A Phase 4 interventional study of Administration of Live attenuated influenza vaccine (LAIV) in Egg Hypersensitivity, sponsored by University Hospital Southampton NHS Foundation Trust. Completed at 29 sites in United Kingdom. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-08-10.
Sponsored by University Hospital Southampton NHS Foundation Trust · Phase 4, Interventional, and Treatment
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.
38 studies on the registry are indexed under Egg Hypersensitivity; 9 are open to participants now.
This study's enrollment of 779 is above the median of 73 across 27 interventional studies indexed under Egg Hypersensitivity.
Browse Egg Hypersensitivity studies →University Hospital Southampton NHS Foundation Trust is the lead sponsor of 150 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
to LAIV (notwithstanding allergy to egg protein):
Contraindication to vaccination on that occasion, due to child being acutely unwell:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children with a physician diagnosis of egg allergy will be recruited to receive the intranasal LAIV as part of a safety surveillance study
Drug: Administration of Live attenuated influenza vaccine (LAIV)
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
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
To assess for a change in asthma control (by validated questionnaire) pre and 4 weeks post LAIV immunisation.
Time frame: 4 weeks post LAIV
Incidence of immediate allergic reaction to LAIV in the subgroups described below.
1. By age group 2-5, 6-11, 12-17 years 2. Children with a clinician-assessed history of reaction to egg in the previous 12 months 3. Children with evidence of \>95% likelihood of egg allergy (as per published criteria) within the past 3 months 4. Children with evidence of \>95% likelihood of egg allergy (as per published criteria) within the past 12 months 5. children with a previous history of anaphylaxis to egg protein 6. children who have reacted previously to airborne traces of egg 7. children who have egg allergy but are tolerant of baked egg 8. Children who have previously received influenza vaccine 9. Presence of physician-diagnosed asthma / recurrent wheeze
Time frame: Within 2 hours of vaccine administration
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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University Hospital Southampton NHS Foundation Trust →