Safety of Nasal Influenza Immunisation in Egg Allergic Children
NCT ID: NCT01859039
Last Updated: 2020-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
282 participants
OBSERVATIONAL
2013-09-30
2014-02-28
Brief Summary
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A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been approved by a number of licensing boards and is given by a spray into the nose. This new vaccine has been available in the United States for several years and is highly effective and against influenza infection, with an excellent safety profile in children without egg allergy. However, LAIV is also grown in hen's eggs and contains egg protein, and there are NO existing data on the safety of LAIV in egg-allergic children.
The objective of this multicentre study is to assess the safety of intranasal LAIV in egg-allergic children, in order to demonstrate that these children can safely be given the new LAIV within a primary care health environment.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Egg allergic children
Administration of Live attenuated influenza vaccine
Administration of Live attenuated influenza vaccine
Interventions
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Administration of Live attenuated influenza vaccine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Physician-diagnosis of egg allergy
Exclusion Criteria
* Use of asthma reliever medication in last 72 hours
* Recent administration of a medication containing antihistamine within the last 4 days
* Current oral steroid for asthma exacerbation or course completed within last 2 weeks
* Contraindications to ingredient in LAIV (notwithstanding allergy to egg protein)
* Previous allergic reaction to an influenza vaccine
* Children and adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids.
* Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.
2 Years
17 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Public Health England
OTHER_GOV
University Hospital Southampton NHS Foundation Trust
OTHER
Responsible Party
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Paul Turner
MRC Clinician Scientist in Paediatric Allergy & Immunology
Principal Investigators
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Paul J Turner, FRACP PhD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Mich Erlewyn-Lajeunesse, DM FRCPCH
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Southampton NHS Foundation Trust
Locations
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Sandwell General Hospital
Birmingham, , United Kingdom
Bristol Royal Hospital for Children
Bristol, , United Kingdom
Royal Hospital for Sick Children
Edinburgh, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Alder Hey Children's Hospital
Liverpool, , United Kingdom
Evelina Children's Hospital
London, , United Kingdom
Imperial College Healthcare NHS Trust (St. Mary's Hospital)
London, , United Kingdom
London St George's Hospital
London, , United Kingdom
Manchester Royal Children's
Manchester, , United Kingdom
Newcastle Freeman Hospital
Newcastle, , United Kingdom
Oxford
Oxford, , United Kingdom
University Hospitals Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
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References
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Turner PJ, Southern J, Andrews NJ, Miller E, Erlewyn-Lajeunesse M; SNIFFLE Study Investigators. Safety of live attenuated influenza vaccine in atopic children with egg allergy. J Allergy Clin Immunol. 2015 Aug;136(2):376-81. doi: 10.1016/j.jaci.2014.12.1925. Epub 2015 Feb 13.
Other Identifiers
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RHM CHI 0659
Identifier Type: -
Identifier Source: org_study_id
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