Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 Study
SNIFFLE-2
Phase 4 Study to Assess the Safety of Nasal Influenza Immunisation in Egg Allergic Children - a Multicentre Observational Study
3 other identifiers
interventional
779
1 country
29
Brief Summary
Egg allergy is common in early childhood, affecting at least one in 50 preschool children. Influenza ("'flu") vaccines contain egg protein, as the vaccine is cultured in hen's eggs. There is robust data to support the safety of influenza vaccines (containing low or negligible amounts of egg protein) in patients with egg allergy. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2014
Shorter than P25 for phase_4
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2014
CompletedFirst Posted
Study publicly available on registry
April 11, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedAugust 10, 2020
August 1, 2020
5 months
April 4, 2014
August 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of allergic reaction to nasal influenza vaccination using a Live Attenuated Influenza Vaccine (LAIV) in egg-allergic children
Within 2 hours of vaccine administration
Secondary Outcomes (2)
Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children
72 hours after vaccine administration
Asthma control test
4 weeks post LAIV
Other Outcomes (1)
Incidence of immediate allergic reaction to LAIV in the subgroups described below.
Within 2 hours of vaccine administration
Study Arms (1)
Egg allergic children
OTHERChildren with a physician diagnosis of egg allergy will be recruited to receive the intranasal LAIV as part of a safety surveillance study
Interventions
Eligibility Criteria
You may qualify if:
- Aged 2 - 17 years old
- Physician-diagnosis of egg allergy
You may not qualify if:
- Clinical resolution of egg allergy
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Southampton NHS Foundation Trustlead
- Imperial College Londoncollaborator
- Public Health Englandcollaborator
Study Sites (29)
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
Related Publications (1)
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.
PMID: 26645895RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mich Erlewyn-Lajeunesse, DM FRCPCH
University Hospitals Southampton NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
Paul J Turner, FRACP PhD
Imperial College London
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MRC Clinician Scientist
Study Record Dates
First Submitted
April 4, 2014
First Posted
April 11, 2014
Study Start
September 1, 2014
Primary Completion
February 1, 2015
Study Completion
March 1, 2015
Last Updated
August 10, 2020
Record last verified: 2020-08