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VidPrevtyn Beta® vaccine effectiveness against COVID-19 hospitalisations in the UK

VidPrevtyn Beta® vaccine effectiveness against hospitalization due to SARS-CoV-2 infection – a secondary database study in the UK

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN95900937
Enrollment
617000
Registered
2023-07-24
Start date
2023-03-01
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Infections and Infestations

Interventions

This is an observational retrospective matched cohort study using a series of datasets in England, accessible through National Health Services (NHS) England (formerly NHS Digital). The overall study
groups at a greater risk of poor CO

Sponsors

Sanofi (France)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: This study will include all individuals aged 18 years or older who are eligible to receive a VidPrevtyn Beta vaccine.

Exclusion criteria

Exclusion criteria: Individuals <18 years and those who are ineligible to receive a VidPrevtyn Beta vaccine.

Design outcomes

Primary

MeasureTime frame
Vaccine effectiveness of VidPrevtyn Beta against hospitalisation due to laboratory-confirmed SARS-CoV-2 infection in patients who have received at least one additional dose of VidPrevtyn Beta as their last dose, compared with patients who have not received a booster dose measured using patient medical records within the same campaign period

Secondary

MeasureTime frame
Secondary outcome measures are measured using patient medical records: 1. Vaccine effectiveness of VidPrevtyn Beta against death due to laboratory-confirmed SARS-CoV-2 infection in patients who have received at least one additional dose of VidPrevtyn Beta as their last dose, compared with patients who have not received a booster dose within the same campaign period 2. Relative vaccine effectiveness of VidPrevtyn Beta against hospitalisation due to laboratory-confirmed SARS-CoV-2 infection in patients who have received at least one additional dose of VidPrevtyn Beta as their last dose, compared with patients who have received an mRNA booster dose within the same campaign period Exploratory outcome measures: 1. Vaccine effectiveness of VidPrevtyn Beta against hospitalisation due to laboratory-confirmed SARS-CoV-2 infection in patients who have received at least one additional dose of VidPrevtyn Beta as their last dose, compared with patients who have not received a booster dose within the same campaign period, stratified by: 1.1. Age groups 1.2. Gender 1.3. COVID-19 vaccination history 1.3.1. Compare by heterologous vs homologous (platform) history of vaccination 1.3.2. Compare by number of previous COVID-19 vaccine doses received 1.3.3. Subgroups of special interest (e.g. pregnant women, immunocompromised patients, frail patients with unstable health conditions and co-morbidities (eg, chronic obstructive pulmonary disease [COPD], diabetes, chronic neurological disease, cardiovascular disorders), patients with the autoimmune or inflammatory disorder)

Countries

England, United Kingdom

Contacts

Public ContactMark Yates
mark.yates@evidera.comNone provided

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026