Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 Study
NCT ID: NCT02111512
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
PHASE4
779 participants
INTERVENTIONAL
2014-09-30
2015-03-31
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 published data on the safety of LAIV in egg-allergic children. In SNIFFLE 1 Study, 433 doses were given to 282 egg-allergic children; data is currently being analysed.
The objective of this multicentre study is to further 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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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Egg allergic children
Children with a physician diagnosis of egg allergy will be recruited to receive the intranasal LAIV as part of a safety surveillance study
Administration of Live attenuated influenza vaccine (LAIV)
Interventions
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Administration of Live attenuated influenza vaccine (LAIV)
Eligibility Criteria
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Inclusion Criteria
* Physician-diagnosis of egg allergy
Exclusion Criteria
2. Contraindications to LAIV (notwithstanding allergy to egg protein):
* Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)
* Previous systemic allergic reaction to LAIV
* Previous allergic reaction to an influenza vaccine (not LAIV) is a relative contra-indication, which must be discussed with the site PI to confirm patient suitability
* Children/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. NB: LAIV is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.
* 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.
3. Contraindication to vaccination on that occasion, due to child being acutely unwell:
* Febrile ≥38.0oC in last 72 hours
* Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child's treating healthcare professional
* Recent admission to hospital in last 2 weeks for acute asthma
* Current oral steroid for asthma exacerbation or course completed within last 2 weeks
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
Principal Investigators
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Mich Erlewyn-Lajeunesse, DM FRCPCH
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Southampton NHS Foundation Trust
Paul J Turner, FRACP PhD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Ulster Hospital
Belfast, Northern Ireland, United Kingdom
Royal United Hospital Bath NHS Trust
Bath, , United Kingdom
Sandwell General Hospital
Birmingham, , United Kingdom
Bristol Royal Hospital for Children
Bristol, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
Royal Hospital for Sick Children
Edinburgh, , United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, , United Kingdom
Wye Valley NHS Trust
Hereford, , United Kingdom
Cambridgeshire Community Services NHS Trust (Hinchingbrooke Hospital)
Huntingdon, , United Kingdom
Leeds Children's Hospital
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Alder Hey Children's Hospital
Liverpool, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Evelina Children's Hospital
London, , United Kingdom
Imperial College Healthcare NHS Trust (St. Mary's Hospital)
London, , United Kingdom
Kings College Hospital NHS Foundation Trust
London, , United Kingdom
London St George's Hospital
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Luton and Dunstable Hospital
Luton, , United Kingdom
Manchester Royal Children's
Manchester, , United Kingdom
Newcastle Freeman Hospital
Newcastle, , United Kingdom
Oxford
Oxford, , United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, , United Kingdom
Sheffield Children's Hospital NHS Foundation Trust
Sheffield, , United Kingdom
Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, , United Kingdom
University Hospitals Southampton NHS Foundation Trust
Southampton, , United Kingdom
Warrington & Halton Hospitals NHS Foundation Trust
Warrington, , United Kingdom
Hampshire Hospital NHS Foundation Trust
Winchester, , United Kingdom
Countries
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References
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Turner PJ, Southern J, Andrews NJ, Miller E, Erlewyn-Lajeunesse M; SNIFFLE-2 Study Investigators. Safety of live attenuated influenza vaccine in young people with egg allergy: multicentre prospective cohort study. BMJ. 2015 Dec 8;351:h6291. doi: 10.1136/bmj.h6291.
Other Identifiers
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2014-001537-92
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17189
Identifier Type: REGISTRY
Identifier Source: secondary_id
RHM CHI 0714
Identifier Type: -
Identifier Source: org_study_id
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