Completed

NCT Number: NCT02111512

Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 Study

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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Key information

Conditions

Egg Hypersensitivity Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ulster Hospital, Belfast, Northern Ireland, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged 2 - 17 years old
Physician-diagnosis of egg allergy

Exclusion criteria

Clinical resolution of egg allergy
Contraindications to LAIV (notwithstanding allergy to egg protein):

Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)
Previous systemic allergic reaction to LAIV
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
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.
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.
Contraindication to vaccination on that occasion, due to child being acutely unwell:

Febrile ≥38.0oC in last 72 hours
Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child's treating healthcare professional
Recent admission to hospital in last 2 weeks for acute asthma
Current oral steroid for asthma exacerbation or course completed within last 2 weeks

Treatment and study plan

Administration of Live attenuated influenza vaccine (LAIV)

Drug

Primary outcomes

Incidence of allergic reaction to nasal influenza vaccination using a Live Attenuated Influenza Vaccine (LAIV) in egg-allergic children

Time frame: Within 2 hours of vaccine administration

Secondary outcomes

Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children

Time frame: 72 hours after vaccine administration
Asthma control test

Time frame: 4 weeks post LAIV

To assess for a change in asthma control (by validated questionnaire) pre and 4 weeks post LAIV immunisation.

Other outcomes

Incidence of immediate allergic reaction to LAIV in the subgroups described below.

Time frame: Within 2 hours of vaccine administration
- By age group 2-5, 6-11, 12-17 years
- Children with a clinician-assessed history of reaction to egg in the previous 12 months
- Children with evidence of >95% likelihood of egg allergy (as per published criteria) within the past 3 months
- Children with evidence of >95% likelihood of egg allergy (as per published criteria) within the past 12 months
- children with a previous history of anaphylaxis to egg protein
- children who have reacted previously to airborne traces of egg
- children who have egg allergy but are tolerant of baked egg
- Children who have previously received influenza vaccine
- Presence of physician-diagnosed asthma / recurrent wheeze

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Collaborators

Imperial College London
Public Health England

Registry information

Official study title

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

Acronym: SNIFFLE-2

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Apr 11, 2014
Registry last updated: Aug 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed