Study on Influenza-Like Illnesses and Severe Influenza in adults
Research type
Research Study
Full title
An open-label multi-center enabling study to evaluate Influenza-Like Illnesses and Severe Influenza Disease in adults aged 65 years and above
IRAS ID
331804
Contact name
Ian Binnian
Contact email
Duration of Study in the UK
0 years, 7 months, 14 days
Research summary
Influenza infection is one of the main causes of infectious death in the world. Annual influenza vaccination is currently the most effective mean of controlling influenza, preventing its complications and mortality. In this study, we will check if patients have symptoms of Influenza during the cold season.
This study is being done on adults aged 65 and above to find out if they have flu symptoms during one cold season and in the case that they have flu symptoms, whether their illness is caused by the flu virus and, if yes, which version of it.
This is an enabling study funded by GSK that will be conducted in GP practices in the UK for approximately 6 months during the cold season. The findings on this study will help an upcoming phase 3 efficacy study that will assess the relative efficacy of a new influenza candidate vaccine in older adults. The patients will undergo physical examination, nasal/throat self-swabbing training, nasal/throat swabbing and questionnaires in the first site visit. They will have to fill in a diary with questions about their symptoms and return to the site in the end of the study for final assessments. Although there are just 2 scheduled visits, extra visits may be required if/when participants report having flu like symptoms.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0312
Date of REC Opinion
19 Sep 2023
REC opinion
Favourable Opinion