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

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ClinicalTrials.gov Identifier: NCT02111512
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : May 28, 2015
Sponsor:
Collaborators:
University Hospital Southampton NHS Foundation Trust
Public Health England
Information provided by (Responsible Party):
Paul Turner, Imperial College London

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.


Condition or disease Intervention/treatment Phase
Egg Hypersensitivity Drug: Administration of Live attenuated influenza vaccine (LAIV) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 779 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 4 Study to Assess the Safety of Nasal Influenza Immunisation in Egg Allergic Children - a Multicentre Observational Study
Study Start Date : September 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Flu Flu Shot

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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.


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111512


Locations
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United Kingdom
Ulster Hospital
Belfast, Northern Ireland, United Kingdom
Royal United Hospital Bath NHS Trust
Bath, 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
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
James Paget University Hospitals NHS Foundation Trust
Norfolk, 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, United Kingdom
Sponsors and Collaborators
Imperial College London
University Hospital Southampton NHS Foundation Trust
Public Health England
Investigators
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Principal Investigator: Mich Erlewyn-Lajeunesse, DM FRCPCH University Hospitals Southampton NHS Foundation Trust
Principal Investigator: Paul J Turner, FRACP PhD Imperial College London

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paul Turner, MRC Clinician Scientist, Imperial College London
ClinicalTrials.gov Identifier: NCT02111512     History of Changes
Other Study ID Numbers: RHM CHI 0714
2014-001537-92 ( EudraCT Number )
17189 ( Registry Identifier: UKCRN )
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Hypersensitivity
Egg Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Vaccines
Immunologic Factors
Physiological Effects of Drugs