- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02549365
Efficacy & Safety of Nasal Influenza Immunisation in Children (SNIFFLE-3)
Efficacy & Safety of Nasal Influenza Immunisation in Children - The SNIFFLE-3 Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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London, United Kingdom, W2 1NY
- Imperial College London / Imperial College Healthcare NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 2 - 18 years old
- Written informed consent from parent/guardian (or patient themselves from age 16 years), with assent from children aged 8 years and above wherever possible.
Exclusion Criteria:
- Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue) [notwithstanding allergy to egg protein]
- 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**.
**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.
- 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.
- pregnancy
- Febrile ≥ 38.0 'C 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
- Received any blood or blood products within the past 12 weeks
- Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Administration of Live attenuated influenza vaccine (LAIV) as per national guidance.
Surveillance thereafter through nasal swabbing in the event of influenza-like illness.
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Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season
Other Names:
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Other: Controls
Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vaccine Efficacy
Time Frame: During 2015/2016 influenza season - precise dates to be set by Public Health England as this varies annually. Approximate duration of 3 months
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Vaccine efficacy will be assessed through documentation of the incidence of laboratory confirmed influenza and other respiratory viruses in the children receiving LAIV compared to unvaccinated sibling controls
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During 2015/2016 influenza season - precise dates to be set by Public Health England as this varies annually. Approximate duration of 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune Response to LAIV
Time Frame: Up to 6 weeks following administration of a single dose of LAIV
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To assess the immune response to vaccine and non-vaccine influenza strains before and after a single dose of LAIV administration, with respect to i. serological measures (haemagglutination inhibition titre to specific influenza strain) ii.
change in specific nasal IgA responses
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Up to 6 weeks following administration of a single dose of LAIV
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Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Those Received LAIV
Time Frame: Up to 1 month after LAIV administration
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Incidence of adverse events (AE) and serious adverse events (SAEs) in children receiving LAIV, with the following sub-analyses:
NB: AE data was NOT collected in household controls, as per protocol NB: AE delay not collected in Controls (as per protocol) |
Up to 1 month after LAIV administration
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul J Turner, Imperial College London
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15SM2801
- 2015-003019-39 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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