Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 Study
- Conditions
- Egg Hypersensitivity
- Interventions
- Drug: Administration of Live attenuated influenza vaccine (LAIV)
- Registration Number
- NCT02111512
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 779
- Aged 2 - 17 years old
- Physician-diagnosis of egg allergy
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Egg allergic children Administration of Live attenuated influenza vaccine (LAIV) Children with a physician diagnosis of egg allergy will be recruited to receive the intranasal LAIV as part of a safety surveillance study
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Asthma control test 4 weeks post LAIV To assess for a change in asthma control (by validated questionnaire) pre and 4 weeks post LAIV immunisation.
Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children 72 hours after vaccine administration
Trial Locations
- Locations (29)
Kings College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Wye Valley NHS Trust
🇬🇧Hereford, United Kingdom
Sandwell General Hospital
🇬🇧Birmingham, United Kingdom
Bristol Royal Hospital for Children
🇬🇧Bristol, United Kingdom
Ulster Hospital
🇬🇧Belfast, Northern Ireland, United Kingdom
Royal United Hospital Bath NHS Trust
🇬🇧Bath, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Alder Hey Children's Hospital
🇬🇧Liverpool, United Kingdom
London St George's Hospital
🇬🇧London, United Kingdom
Cambridgeshire Community Services NHS Trust (Hinchingbrooke Hospital)
🇬🇧Huntingdon, United Kingdom
Barts Health NHS Trust
🇬🇧London, United Kingdom
Manchester Royal Children's
🇬🇧Manchester, United Kingdom
Royal Hospital for Sick Children
🇬🇧Edinburgh, United Kingdom
Evelina Children's Hospital
🇬🇧London, United Kingdom
Imperial College Healthcare NHS Trust (St. Mary's Hospital)
🇬🇧London, United Kingdom
University College London Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
Luton and Dunstable Hospital
🇬🇧Luton, United Kingdom
Oxford
🇬🇧Oxford, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
🇬🇧Preston, United Kingdom
Newcastle Freeman Hospital
🇬🇧Newcastle, 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
Leeds Children's Hospital
🇬🇧Leeds, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
James Paget University Hospitals NHS Foundation Trust
🇬🇧Great Yarmouth, United Kingdom
Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom