Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 Study

Egg Hypersensitivity Clinical Trial

— SNIFFLE-2  

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: NCT02111512
• Other study ID #: RHM CHI 0714
• Secondary ID: 2014-001537-9217
• Status: Completed
• Phase: Phase 4
• Start date: September 2014
• Est. completion date: March 2015

Study information

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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 779
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• 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:

1. Clinical resolution of egg allergy

2. Contraindications to LAIV (notwithstanding allergy to egg protein):

• Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)

• Previous systemic allergic reaction to LAIV

• Previous allergic reaction to an influenza vaccine (not LAIV) is a relative contra-indication, which must be discussed with the site PI to confirm patient suitability

• Children/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. NB: LAIV is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.

• 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.

3. Contraindication to vaccination on that occasion, due to child being acutely unwell:

• Febrile =38.0oC in last 72 hours

• Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child's treating healthcare professional

• Recent admission to hospital in last 2 weeks for acute asthma

• Current oral steroid for asthma exacerbation or course completed within last 2 weeks

Related Conditions & MeSH terms

• Egg Hypersensitivity
• Hypersensitivity

Intervention

Drug:
• Administration of Live attenuated influenza vaccine (LAIV)

Locations

Country	Name	City	State
United Kingdom	Royal United Hospital Bath NHS Trust	Bath
United Kingdom	Ulster Hospital	Belfast	Northern Ireland
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	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

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-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/b — 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, 6-11, 12-17 years; Children with a clinician-assessed history of reaction to egg in the previous 12 months; Children with evidence of >95% likelihood of egg allergy (as per published criteria) within the past 3 months; Children with evidence of >95% likelihood of egg allergy (as per published criteria) within the past 12 months; 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; Children who have previously received influenza vaccine; Presence of physician-diagnosed asthma / recurrent wheeze	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
Secondary	Asthma control test	To assess for a change in asthma control (by validated questionnaire) pre and 4 weeks post LAIV immunisation.	4 weeks post LAIV