CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 276 enrolled
Drug / intervention
Live attenuated influenza vaccine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02549365
NCT02549365Phase 4Completed

Efficacy & Safety of Nasal Influenza Immunisation in Children - The SNIFFLE-3 Study

Imperial College London·interventional·Posted Sep 15, 2015·Updated Dec 11, 2019

In Brief

A Phase 4 clinical trial evaluating Live attenuated influenza vaccine and Surveillance (nasal swabbing) during influenza season for Influenza Vaccines Efficacy and Safety. Completed, enrolled 276 participants across 1 site.

Detailed Summary

The UK Departments of Health now recommend annual influenza vaccination for all children 2-7 years of age, with children over 7 years eligible for vaccination if in certain higher risk clinical categories. Though data are available documenting the safety and immunogenicity of LAIV in this age group, there are little data to assess efficacy and immune correlates in UK children, and in particular atopic children. This study will enrol 200 children (and at least 200 unvaccinated household sibling controls), many with a history of asthma or recurrent wheezing, and allow an assessment of efficacy, safety and immune correlates in these children, and how this varies with prior administration of pandemic influenza vaccine and/or LAIV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 15, 2015
Enrollment StartOct 1, 2015
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.8 years ago

Interventions

Live attenuated influenza vaccinedrug

Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season

Surveillance (nasal swabbing) during influenza seasonprocedure