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

August 6, 2020 updated by: Paul Turner, University Hospital Southampton NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

779

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bath, United Kingdom
        • Royal United Hospital Bath NHS Trust
      • Birmingham, United Kingdom
        • Sandwell General Hospital
      • Bristol, United Kingdom
        • Bristol Royal Hospital for Children
      • Cambridge, United Kingdom
        • Cambridge University Hospitals NHS Foundation Trust
      • Edinburgh, United Kingdom
        • Royal Hospital for Sick Children
      • Great Yarmouth, United Kingdom
        • James Paget University Hospitals NHS Foundation Trust
      • Hereford, United Kingdom
        • Wye Valley NHS Trust
      • Huntingdon, United Kingdom
        • Cambridgeshire Community Services NHS Trust (Hinchingbrooke Hospital)
      • Leeds, United Kingdom
        • Leeds Children's Hospital
      • Leicester, United Kingdom
        • Leicester Royal Infirmary
      • Liverpool, United Kingdom
        • Alder Hey Children's Hospital
      • London, United Kingdom
        • University College London Hospitals NHS Foundation Trust
      • London, United Kingdom
        • Kings College Hospital NHS Foundation Trust
      • London, United Kingdom
        • Royal Free London NHS Foundation Trust
      • London, 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
        • Barts Health NHS Trust
      • Luton, United Kingdom
        • Luton and Dunstable Hospital
      • Manchester, United Kingdom
        • Manchester Royal Children's
      • Newcastle, United Kingdom
        • Newcastle Freeman Hospital
      • Oxford, United Kingdom
        • Oxford
      • Preston, United Kingdom
        • Lancashire Teaching Hospitals NHS Foundation Trust
      • Sheffield, United Kingdom
        • Sheffield Children's Hospital NHS Foundation Trust
      • Shrewsbury, United Kingdom
        • Shrewsbury and Telford Hospital NHS Trust
      • Southampton, United Kingdom
        • University Hospitals Southampton NHS Foundation Trust
      • Warrington, United Kingdom
        • Warrington & Halton Hospitals NHS Foundation Trust
      • Winchester, United Kingdom
        • Hampshire Hospital NHS Foundation Trust
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom
        • Ulster Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Egg allergic children
Children with a physician diagnosis of egg allergy will be recruited to receive the intranasal LAIV as part of a safety surveillance study
Drug: Administration of Live attenuated influenza vaccine (LAIV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Within 2 hours of vaccine administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
72 hours after vaccine administration
Asthma control test
Time Frame: 4 weeks post LAIV
To assess for a change in asthma control (by validated questionnaire) pre and 4 weeks post LAIV immunisation.
4 weeks post LAIV

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of immediate allergic reaction to LAIV in the subgroups described below.
Time Frame: Within 2 hours of vaccine administration
  1. By age group 2-5, 6-11, 12-17 years
  2. Children with a clinician-assessed history of reaction to egg in the previous 12 months
  3. Children with evidence of >95% likelihood of egg allergy (as per published criteria) within the past 3 months
  4. Children with evidence of >95% likelihood of egg allergy (as per published criteria) within the past 12 months
  5. children with a previous history of anaphylaxis to egg protein
  6. children who have reacted previously to airborne traces of egg
  7. children who have egg allergy but are tolerant of baked egg
  8. Children who have previously received influenza vaccine
  9. Presence of physician-diagnosed asthma / recurrent wheeze
Within 2 hours of vaccine administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Southampton NHS Foundation Trust

Collaborators

Imperial College London
Public Health England

Investigators

  • Principal Investigator: Paul J Turner, FRACP PhD, Imperial College London
  • Principal Investigator: Mich Erlewyn-Lajeunesse, DM FRCPCH, University Hospitals Southampton NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 4, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Actual)

August 10, 2020

Last Update Submitted That Met QC Criteria

August 6, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHM CHI 0714
  • 2014-001537-92 (EudraCT Number)
  • 17189 (Registry Identifier: UKCRN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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