Safety of Nasal Influenza Immunisation in Egg Allergic Children
SNIFFLE
Phase 4 Study to Assess the Safety of Nasal Influenza Immunisation in Egg Allergic Children - a Multicentre Observational Study
1 other identifier
observational
282
1 country
12
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2013
Shorter than P25 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedAugust 10, 2020
August 1, 2020
5 months
May 17, 2013
August 6, 2020
Conditions
Keywords
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 (1)
Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children
72 hours after vaccine administration
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
Administration of Live attenuated influenza vaccine
Interventions
Eligibility Criteria
Children and young people with egg allergy between 2-17 years old
You may qualify if:
- Aged 2 - 17 years old
- Physician-diagnosis of egg allergy
You may not qualify if:
- Contraindicated as acutely unwell or current unstable asthma
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Southampton NHS Foundation Trustlead
- Imperial College Londoncollaborator
- Public Health Englandcollaborator
Study Sites (12)
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
Related Publications (1)
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.
PMID: 25684279RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul J Turner, FRACP PhD
Imperial College London
- PRINCIPAL INVESTIGATOR
Mich Erlewyn-Lajeunesse, DM FRCPCH
University Hospitals Southampton NHS Foundation Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MRC Clinician Scientist in Paediatric Allergy & Immunology
Study Record Dates
First Submitted
May 17, 2013
First Posted
May 21, 2013
Study Start
September 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
August 10, 2020
Record last verified: 2020-08