Status:

COMPLETED

Safety of Nasal Influenza Immunisation in Egg Allergic Children

Lead Sponsor:

University Hospital Southampton NHS Foundation Trust

Collaborating Sponsors:

Imperial College London

Public Health England

Conditions:

Egg Hypersensitivity

Eligibility:

All Genders

2-17 years

Brief 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 da...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

September 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 1 2014

Estimated Enrollment :

282 Patients enrolled

Trial Details

Trial ID

NCT01859039

Start Date

September 1 2013

End Date

February 1 2014

Last Update

August 10 2020

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Sandwell General Hospital

Birmingham, United Kingdom

2

Bristol Royal Hospital for Children

Bristol, United Kingdom

3

Royal Hospital for Sick Children

Edinburgh, United Kingdom

4

Leicester Royal Infirmary

Leicester, United Kingdom