Safety of Nasal Influenza Immunisation in Egg Allergic Children (SNIFFLE)

August 6, 2020 updated by: Paul Turner, University Hospital Southampton NHS Foundation Trust

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

282

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom
        • Sandwell General Hospital
      • Bristol, United Kingdom
        • Bristol Royal Hospital for Children
      • Edinburgh, United Kingdom
        • Royal Hospital for Sick Children
      • Leicester, United Kingdom
        • Leicester Royal Infirmary
      • Liverpool, United Kingdom
        • Alder Hey Children's Hospital
      • London, United Kingdom
        • Evelina Children's Hospital
      • London, United Kingdom
        • Imperial College Healthcare NHS Trust (St. Mary's Hospital)
      • London, United Kingdom
        • London St George's Hospital
      • Manchester, United Kingdom
        • Manchester Royal Children's
      • Newcastle, United Kingdom
        • Newcastle Freeman Hospital
      • Oxford, United Kingdom
        • Oxford
      • Southampton, United Kingdom
        • University Hospitals Southampton NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and young people with egg allergy between 2-17 years old

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Egg allergic children
Administration of Live attenuated influenza vaccine
Biological: Administration of Live attenuated influenza vaccine
Other Names:
  • Fluenz (EMA approval number EU/1/10/661/002)
  • FluMist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Within 2 hours of vaccine administration

Secondary Outcome Measures

Outcome Measure
Time Frame
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
72 hours after vaccine administration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of immediate allergic reaction to LAIV in the subgroups described below.
Time Frame: Within 2 hours of vaccine administration
  1. By age group 2-5, 5-11, 12-17 years
  2. children with a previous history of anaphylaxis to egg protein,
  3. children who have reacted previously to airborne traces of egg,
  4. children who have egg allergy but are tolerant of baked egg,
  5. Presence of physician-diagnosed asthma / recurrent wheeze
  6. Presence of active allergic rhinitis to common environmental indoor allergens
Within 2 hours of vaccine administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Southampton NHS Foundation Trust

Collaborators

Imperial College London
Public Health England

Investigators

  • Principal Investigator: Paul J Turner, FRACP PhD, Imperial College London
  • Principal Investigator: Mich Erlewyn-Lajeunesse, DM FRCPCH, University Hospitals Southampton NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

May 17, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (Estimate)

May 21, 2013

Study Record Updates

Last Update Posted (Actual)

August 10, 2020

Last Update Submitted That Met QC Criteria

August 6, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHM CHI 0659

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Egg Hypersensitivity

Clinical Trials on Administration of Live attenuated influenza vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe