MedTrace Logo

Efficacy & Safety of Nasal Influenza Immunisation in Children

NCT02549365 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2019-12-11

Study results available
· View outcomes & findings →

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

DRUG

Live attenuated influenza vaccine

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

PROCEDURE

Surveillance (nasal swabbing) during influenza season

Sponsors & Collaborators

  • Public Health England

    collaborator OTHER_GOV

  • Imperial College London

    lead OTHER

Principal Investigators

  • Paul J Turner · Imperial College London

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02549365 on ClinicalTrials.gov