Is a nasal spray flu vaccine safe for use in egg-allergic children?

• Conditions: Children aged 24 months to (and including) 17 years with IgE-mediated food allergy to egg protein; MedDRA version: 17.0Level: LLTClassification code 10014315Term: Egg allergySystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-001537-92-GB
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-13
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 730

Inclusion Criteria

1.Aged 2 – 17 years old

2.Physician-diagnosis of egg allergy WITH current avoidance of egg in one of the following categories:
•E0 – avoids all foods containing egg in any form
•E1 – tolerates egg in baked foods (cakes, biscuits) but not other forms
•E2 – able to eat lightly cooked egg (e.g. scrambled egg, boiled egg) but reacts to raw egg in uncooked cake mixtures, fresh mayonnaise, ice cream etc.

3.Written informed consent from parent/guardian (or the patient themselves from age 16 years), with assent from children aged 8 years and above wherever possible.

Are the trial subjects under 18? yes
Number of subjects for this age range: 730
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Clinical resolution of egg allergy

2.Contraindications to LAIV (notwithstanding allergy to egg protein):
a.Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)
b.Previous systemic allergic reaction to LAIV
c.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
d.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.
e.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:
a.Febrile =38.0oC in last 72 hours
b.Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child’s treating healthcare professional
c.Recent admission to hospital in last 2 weeks for acute asthma
d.Current oral steroid for asthma exacerbation or course completed within last 2 weeks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified