NCT01859039|CompletedDMC
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
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SNIFFLE
Phase 4 Study to Assess the Safety of Nasal Influenza Immunisation in Egg Allergic Children - a Multicentre Observational Study
Sponsor study identifier
observational
282
1 country
12
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Actual (reported)Study Completion
February 2014
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 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2014
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.
May 17, 2013
Actual (reported)May 21, 2013
Actual (reported)September 2013
Date type not reportedThis date has not been verified as actual or estimated.
February 2014
Actual (reported)February 2014
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
Incidence of immediate allergic reaction to LAIV in the subgroups described below.
Within 2 hours of vaccine administration
Administration of Live attenuated influenza vaccine
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Children and young people with egg allergy between 2-17 years old
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
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.
Paul J Turner, FRACP PhD
Imperial College London
Mich Erlewyn-Lajeunesse, DM FRCPCH
University Hospitals Southampton NHS Foundation Trust
282 participants (actual enrollment reported by the registry).
First Submitted
May 17, 2013
First Posted
May 21, 2013
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
Safe Administration of Flu Vaccine to Egg Allergic Children
Contact the study team to confirm eligibility.
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
Primary Completion
February 2014
Actual (reported)Study Completion
February 2014
Actual (reported)Last Updated
August 10, 2020
Record last verified: 2020-08
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Source: ClinicalTrials.gov.
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