Clinical trial NCT01859039: Safety of Nasal Influenza Immunisation in Egg Allergic Children
Official title: Phase 4 Study to Assess the Safety of Nasal Influenza Immunisation in Egg Allergic Children - a Multicentre Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Egg Hypersensitivity
Keywords: Egg allergy
Anaphylaxis
Children
Influenza vaccine
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Imperial College London
name: Public Health England
First posted: 2013-05-21
Enrollment: 282
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and young people with egg allergy between 2-17 years old

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.


Eligibility criteria: Inclusion Criteria:

* Aged 2 - 17 years old
* Physician-diagnosis of egg allergy

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of allergic reaction to nasal influenza vaccination using a Live Attenuated Influenza Vaccine (LAIV) in egg-allergic children
timeFrame: Within 2 hours of vaccine administration
Secondary outcomes:
measure: Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children
timeFrame: 72 hours after vaccine administration
Other outcomes:
measure: Incidence of immediate allergic reaction to LAIV in the subgroups described below.
timeFrame: Within 2 hours of vaccine administration
Locations:
city: Birmingham
country: United Kingdom
facility: Sandwell General Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
city: London
country: United Kingdom
facility: Evelina Children's Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust (St. Mary's Hospital)
city: London
country: United Kingdom
facility: London St George's Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Children's
city: Newcastle
country: United Kingdom
facility: Newcastle Freeman Hospital
city: Oxford
country: United Kingdom
facility: Oxford
city: Southampton
country: United Kingdom
facility: University Hospitals Southampton NHS Foundation Trust
Study officials:
affiliation: Imperial College London
name: Paul J Turner, FRACP PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Southampton NHS Foundation Trust
name: Mich Erlewyn-Lajeunesse, DM FRCPCH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.