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Safety of Nasal Influenza Immunisation in Children With Asthma

NCT02866942 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 479

Last updated 2019-05-10

Study results available
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Summary

A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been approved by a number of licensing boards and is given by a spray into the nose. In the United Kingdom (UK), the vaccine has been demonstrated to be highly effective against influenza infection. Further, despite concerns that LAIV can cause wheezing in children under age 2 years, the previous SNIFFLE studies have demonstrated it to be safe in children over 2 years with mild-moderate asthma.

The objective of this multicentre study is to further assess the safety of intranasal LAIV in children with asthma and recurrent wheeze, including those with severe symptoms.

Conditions

Interventions

DRUG

Administration of Live attenuated influenza vaccine (LAIV)

Sponsors & Collaborators

  • Public Health England

    collaborator OTHER_GOV

  • Imperial College London

    lead OTHER

Principal Investigators

  • Paul J Turner · Imperial College London / Imperial College Healthcare NHS Trust / Public Health England

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-03-31
Completion
2017-03-31

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Entities

Diseases

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 NCT02866942 on ClinicalTrials.gov