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Clinical Trials/EUCTR2013-002031-26-GB
EUCTR2013-002031-26-GB
Active, not recruiting
Phase 1

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

niversity Hospitals Southampton NHS Foundation Trust0 sites300 target enrollmentMay 30, 2013
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DrugsFluenz nasal spray suspension Influenza vaccine

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity Hospitals Southampton NHS Foundation Trust
Enrollment
300
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 30, 2013
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity Hospitals Southampton NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

  • •1\. Aged 2 – 17 years old inclusive
  • •2\. Physician\-diagnosis of egg allergy on the basis of:
  • •a. Positive oral food challenge to egg (conducted under medical supervision) within the last 6 months; OR
  • •b. History of convincing clinical reaction AND positive skin prick test to ovalbumin at visit 1; OR
  • •c. Evidence of \>95% likelihood of egg allergy (on the basis of serum specific IgE or skin prick test (SPT) to ovalbumin within past 12 months) (15\) but with no prior history of exposure to egg AND positive skin prick test to ovalbumin at visit 1
  • •3\. Written informed consent from parent/guardian \+/\- assent from the child.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 300
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range 0

Exclusion Criteria

  • •1\. Contraindicated as acutely unwell or current unstable asthma
  • •a. Acute wheeze in last 72 hours requiring treatment
  • •b. Febrile \=38\.0oC in last 72 hours
  • •c. Recent admission to hospital in last 2 weeks for acute asthma
  • •2\. Current medication
  • •a. Use of asthma reliever medication in last 72 hours
  • •b. Recent administration of a medication containing antihistamine within the last 4 days
  • •c. Current oral steroid for asthma exacerbation or course completed within last 2 weeks
  • •3\. Contraindications to LAIV (notwithstanding allergy to egg protein):
  • •a. Hypersensitivity to the active ingredients, to gelatin or to gentamicin (a possible trace residue)

Outcomes

Primary Outcomes

Not specified

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