[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563747":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":59,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LAIV","EXPERIMENTAL",null,[13],"Biological: FLUENZ",{"label":15,"type":10,"description":11,"interventionNames":16},"IAV Challenge",[17],"Biological: Influenza challenge virus",[19,26],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","FLUENZ","LAIV (Intranasal Influenza Vaccine)",[9],[25,9],"Influenza vaccine",{"type":20,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"Influenza challenge virus","Influenza challenge virus (H3N2 strain)",[15],[31],{"name":32,"affiliation":5,"role":33},"Christopher Chiu","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Polly Fox, MSc","CONTACT","0208383 3231","polly.fox@imperial.ac.uk",[41],{"facility":42,"status":43,"city":44,"state":11,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Imperial Clinical Research Facility, Imperial College Healthcare NHS Trust","RECRUITING","London","W12 0HS","United Kingdom","UK",{"type":49,"coordinates":50},"Point",[51,52],-0.12574,51.50853,{"lat":52,"lon":51},[55,58],{"name":56,"role":37,"phone":11,"phoneExt":11,"email":57},"Polly Fox","imperial.humanchallenge@nhs.net",{"name":32,"role":33,"phone":11,"phoneExt":11,"email":11},{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[62],{"name":63,"class":6},"Imperial College Healthcare NHS Trust","100563747","generating-mucosal-immunity-after-influenza-infection-and-vaccination-in-lung-and-lymphoid-tissue-100563747",false,"NCT06620185","GEneRating Mucosal Immunity After INfluenzA Infection and Vaccination in Lung and Lymphoid TissuE","A Two-arm, Non-randomised, Open-label Experimental Medicine Study to Compare Immune Responses Between Healthy Volunteers Aged 18-55years Receiving Either an Intranasal Live-attenuated Influenza Vaccine or Viral Challenge With GMP Influenza A\u002FBelgium\u002F4217\u002F2015 (H3N2)","GERMINATE","Inclusion Criteria:\n\n* Adults aged between 18-55 years inclusive\n* Sero-suitable as defined by a serum micro-neutralisation titre \\\u003C1:20\n* Female participant who is not of child-bearing potential as assessed by an investigator OR is willing and able to use contraception as described in the protocol\n* Male participants who are willing to use one of the contraception methods described in the protocol\n* In good health with no clinically significant medical conditions\n\nExclusion Criteria\n\n* History of clinically significant\u002Fcurrently active conditions;\n\n  * Cardiovascular, thromboembolic\u002Fcerebrovascular disease.\n  * Types of chronic respiratory disease in adulthood.\n  * Significant wheeze in the past\n  * Respiratory symptoms including wheeze, resulting in hospitalisation\n  * Known bronchial hyperactivity to viruses\n  * Diabetes mellitus\n  * Migraine with associated symptoms like hemiplegia\u002Fvision loss. Cluster headache\u002Fmigraine\u002Fprophylactic treatment for migraine.\n  * History of autoimmune disease\u002Fknown immunodeficiency of any cause\n  * Immunosuppression.\n  * Known coagulation disorder\u002Fanticoagulant therapy\n  * Psychiatric illness including participants with a history of depression and\u002For anxiety with associated psychiatric comorbidities\n  * Other major disease that, under the PI's discretion, could interfere with the participant completing the study.\n* Concurrent serious illness including history of malignancy that could interfere with the study or a participant completing the study.\n* Known IgA deficiency\u002Fimmotile cilia syndrome\u002FKartagener's syndrome\n* Significant abnormality altering the anatomy\u002Ffunction of the nose or nasopharynx, a clinically significant history of epistaxis within the last 3 months, nasal\u002Fsinus surgery within 6 months of Day 0, including nasopharyngeal malignancy, arterio-venous malformation, or undiagnosed nasopharyngeal mass\n* Inhaled bronchodilator\u002Finhaled steroid use within the last 12 months before Day 0\n* Acute upper respiratory tract infection in the past 6 weeks.\n* Receipt of systemic glucocorticoids (in a dose ≥ 5 mg prednisone daily or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within 6 months before Day 0\n* Receipt of any vaccine within 30 days of Day -14\n* Any significant medical condition\u002Fprescribed drug, under the PI's discretion\n* Presence of cold-like symptoms and\u002For fever on Day -14 or Day 0.\n* Receipt of blood\u002Fblood products\u002Floss (including blood donations) of 550 mL or more of blood during the 3 months prior to Day -14.\n* Significant history\u002Fpresence of drug\u002Falcohol misuse by self-report.\n* Current use of drugs through nose inhalation or inhaled route including recreational drugs.\n* Regular smoking and\u002For vaping and\u002For using nicotine-containing products in the past 3 months OR \\>5 pack-year lifetime history by self-report (5 pack years is equivalent to one pack of 20 cigarettes per day for 5 years).\n* History of anaphylaxis and\u002For a history of severe allergic reaction or significant intolerance to any food\u002Fdrug, as assessed by the PI.\n* Clinically active rhinitis (including hay fever)\u002Fhistory of moderate to severe rhinitis\u002Fhistory of seasonal allergic rhinitis likely to be active at the time of inclusion into the study and\u002For requiring regular nasal corticosteroids on an at least weekly basis, within 30 days of enrolment.\n* Anyone with any of the following contraindications to receiving the Fluenz Tetra Vaccine:\n\n  * Allergy to gentamicin, gelatin or the other ingredients of the fluenz vaccine.",true,"ALL","18 Years","55 Years",{"count":77,"type":78},36,"ESTIMATED","INTERVENTIONAL",[81],"NA","This experimental medicine study aims to compare immune responses in healthy adult volunteers aged 18-55 years against influenza vaccination and infection in the upper and lower respiratory tract, following administration of a live-attenuated influenza vaccine delivered by nasal spray versus influenza A (H3N2) viral challenge.",[84],"Influenza",[9,86,87,84,88],"Challenge","Vaccine","Flu","2026-04-15",{"date":91,"type":92},"2026-04-20","ACTUAL",{"date":94,"type":92},"2025-04-16",{"date":96,"type":78},"2026-07-31",{"name":5,"class":6},1]