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

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2013-002031-26-GB
• Date of registration: 30/05/2013
• Prospective Registration: Yes
• Primary sponsor: University Hospitals Southampton NHS Foundation Trust
• Public title: Is a new influenza vaccine (given by nasal spray) safe for use in egg-allergic children?
• Scientific title: Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE study - SNIFFLE Study
• Date of first enrolment: 25/06/2013
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002031-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

United Kingdom

Contacts

• Name: Dr Paul Turner
• Affiliation: Imperial College London

• Name: Dr Paul Turner
• Affiliation: Imperial College London

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Children aged 24 months to (and including) 17 years with IgE-mediated food allergy to egg protein
MedDRA version: 16.0 Level: LLT Classification code 10014315 Term: Egg allergy System Organ Class: 100000004870

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Trade Name: Fluenz nasal spray suspension Influenza vaccine
Product Name: Fluenz
Pharmaceutical Form: Nasal spray, suspension
INN or Proposed INN: Reassortant influenza virus (live attenuated)
Concentration unit: Other
Concentration type: equal
Concentration number: as above-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Subjects will be observed for at least 60 minutes following administration of the vaccine.

Primary end point(s): Immediate allergic reaction to Fluenz intranasal vaccination (onset of symptoms within 2 hours following administration) as defined by international criteria (PRACTALL consensus criteria), as per Sampson et al J Allergy Clin Immunol. 2012 130(6):1260-74.

Secondary Objective: Is the administration of the intranasal LAIV influenza ('flu) vaccine safe in children who have experienced a previous severe allergic reaction (anaphylaxis) to egg?

Main Objective: Is the administration of the intranasal LAIV influenza ('flu) vaccine safe in children with egg allergy?

Secondary Outcome(s)

Secondary end point(s): 1. Delayed onset allergic reaction (within 72 hours following administration)
2. Adverse events (of non-allergic aetiology) following administration
3. Nasal obstruction (change in nasal patency as determined by acoustic rhinometry) following vaccine administration (in a subgroup of participants)

Timepoint(s) of evaluation of this end point: Delayed events will be assessed by telephone follow-up within 4-7 days of vaccination.
Nasal obstruction will be determined at 0, 10 and 30 minutes after administration of vaccine.

Secondary ID(s)

RHMCHI065

Source(s) of Monetary Support

Public Health England (Department of Health Research and Development Directorate)