Sponsor study identifier
Secondary identifiers
interventional
779
1 country
29
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2015
Actual (reported)Study Completion
March 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 4, 2014
Actual (reported)April 11, 2014
Actual (reported)September 2014
Date type not reportedThis date has not been verified as actual or estimated.
February 2015
Actual (reported)March 2015
Actual (reported)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
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
Incidence of immediate allergic reaction to LAIV in the subgroups described below.
Within 2 hours of vaccine administration
Children with a physician diagnosis of egg allergy will be recruited to receive the intranasal LAIV as part of a safety surveillance study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
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.
Mich Erlewyn-Lajeunesse, DM FRCPCH
University Hospitals Southampton NHS Foundation Trust
Paul J Turner, FRACP PhD
Imperial College London
779 participants (actual enrollment reported by the registry).
First Submitted
April 4, 2014
First Posted
April 11, 2014
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Egg Oral Immunotherapy
Contact the study team to confirm eligibility.
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
Primary Completion
February 2015
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
August 10, 2020
Record last verified: 2020-08
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Source: ClinicalTrials.gov.
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