Safety of Nasal Influenza Immunisation in Children With Asthma (SNIFFLE-4)

May 8, 2019 updated by: Paul Turner, Imperial College London

Safety of Nasal Influenza Immunisation in Children With Asthma - The SNIFFLE-4 Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

479

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 2 - 18 years old (inclusive)
  • Physician diagnosis of asthma or recurrent wheezing (by the hospital specialist) AND (i) in children age 2-4 years: ≥2 exacerbations in the past year requiring oral steroids or observation in-hospital beyond 4 hours duration, OR (ii) in children ≥ 5 years of age, receiving treatment equivalent to at least BTS/SIGN step 2 therapy.
  • Written informed consent from parent/guardian (or the patient themselves from age 16 years), with assent from children aged 8 years and above wherever possible.

Exclusion Criteria:

  1. Admission to Paediatric Intensive Care for invasive ventilation due to a respiratory illness in the preceding 2 years.

  2. Contraindications to LAIV (notwithstanding allergy to egg protein), which include:

    1. Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)
    2. Previous systemic allergic reaction to LAIV
    3. 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

    4. 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 greater than 20mg prednisolone per day (any age), or for children under 20kg, a dose greater than 1mg/kg/day.

      NB: LAIV is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled/low-dose oral systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.

    5. 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.
    6. pregnancy

  3. Contraindications to vaccination on that occasion, e.g. due to child being acutely unwell:

    1. Febrile ≥38.0 degrees C in last 72 hours
    2. *Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child's treating healthcare professional
    3. *Recent admission to hospital in last 2 weeks for acute asthma
    4. *Current oral steroid for asthma exacerbation or course completed within last 2 weeks

    5. 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.

      • Items 3b-3d are relative contra-indications: Many children with "difficult-to-control" symptoms may meet fail to meet these criteria on a routine basis. Where these are present, the study centre PIs are able to authorise participation on a case-by-case basis, after assessing the child and their lung function at the time of enrolment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Asthma
LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+
Drug: Administration of Live attenuated influenza vaccine (LAIV)
Other Names:
  • Fluenz
  • Flumist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Asthma Symptoms and Control Pre and 4 Weeks Post LAIV, as Assessed by Validated Questionnaire
Time Frame: 4 weeks post LAIV

The validated questionnaire to be used will depend on the age of the enrolled child:

  • Age 2-4 years: TRACK questionnaire
  • Age 5-11 years: Children's Asthma Control Test (C-ACT) score
  • Age 12+ years: Asthma Control Test (ACT) score

The change in score (using the appropriate questionnaire for age) between pre- and 4 weeks post LAIV will be used to assess the primary outcome across all participants. a change in (c-)ACT of at least 3 points, or 10 points for TRACK will be determined a significant change.

For TRACK, the minimum and maximum score possible is 0 and 100 respectively, the higher the score, the better is symptom control.

For c-ACT, the minimum and maximum score possible is 0 and 27 respectively, the higher the score, the better controlled are asthma symptoms.

For ACT, the minimum and maximum score possible is 5 and 25 respectively, the higher the score, the better controlled are asthma symptoms.
4 weeks post LAIV

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Children Receiving LAIV
Time Frame: Up to 4 weeks post LAIV administration

Incidence of a 'significant exacerbation' in asthma, defined as:

i. At least 3 day course of oral steroids following an unscheduled contact with a healthcare professional; OR ii. Unscheduled visit to an Emergency department or admission to hospital for treatment of asthma symptoms, requiring systemic corticosteroids
Up to 4 weeks post LAIV administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Public Health England

Investigators

  • Principal Investigator: Paul J Turner, Imperial College London / Imperial College Healthcare NHS Trust / Public Health England

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 15, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2019

Last Update Submitted That Met QC Criteria

May 8, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16SM3348
  • 2016-002352-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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