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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Saul
Faust
s.faust@soton.ac.uk
Mrs
Sharon
Davies-Dear
sharon.davies-dear@uhs.nhs.uk
Helena
Walsh
helena.walsh@umed.io
Alasdair
Munro
a.munro@soton.ac.uk
Ben
Wilson
benjamin.wilson@uhs.nhs.uk
Influenza and pneumonia
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Influenza (known as flu) causes substantial illness every winter,especially among older-people,those with weakened immune systems,and young children. The NHS currently offers a nasal flu vaccine to children over 2 years,which also helps protect others by reducing transmission. Although children under 2 years are highest risk from flu,they haven’t yet been offered the vaccine as sufficient safety data was not available for this age.
What we’re doing
â—Ź We will recruit 12- to 23-month-old children at their GP practice and randomly assign them to receive the nasal flu vaccine or a placebo nasal spray at their first visit. The parents will not know which one the child receives.
â—Ź Over the next four weeks,we will record/monitor the number of children in each group return to their GP with a wheezing diagnosis.
â—Ź At the second visit,each child will receive whichever nasal spray they did not get at the first visit. Rates of wheezing will then again be compared after the second visit.
â—Ź Every child will receive both the vaccine and a placebo.
If the rate of wheezing after the vaccine is the same (or lower) than after the placebo,the UK’s vaccination advisory committee may decide to offer the nasal flu vaccine to all children from 12 months of age next winter.
This trial will be conducted with a company called uMed,a clinical research technology platform,who partners with UK Healthcare Providers to access NHS Electronic Health Record data and invite patients to participate in research. The uMed system was used in the HARMONIE study of nirsevimab (preventing RSV in infants) performed in general practice and hospitals in autumn 2022. uMed will be involved in aspects including digital screening & invitations,remote eConsent and electronic monitoring,ensuring it runs efficiently.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Vaccine;
You can take part if:
You may not be able to take part if:
•Previous receipt of an IM seasonal influenza vaccine •Receipt of any investigational vaccine other than the study intervention within 30 days before and after each study vaccination. •Living in close contact with someone with a severely weakened immune system. •Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines. •Children eligible for annual influenza immunisation according to the national NHS programme,including those with any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months,except topical steroids or short-term oral steroids (course lasting ≤14 days). •History of allergic disease or reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to gentamicin,gelatin,or other ingredients of Fluenz). Allergy to egg is only a contraindication if the participant has previously had anaphylaxis to egg. •Any history of anaphylaxis. •Current diagnosis of or treatment for cancer •Any other significant disease,disorder or finding which may significantly increase the risk to the volunteer because of participation in the study,affect the ability of the volunteer to participate in the study or impair interpretation of the study data. •Severe and/or uncontrolled cardiovascular disease,respiratory disease,gastrointestinal disease,liver disease,renal disease,endocrine disorder and neurological illness,defined broadly as currently requiring frequent hospital/specialist input or recently resulting in hospital admission,or as determined by the investigator (mild/moderate well controlled comorbidities are allowed). •History of active or previous auto-immune neurological disorders (e.g. Guillain-Barre syndrome,transverse myelitis). •Scheduled elective surgery during the trial •Children receiving salicylate therapy (i.e.,aspirin) •Participants who have received an investigational product,or participated in another research trial involving an investigational product in the past 12 weeks or 5 half-lives after the last IMP dose (whichever is longer) before the first dose of study treatment. •Parent or guardian has insufficient level of English language to undertake all study requirements in opinion of the Investigators except where translation has been able to be provided and is available.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Helena
Walsh
helena.walsh@umed.io
Alasdair
Munro
a.munro@soton.ac.uk
Ben
Wilson
benjamin.wilson@uhs.nhs.uk
Dr
Saul
Faust
s.faust@soton.ac.uk
Mrs
Sharon
Davies-Dear
sharon.davies-dear@uhs.nhs.uk
The study is sponsored by UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST and funded by NIHR Central Commissioning Facility (CCF) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 69981
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