NCT02549365

Efficacy & Safety of Nasal Influenza Immunisation in Children

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza Vaccines Efficacy and Safety

Interventions

Type	Name	Description
DRUG	Live attenuated influenza vaccine	Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season
PROCEDURE	Surveillance (nasal swabbing) during influenza season

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-09-15
• Last updated: 2019-12-11
• Results posted: 2019-11-27

Locations

1 site across 1 country: United Kingdom