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

Primary Purpose

Egg Hypersensitivity

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Administration of Live attenuated influenza vaccine (LAIV)
Sponsored by
University Hospital Southampton NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Egg Hypersensitivity

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ulster Hospital
  • Royal United Hospital Bath NHS Trust
  • Sandwell General Hospital
  • Bristol Royal Hospital for Children
  • Cambridge University Hospitals NHS Foundation Trust
  • Royal Hospital for Sick Children
  • James Paget University Hospitals NHS Foundation Trust
  • Wye Valley NHS Trust
  • Cambridgeshire Community Services NHS Trust (Hinchingbrooke Hospital)
  • Leeds Children's Hospital
  • Leicester Royal Infirmary
  • Alder Hey Children's Hospital
  • Barts Health NHS Trust
  • Evelina Children's Hospital
  • Imperial College Healthcare NHS Trust (St. Mary's Hospital)
  • Kings College Hospital NHS Foundation Trust
  • London St George's Hospital
  • Royal Free London NHS Foundation Trust
  • University College London Hospitals NHS Foundation Trust
  • Luton and Dunstable Hospital
  • Manchester Royal Children's
  • Newcastle Freeman Hospital
  • Oxford
  • Lancashire Teaching Hospitals NHS Foundation Trust
  • Sheffield Children's Hospital NHS Foundation Trust
  • Shrewsbury and Telford Hospital NHS Trust
  • University Hospitals Southampton NHS Foundation Trust
  • Warrington & Halton Hospitals NHS Foundation Trust
  • Hampshire Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Egg allergic children

Arm Description

Children with a physician diagnosis of egg allergy will be recruited to receive the intranasal LAIV as part of a safety surveillance study

Outcomes

Primary Outcome Measures

Incidence of allergic reaction to nasal influenza vaccination using a Live Attenuated Influenza Vaccine (LAIV) in egg-allergic children

Secondary Outcome Measures

Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children
Asthma control test
To assess for a change in asthma control (by validated questionnaire) pre and 4 weeks post LAIV immunisation.

Full Information

First Posted
April 4, 2014
Last Updated
August 6, 2020
Sponsor
University Hospital Southampton NHS Foundation Trust
Collaborators
Imperial College London, Public Health England
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1. Study Identification

Unique Protocol Identification Number
NCT02111512
Brief Title
Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 Study
Acronym
SNIFFLE-2
Official Title
Phase 4 Study to Assess the Safety of Nasal Influenza Immunisation in Egg Allergic Children - a Multicentre Observational Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Southampton NHS Foundation Trust
Collaborators
Imperial College London, Public Health England

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Egg Hypersensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
779 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Egg allergic children
Arm Type
Other
Arm Description
Children with a physician diagnosis of egg allergy will be recruited to receive the intranasal LAIV as part of a safety surveillance study
Intervention Type
Drug
Intervention Name(s)
Administration of Live attenuated influenza vaccine (LAIV)
Primary Outcome Measure Information:
Title
Incidence of allergic reaction to nasal influenza vaccination using a Live Attenuated Influenza Vaccine (LAIV) in egg-allergic children
Time Frame
Within 2 hours of vaccine administration
Secondary Outcome Measure Information:
Title
Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children
Time Frame
72 hours after vaccine administration
Title
Asthma control test
Description
To assess for a change in asthma control (by validated questionnaire) pre and 4 weeks post LAIV immunisation.
Time Frame
4 weeks post LAIV
Other Pre-specified Outcome Measures:
Title
Incidence of immediate allergic reaction to LAIV in the subgroups described below.
Description
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
Time Frame
Within 2 hours of vaccine administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 2 - 17 years old Physician-diagnosis of egg allergy Exclusion Criteria: Clinical resolution of egg allergy 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mich Erlewyn-Lajeunesse, DM FRCPCH
Organizational Affiliation
University Hospitals Southampton NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul J Turner, FRACP PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulster Hospital
City
Belfast
State/Province
Northern Ireland
Country
United Kingdom
Facility Name
Royal United Hospital Bath NHS Trust
City
Bath
Country
United Kingdom
Facility Name
Sandwell General Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Bristol Royal Hospital for Children
City
Bristol
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
Country
United Kingdom
Facility Name
James Paget University Hospitals NHS Foundation Trust
City
Great Yarmouth
Country
United Kingdom
Facility Name
Wye Valley NHS Trust
City
Hereford
Country
United Kingdom
Facility Name
Cambridgeshire Community Services NHS Trust (Hinchingbrooke Hospital)
City
Huntingdon
Country
United Kingdom
Facility Name
Leeds Children's Hospital
City
Leeds
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
Country
United Kingdom
Facility Name
Alder Hey Children's Hospital
City
Liverpool
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
London
Country
United Kingdom
Facility Name
Evelina Children's Hospital
City
London
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust (St. Mary's Hospital)
City
London
Country
United Kingdom
Facility Name
Kings College Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
London St George's Hospital
City
London
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Luton and Dunstable Hospital
City
Luton
Country
United Kingdom
Facility Name
Manchester Royal Children's
City
Manchester
Country
United Kingdom
Facility Name
Newcastle Freeman Hospital
City
Newcastle
Country
United Kingdom
Facility Name
Oxford
City
Oxford
Country
United Kingdom
Facility Name
Lancashire Teaching Hospitals NHS Foundation Trust
City
Preston
Country
United Kingdom
Facility Name
Sheffield Children's Hospital NHS Foundation Trust
City
Sheffield
Country
United Kingdom
Facility Name
Shrewsbury and Telford Hospital NHS Trust
City
Shrewsbury
Country
United Kingdom
Facility Name
University Hospitals Southampton NHS Foundation Trust
City
Southampton
Country
United Kingdom
Facility Name
Warrington & Halton Hospitals NHS Foundation Trust
City
Warrington
Country
United Kingdom
Facility Name
Hampshire Hospital NHS Foundation Trust
City
Winchester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26645895
Citation
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.
Results Reference
result

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

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