence of medically attended COVID-19

    Time frame: up to 12 months

  4. Incidence of COVID-19 related emergency department visit

    Time frame: up to 12 months

  5. COVID-19 related healthcare resource utilisation

    Time frame: up to 12 months

    Number of primary care consultations, prescriptions, medical tests and investigations, hospital outpatient attendances and procedures, hospital emergency department attendances without admission, hospital admissions

  6. Costs for COVID-19 related healthcare

    Time frame: up to 12 months

    Costs for primary care consultations, prescriptions, medical tests and investigations, hospital outpatient attendances and procedures, hospital emergency department attendances without admission, hospital admissions

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • The Chancellor, Masters and Scholars of the University of Oxford

Registry information

Official study title

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.

Acronym: RAVEN

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 17, 2021
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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