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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01859039
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : May 28, 2015
University Hospital Southampton NHS Foundation Trust
Public Health England
Information provided by (Responsible Party):
Paul Turner, Imperial College London

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 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 or disease Intervention/treatment
Egg Hypersensitivity Biological: Administration of Live attenuated influenza vaccine

Study Type : Observational
Actual Enrollment : 282 participants
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
Study Start Date : September 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Flu Flu Shot
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and young people with egg allergy between 2-17 years old

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01859039

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
Evelina Children's Hospital
London, United Kingdom
Imperial College Healthcare NHS Trust (St. Mary's Hospital)
London, United Kingdom
London St George's Hospital
London, United Kingdom
Manchester Royal Children's
Manchester, United Kingdom
Newcastle Freeman Hospital
Newcastle, United Kingdom
Oxford, United Kingdom
University Hospitals Southampton NHS Foundation Trust
Southampton, United Kingdom
Sponsors and Collaborators
Imperial College London
University Hospital Southampton NHS Foundation Trust
Public Health England
Principal Investigator: Paul J Turner, FRACP PhD Imperial College London
Principal Investigator: Mich Erlewyn-Lajeunesse, DM FRCPCH University Hospitals Southampton NHS Foundation Trust

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Paul Turner, MRC Clinician Scientist in Paediatric Allergy & Immunology, Imperial College London Identifier: NCT01859039     History of Changes
Other Study ID Numbers: RHM CHI 0659
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Paul Turner, Imperial College London:
Egg allergy
Influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Egg Hypersensitivity
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Immunologic Factors
Physiological Effects of Drugs