Safety of Nasal Influenza Immunisation in Egg Allergic Children

Study Overview
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Brief Summary
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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 existing data on the safety of LAIV in egg-allergic children. The objective of this multicentre study is to 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.

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

Conditions
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Egg Hypersensitivity

Intervention / Treatment
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* Biological: Administration of Live attenuated influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 2 - 17 years old Physician-diagnosis of egg allergy Exclusion Criteria: Contraindicated as acutely unwell or current unstable asthma Use of asthma reliever medication in last 72 hours Recent administration of a medication containing antihistamine within the last 4 days Current oral steroid for asthma exacerbation or course completed within last 2 weeks Contraindications to ingredient in LAIV (notwithstanding allergy to egg protein) Previous allergic reaction to an influenza vaccine Children and 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. 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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Egg allergic children<br>Administration of Live attenuated influenza vaccine | Biological: Administration of Live attenuated influenza vaccine<br> <br> * Other names: FluMist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

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 |  | 72 hours after vaccine administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Egg allergy, Anaphylaxis, Children, Influenza vaccine