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Clinical Trials/EUCTR2014-001537-92-GB
EUCTR2014-001537-92-GB
Active, not recruiting
Not Applicable

Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 study - SNIFFLE 2 Study

niversity Hospital Southampton NHS Foundation Trust0 sites730 target enrollmentMay 13, 2014
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DrugsFluenz nasal spray suspension Influenza vaccineFluenz Tetra nasal spray suspension Influenza vaccine

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity Hospital Southampton NHS Foundation Trust
Enrollment
730
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 13, 2014
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity Hospital Southampton NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

  • •1\.Aged 2 – 17 years old
  • •2\.Physician\-diagnosis of egg allergy WITH current avoidance of egg in one of the following categories:
  • •E0 – avoids all foods containing egg in any form
  • •E1 – tolerates egg in baked foods (cakes, biscuits) but not other forms
  • •E2 – able to eat lightly cooked egg (e.g. scrambled egg, boiled egg) but reacts to raw egg in uncooked cake mixtures, fresh mayonnaise, ice cream etc.
  • •3\.Written informed consent from parent/guardian (or the patient themselves from age 16 years), with assent from children aged 8 years and above wherever possible.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 730
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range 0

Exclusion Criteria

  • •1\.Clinical resolution of egg allergy
  • •2\.Contraindications to LAIV (notwithstanding allergy to egg protein):
  • •a.Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)
  • •b.Previous systemic allergic reaction to LAIV
  • •c.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
  • •d.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.
  • •e.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.
  • •3\.Contraindication to vaccination on that occasion, due to child being acutely unwell:
  • •a.Febrile \=38\.0oC in last 72 hours
  • •b.Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child’s treating healthcare professional

Outcomes

Primary Outcomes

Not specified

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