Oxford/AstraZeneca COVID-19 Vaccine Effectiveness in England
- Conditions
- Covid-19 Infection
- Registration Number
- NCT05047822
- Lead Sponsor
- AstraZeneca
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18373714
- 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
• People with a history of COVID-19 infection (confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or not) prior index date
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence rate of COVID-19 related hospitalizations, COVID-19 related ICU admissions and COVID-19 related deaths up to 12 months
- Secondary Outcome Measures
Name Time Method Incidence rate of all-cause hospitalisations, all-cause ICU admissions and all-cause deaths up to 12 months Incidence of COVID-19 related emergency department visit up to 12 months Costs for COVID-19 related healthcare 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
COVID-19 related healthcare resource utilisation 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
Incidence of medically attended COVID-19 up to 12 months Incidence of positive SARS-CoV-2 test up to 12 months
Trial Locations
- Locations (1)
Research Site
🇬🇧Leeds, United Kingdom