MedTrace Logo

Safety of Nasal Influenza Immunisation in Egg Allergic Children

NCT01859039 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 282

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 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.

Conditions

  • Egg Hypersensitivity

Interventions

BIOLOGICAL

Administration of Live attenuated influenza vaccine

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • Public Health England

    collaborator OTHER_GOV

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Paul J Turner, FRACP PhD · Imperial College London

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

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT01859039 on ClinicalTrials.gov