Is a new influenza vaccine (given by nasal spray) safe for use in egg-allergic children?

Phase 1

• Conditions: Children aged 24 months to (and including) 17 years with IgE-mediated food allergy to egg protein; MedDRA version: 16.0Level: LLTClassification code 10014315Term: Egg allergySystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-002031-26-GB
• Lead Sponsor: niversity Hospitals Southampton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-30
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Aged 2 – 17 years old inclusive

2. Physician-diagnosis of egg allergy on the basis of:
a. Positive oral food challenge to egg (conducted under medical supervision) within the last 6 months; OR
b. History of convincing clinical reaction AND positive skin prick test to ovalbumin at visit 1; OR
c. Evidence of >95% likelihood of egg allergy (on the basis of serum specific IgE or skin prick test (SPT) to ovalbumin within past 12 months) (15) but with no prior history of exposure to egg AND positive skin prick test to ovalbumin at visit 1

3. Written informed consent from parent/guardian +/- assent from the child.
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
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. Contraindicated as acutely unwell or current unstable asthma
a. Acute wheeze in last 72 hours requiring treatment
b. Febrile =38.0oC in last 72 hours
c. Recent admission to hospital in last 2 weeks for acute asthma

2. Current medication
a. Use of asthma reliever medication in last 72 hours
b. Recent administration of a medication containing antihistamine within the last 4 days
c. Current oral steroid for asthma exacerbation or course completed within last 2 weeks

3. Contraindications to LAIV (notwithstanding allergy to egg protein):
a. Hypersensitivity to the active ingredients, to gelatin or to gentamicin (a possible trace residue)
b. Previous allergic reaction to an influenza vaccine

4. 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. NB: LAIV (FluEnz) 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.

5. 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.

Study & Design

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