*AReSVi 006, Version 1 (212494)
Research type
Research Study
Full title
A Phase 3, randomized, placebo-controlled,observer-blind, multi-country study to demonstrate the efficacy of a single dose of GSK’s RSVPreF3 OA investigational vaccine in adults aged 60 years and above.
IRAS ID
269636
Contact name
Nell Wyatt
Contact email
Sponsor organisation
GSK
Eudract number
2020-000753-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 12 months, 31 days
Research summary
Respiratory Syncytial Virus (RSV) is a highly contagious virus that causes respiratory infections in people of all ages. Mild cases present like a common cold. RSV can lead to serious complications such as pneumonia in older adults. RSV may also worsen some existing conditions such as chronic respiratory or heart disease. Currently, there is no approved RSV vaccine.
This global research study, funded by GlaxoSmithKline, will evaluate if the investigational RSV vaccine can protect adults at least 60 years of age against RSV infection and further evaluate its safety. The study will also provide information about the consistency of three separate batches (lots) of this investigational vaccine.
Globally about 18000 adults aged 60 years and above living in the community or long term care facility (e.g. care homes, assisted living facilities) will be invited to take part in this research study which will be run in hospitals, GP or clinical research centres. In the UK, about 1650 participants will be recruited.
Participants will undergo a range of clinical assessments and safety monitoring. There will be 4 or 5 visits and several contacts (phone calls, emails) over 2.5 or 3 years depending, on trial location.
All participants will receive a single dose of either investigational RSV vaccine or placebo (a dummy vaccine) and be asked to report any reactions experienced after vaccination. Blood samples will be taken to see how well the immune system is responding to vaccine.
Starting one month after vaccination all participants will be regularly contacted to check if they are experiencing a respiratory illness. If present, the participant will have an additional visit, a nasal and throat swab taken and asked to complete health questionnaires.
The lay summary of results will be available on trial summaries on or before 28 Jun 2025. Sponsor will provide confirmation to HRA via email once the lay summary is confirmed published.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: The lay summary will be posted within 12 months of study closure, on or before 28 Jun 2025.REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0295
Date of REC Opinion
5 Feb 2021
REC opinion
Further Information Favourable Opinion