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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001537-92 | EudraCT Number | ||
| 17189 | Registry Identifier | UKCRN |
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| Name | Class |
|---|---|
| Imperial College London | OTHER |
| Public Health England | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Egg allergic children | Other | Children with a physician diagnosis of egg allergy will be recruited to receive the intranasal LAIV as part of a safety surveillance study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of Live attenuated influenza vaccine (LAIV) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children | 72 hours after vaccine administration | |
| Asthma control test | To assess for a change in asthma control (by validated questionnaire) pre and 4 weeks post LAIV immunisation. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of immediate allergic reaction to LAIV in the subgroups described below. |
|
Inclusion Criteria:
Exclusion Criteria:
Clinical resolution of egg allergy
Contraindications to LAIV (notwithstanding allergy to egg protein):
Contraindication to vaccination on that occasion, due to child being acutely unwell:
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| Name | Affiliation | Role |
|---|---|---|
| Mich Erlewyn-Lajeunesse, DM FRCPCH | University Hospitals Southampton NHS Foundation Trust | Principal Investigator |
| Paul J Turner, FRACP PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulster Hospital | Belfast | Northern Ireland | United Kingdom | |||
| Royal United Hospital Bath NHS Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26645895 | Result | 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. |
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| 4 weeks post LAIV |
| Within 2 hours of vaccine administration |
| 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 |
| 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 | United Kingdom |
| ID | Term |
|---|---|
| D021181 | Egg Hypersensitivity |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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