Safety of Nasal Influenza Immunisation in Egg Allergic Children

Egg Hypersensitivity Clinical Trial

— SNIFFLE  

Official title:

Phase 4 Study to Assess the Safety of Nasal Influenza Immunisation in Egg Allergic Children - a Multicentre Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859039
• Other study ID #: RHM CHI 0659
• Status: Completed
• Start date: September 2013
• Est. completion date: February 2014

Study information

• Verified date: August 2020
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Egg Hypersensitivity
• Hypersensitivity
• Influenza, Human

Intervention

Biological:
• Administration of Live attenuated influenza vaccine

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust	Imperial College London, Public Health England

Country where clinical trial is conducted

United Kingdom, 

References & 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.2014.12.19 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of immediate allergic reaction to LAIV in the subgroups described below.	By age group 2-5, 5-11, 12-17 years; children with a previous history of anaphylaxis to egg protein,; children who have reacted previously to airborne traces of egg,; children who have egg allergy but are tolerant of baked egg,; Presence of physician-diagnosed asthma / recurrent wheeze; Presence of active allergic rhinitis to common environmental indoor allergens	Within 2 hours of vaccine administration
Primary	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	Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children		72 hours after vaccine administration