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

This study has been completed.
Sponsor:
Collaborators:
University Hospitals Southampton NHS Foundation Trust (SPONSOR)
Public Health England (formerly Health Protection Agency)
Information provided by (Responsible Party):
Paul Turner, Imperial College London
ClinicalTrials.gov Identifier:
NCT01859039
First received: May 17, 2013
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Egg Hypersensitivity
Biological: Administration of Live attenuated influenza vaccine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 4 Study to Assess the Safety of Nasal Influenza Immunisation in Egg Allergic Children - a Multicentre Observational Study

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Incidence of immediate allergic reaction to LAIV in the subgroups described below. [ Time Frame: Within 2 hours of vaccine administration ] [ Designated as safety issue: Yes ]
    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


Enrollment: 282
Study Start Date: September 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01859039

Locations
United Kingdom
Sandwell General Hospital
Birmingham, United Kingdom
Bristol Royal Hospital for Children
Bristol, United Kingdom
Royal Hospital for Sick Children
Edinburgh, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Alder Hey Children's Hospital
Liverpool, United Kingdom
London St George's Hospital
London, United Kingdom
Evelina Children's Hospital
London, United Kingdom
Imperial College Healthcare NHS Trust (St. Mary's Hospital)
London, United Kingdom
Manchester Royal Children's
Manchester, United Kingdom
Newcastle Freeman Hospital
Newcastle, United Kingdom
Oxford
Oxford, United Kingdom
University Hospitals Southampton NHS Foundation Trust
Southampton, United Kingdom
Sponsors and Collaborators
Imperial College London
University Hospitals Southampton NHS Foundation Trust (SPONSOR)
Public Health England (formerly Health Protection Agency)
Investigators
Principal Investigator: Paul J Turner, FRACP PhD Imperial College London
Principal Investigator: Mich Erlewyn-Lajeunesse, DM FRCPCH University Hospitals Southampton NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Paul Turner, MRC Clinician Scientist in Paediatric Allergy & Immunology, Imperial College London
ClinicalTrials.gov Identifier: NCT01859039     History of Changes
Other Study ID Numbers: RHM CHI 0659
Study First Received: May 17, 2013
Last Updated: April 4, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
Egg allergy
Anaphylaxis
Children
Influenza vaccine

Additional relevant MeSH terms:
Hypersensitivity
Egg Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on September 18, 2014