Oxford/AstraZeneca COVID-19 Vaccine Effectiveness in England

Covid-19 Infection Clinical Trial

— RAVEN  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05047822
• Other study ID #: D8111R00007
• Status: Completed
• Start date: August 23, 2021
• Est. completion date: January 27, 2023

Study information

• Verified date: November 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18373714
• Est. completion date: January 27, 2023
• Est. primary completion date: January 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid-19 Infection

Locations

Country	Name	City	State
United Kingdom	Research Site	Leeds

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	The Chancellor, Masters and Scholars of the University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of COVID-19 related hospitalizations, COVID-19 related ICU admissions and COVID-19 related deaths		up to 12 months
Secondary	Incidence rate of all-cause hospitalisations, all-cause ICU admissions and all-cause deaths		up to 12 months
Secondary	Incidence of positive SARS-CoV-2 test		up to 12 months
Secondary	Incidence of medically attended COVID-19		up to 12 months
Secondary	Incidence of COVID-19 related emergency department visit		up to 12 months
Secondary	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
Secondary	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

External Links

•   CSR Synopsis