Egg HypersensitivityPhase 4SNIFFLE-2NCT02111512
Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 Study
A Phase 4 study testing Administration of Live attenuated influenza vaccine (LAIV) in people with Egg Hypersensitivity, run by University Hospital Southampton NHS Foundation Trust at 29 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 (LAIV)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 779 participants
- Where
- 29 sitesUnited Kingdom
- Study dates
- Sep 2014to Mar 2015
- Phase
- Phase 4
- 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
Who may be able to join
- Aged 2 - 17 years old
- Physician-diagnosis of egg allergy
Who cannot join
- Clinical resolution of egg allergy
- Contraindications to LAIV (notwithstanding allergy to egg protein):
- Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)
- Previous systemic allergic reaction to LAIV
- Previous allergic reaction to an influenza vaccine (not LAIV) is a relative contra-indication, which must be discussed with the site PI to confirm patient suitability
- Children/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. NB: LAIV is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.
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- 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.
- Contraindication to vaccination on that occasion, due to child being acutely unwell:
- Febrile ≥38.0oC in last 72 hours
- Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child's treating healthcare professional
- Recent admission to hospital in last 2 weeks for acute asthma
- Current oral steroid for asthma exacerbation or course completed within last 2 weeks
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United Kingdom29 sites
Royal United Hospital Bath NHS Trust
Bath
Ulster Hospital
Belfast, Northern Ireland
Sandwell General Hospital
Birmingham
Bristol Royal Hospital for Children
Bristol
Cambridge University Hospitals NHS Foundation Trust
Cambridge
Royal Hospital for Sick Children
Edinburgh
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth
Wye Valley NHS Trust
Hereford
Cambridgeshire Community Services NHS Trust (Hinchingbrooke Hospital)
Huntingdon
Leeds Children's Hospital
Leeds
Leicester Royal Infirmary
Leicester
Alder Hey Children's Hospital
Liverpool
Barts Health NHS Trust
London
Evelina Children's Hospital
London
Imperial College Healthcare NHS Trust (St. Mary's Hospital)
London
Kings College Hospital NHS Foundation Trust
London
London St George's Hospital
London
Royal Free London NHS Foundation Trust
London
University College London Hospitals NHS Foundation Trust
London
Luton and Dunstable Hospital
Luton
Manchester Royal Children's
Manchester
Newcastle Freeman Hospital
Newcastle
Oxford
Oxford
Lancashire Teaching Hospitals NHS Foundation Trust
Preston
Sheffield Children's Hospital NHS Foundation Trust
Sheffield
Shrewsbury and Telford Hospital NHS Trust
Shrewsbury
University Hospitals Southampton NHS Foundation Trust
Southampton
Warrington & Halton Hospitals NHS Foundation Trust
Warrington
Hampshire Hospital NHS Foundation Trust
Winchester
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 published data on the safety of LAIV in egg-allergic children. In SNIFFLE 1 Study, 433 doses were given to 282 egg-allergic children; data is currently being analysed.
The objective of this multicentre study is to further 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 (LAIV)
- Medical subject headings
- Egg Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of Live attenuated influenza vaccine (LAIV)Drug
| Study group | Role | What they receive |
|---|---|---|
| Egg allergic children | Other | Children with a physician diagnosis of egg allergy will be recruited to receive the intranasal LAIV as part of a safety surveillance study Receives: Drug: Administration of Live attenuated influenza vaccine (LAIV) |
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 (2)
Incidence of delayed symptoms up to 72 hours after nasal influenza vaccination with LAIV in egg-allergic children
Measured: 72 hours after vaccine administration
Asthma control test
To assess for a change in asthma control (by validated questionnaire) pre and 4 weeks post LAIV immunisation.
Measured: 4 weeks post LAIV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionMar 2015
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 779 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
- Mich Erlewyn-Lajeunesse, DM FRCPCH, Principal investigator, University Hospitals Southampton NHS Foundation TrustPaul J Turner, FRACP PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111512
- Sponsor's protocol ID
- RHM CHI 0714
- Other IDs
- 2014-001537-92, 17189, 2014
- Acronym
- SNIFFLE-2
- Status last verified
- Aug 2020
- First submitted
- 4 Apr 2014
- 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-2 Study Investigators. Safety of live attenuated influenza vaccine in young people with egg allergy: multicentre prospective cohort study. BMJ. 2015 Dec 8;351:h6291. doi: 10.1136/bmj.h6291.
PubMed 26645895
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
- NCT02111512
- Acronym / sponsor ID
- SNIFFLE-2 / RHM CHI 0714
- Conditions
- Egg Hypersensitivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 779 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College London, Public Health England
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Apr 2014 (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 published data on the safety of LAIV in egg-allergic children. In SNIFFLE 1 Study, 433 doses were given to 282 egg-allergic children; data is currently being analysed.
The objective of this multicentre study is to further 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Egg allergic children | Other | Drug: Administration of Live attenuated influenza vaccine (LAIV)Children with a physician diagnosis of egg allergy will be recruited to receive the intranasal LAIV as part of a safety surveillance study |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aged 2 - 17 years old
- Physician-diagnosis of egg allergy
Key exclusion criteria (12 listed)
- Clinical resolution of egg allergy
- Contraindications to LAIV (notwithstanding allergy to egg protein):
- Contraindication to vaccination on that occasion, due to child being acutely unwell:
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 vaccine (LAIV) | Drug | 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
2 secondary outcomes
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
Asthma control test
Time frame: 4 weeks post LAIV
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 26645895Turner PJ, Southern J, Andrews NJ, Miller E, Erlewyn-Lajeunesse M; SNIFFLE-2 Study Investigators. Safety of live attenuated influenza vaccine in young people with egg allergy: multicentre prospective cohort study. BMJ. 2015 Dec 8;351:h6291. doi: 10.1136/bmj.h6291.
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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.
Mich Erlewyn-Lajeunesse, DM FRCPCH principal investigator
University Hospitals Southampton NHS Foundation Trust
Paul J Turner, FRACP PhD principal investigator
Imperial College London
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Administration of Live attenuated influenza vaccine (LAIV) in people with Egg Hypersensitivity, run by University Hospital Southampton NHS Foundation Trust at 29 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 12 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 29 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 NCT02111512, 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; AzTrials last refreshed its copy on 8 Nov 2026.