Influenza Infections and Infestations
Conditions
Interventions
Randomisation is via an online tool. Each group will receive both 0.2 ml of Fluenz (Live, attenuated influenza vaccine) via nasal spray and 0.2 ml of inert placebo via nasal spray, each as a single ad
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
12 Months to 2 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 12 months up until 1 day before their second birthday 2. Parent/legal guardian is willing and able to give written informed consent for participation in the trial 3. In good health as determined by a trial clinician. Participants may have well-controlled or mild-moderate comorbidity, specifically including a personal history of eczema, bronchiolitis or viral-induced wheeze 4. In the Investigator’s opinion, is able and willing to comply with all trial requirements 5. Willing to allow their General Practitioner and consultant, if appropriate, to be notified of participation in the trial 6. Willing to allow investigators to discuss the volunteer’s medical history with their General Practitioner and access all medical records when relevant to study procedures
Exclusion criteria
Exclusion criteria: 1. Previous receipt of an IM seasonal influenza vaccine 2. Receipt of any investigational vaccine other than the study intervention within 30 days before and after each study vaccination 3. Living in close contact with someone with a severely weakened immune system 4. Administration of immunoglobulins and/or any blood products within the 3 months preceding the planned administration of the vaccines 5. 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). 6. 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. 7. Any history of anaphylaxis 8. Current diagnosis of or treatment for cancer 9. 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 10. 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) 11. History of active or previous auto-immune neurological disorders (e.g. Guillain-Barre syndrome, transverse myelitis). 12. Scheduled elective surgery during the trial 13. Participants who have participated in another research trial involving an investigational product in the past 12 weeks. 14. Parent or guardian has an insufficient level of English language to undertake all study requirements in the opinion of the Investigators, except where translation has been able to be provided and is available. If at Visit 1 Screening & Vaccination, the volunteer has any of the following, they will not be enrolled that day. 15. Acute respiratory illness with or without wheeze (moderate or severe illness with or without fever) 16. Fever (oral temperature greater than 37.8°C) 17. Active wheezing at the time of dosing/randomisation (including use of bronchodilators within the past 72 hours). They may be considered for enrolment later in the trial if they recover in sufficient time
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| All cause medical attendances, measured by GP electronic records and electronic diaries in the 4 weeks post vaccine or placebo | — |
Primary
| Measure | Time frame |
|---|---|
| Medically attended wheeze, measured via GP SNOMed codes for "viral induced wheeze", "asthma", "wheeze", or a prescription for "salbutamol" or "ipratropium bromide" collected from the GP record in the 4 weeks post receipt of vaccine or placebo. Any medically attended wheeze events reported via the electronic diary will also be included. | — |
Countries
United Kingdom
Outcome results
None listed