Completed

NCT Number: NCT01859039

Safety of Nasal Influenza Immunisation in Egg Allergic Children

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.

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Key information

Conditions

Egg Hypersensitivity Anaphylaxis Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sandwell General Hospital, Birmingham, 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

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.

Treatment and study plan

Administration of Live attenuated influenza vaccine

Biological

Other names: Fluenz (EMA approval number EU/1/10/661/002), FluMist

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

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, 5-11, 12-17 years
- 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,
- Presence of physician-diagnosed asthma / recurrent wheeze
- Presence of active allergic rhinitis to common environmental indoor allergens

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: May 21, 2013
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