Egg HypersensitivitySNIFFLENCT01859039
Safety of Nasal Influenza Immunisation in Egg Allergic Children
An observational study of Egg Hypersensitivity, run by University Hospital Southampton NHS Foundation Trust at 12 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Egg Hypersensitivity
- What is being tested?
- Administration of Live attenuated influenza vaccine
- Type of treatment
- Vaccines
- How many people
- 282 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- Sep 2013to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and young people with egg allergy between 2-17 years old
Who may be able to join
- Aged 2 - 17 years old
- Physician-diagnosis of egg allergy
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites
Sandwell General Hospital
Birmingham
Bristol Royal Hospital for Children
Bristol
Royal Hospital for Sick Children
Edinburgh
Leicester Royal Infirmary
Leicester
Alder Hey Children's Hospital
Liverpool
Evelina Children's Hospital
London
Imperial College Healthcare NHS Trust (St. Mary's Hospital)
London
London St George's Hospital
London
Manchester Royal Children's
Manchester
Newcastle Freeman Hospital
Newcastle
Oxford
Oxford
University Hospitals Southampton NHS Foundation Trust
Southampton
About this study
Official title: Phase 4 Study to Assess the Safety of Nasal Influenza Immunisation in Egg Allergic Children - a Multicentre Observational Study
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
- Being tested
- Administration of Live attenuated influenza vaccine
- Keywords
- Egg allergy, Anaphylaxis, Children, Influenza vaccine
- Medical subject headings
- Egg Hypersensitivity, Anaphylaxis, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of Live attenuated influenza vaccineBiological
Also called Fluenz (EMA approval number EU/1/10/661/002), FluMist
| Study group | Role | What they receive |
|---|---|---|
| Egg allergic children | Administration of Live attenuated influenza vaccine Receives: Biological: Administration of Live attenuated influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of allergic reaction to nasal influenza vaccination using a Live Attenuated Influenza Vaccine (LAIV) in egg-allergic children
Measured: Within 2 hours of vaccine administration
Secondary outcomes (1)
Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children
Measured: 72 hours after vaccine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Egg HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, Public Health England
- Responsible party
- Principal investigator, Paul Turner, Imperial College London
- Investigators
- Paul J Turner, FRACP PhD, Principal investigator, Imperial College LondonMich Erlewyn-Lajeunesse, DM FRCPCH, Principal investigator, University Hospitals Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859039
- Sponsor's protocol ID
- RHM CHI 0659
- Acronym
- SNIFFLE
- Status last verified
- Aug 2020
- First submitted
- 17 May 2013
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Turner PJ, Southern J, Andrews NJ, Miller E, Erlewyn-Lajeunesse M; SNIFFLE Study Investigators. Safety of live attenuated influenza vaccine in atopic children with egg allergy. J Allergy Clin Immunol. 2015 Aug;136(2):376-81. doi: 10.1016/j.jaci.2014.12.1925. Epub 2015 Feb 13.
PubMed 25684279
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study to Assess the Safety of Nasal Influenza Immunisation in Egg Allergic Children - a Multicentre Observational Study
- ClinicalTrials.gov ID
- NCT01859039
- Acronym / sponsor ID
- SNIFFLE / RHM CHI 0659
- Conditions
- Egg Hypersensitivity
- Keywords
- Egg allergy, Anaphylaxis, Children, Influenza vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College London, Public Health England
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Egg allergic children | – | Biological: Administration of Live attenuated influenza vaccineAdministration of Live attenuated influenza vaccine |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and young people with egg allergy between 2-17 years old
Key inclusion criteria (2 listed)
- Aged 2 - 17 years old
- Physician-diagnosis of egg allergy
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of Live attenuated influenza vaccineAlso: Fluenz (EMA approval number EU/1/10/661/002), FluMist | Biological | Egg allergic children |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Results publication: PubMed 25684279Turner PJ, Southern J, Andrews NJ, Miller E, Erlewyn-Lajeunesse M; SNIFFLE Study Investigators. Safety of live attenuated influenza vaccine in atopic children with egg allergy. J Allergy Clin Immunol. 2015 Aug;136(2):376-81. doi: 10.1016/j.jaci.2014.12.1925. Epub 2015 Feb 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J Turner, FRACP PhD principal investigator
Imperial College London
Mich Erlewyn-Lajeunesse, DM FRCPCH principal investigator
University Hospitals Southampton NHS Foundation Trust
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Egg Hypersensitivity, run by University Hospital Southampton NHS Foundation Trust at 12 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020.