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

NCT02111512 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 779

Last updated 2020-08-10

No results posted yet for this study

Summary

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.

Conditions

  • Egg Hypersensitivity

Interventions

DRUG

Administration of Live attenuated influenza vaccine (LAIV)

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • Public Health England

    collaborator OTHER_GOV

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Mich Erlewyn-Lajeunesse, DM FRCPCH · University Hospitals Southampton NHS Foundation Trust

  • Paul J Turner, FRACP PhD · Imperial College London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-02-28
Completion
2015-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02111512 on ClinicalTrials.gov