EUCTR2015-003019-39-GB
Active, not recruiting
Phase 1
Efficacy & Safety of Nasal Influenza Immunisation in Children - The SNIFFLE-3 study - SNIFFLE-3 Study
Not provided0 sites276 target enrollmentJuly 15, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Children aged 2-18 years (inclusive), some of whom will have asthma and/or food allergies.
- Sponsor
- Not provided
- Enrollment
- 276
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Aged 2 – 18 years.
- •2\.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: 200
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range 0
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range 0
Exclusion Criteria
- •1\.Contraindications to LAIV (notwithstanding allergy to egg protein), which include:
- •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\*.
- •\*High\-dose steroids is defined as a treatment course for at least one month, equivalent to a dose of prednisolone at 20mg or more per day (any age); or for children under 20kg, a dose of 1mg/kg/day or more.
- •NB: LAIV is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled/low\-dose oral 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.
- •f.pregnancy
- •2\.Contraindication to vaccination on that occasion, e.g. due to child being acutely unwell:
Outcomes
Primary Outcomes
Not specified
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