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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02866942
Recruitment Status : Completed
First Posted : August 15, 2016
Results First Posted : April 26, 2019
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
Public Health England
Information provided by (Responsible Party):
Paul Turner, Imperial College London

Tracking Information
First Submitted Date  ICMJE August 4, 2016
First Posted Date  ICMJE August 15, 2016
Results First Submitted Date  ICMJE February 14, 2019
Results First Posted Date  ICMJE April 26, 2019
Last Update Posted Date May 10, 2019
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
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.
Change History Complete list of historical versions of study NCT02866942 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Children Receiving LAIV [ Time Frame: Up to 72 hours 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
  • Vaccine efficacy in the 2016/17 influenza season, through documentation of the incidence of laboratory confirmed influenza and other respiratory viruses in children receiving LAIV [ Time Frame: 6 months post LAIV ]
    Vaccine efficacy, through documentation of the incidence of laboratory confirmed influenza and other respiratory viruses in children receiving LAIV
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: August 10, 2016)
  • Asthma Control Questionnaire (ACQ) prior to LAIV [ Time Frame: 1 week ]
  • Inflammatory biomarkers pre- and post LAIV [ Time Frame: 4 weeks ]
    Fractional exhaled nitric oxide and assessment of induced sputum
 
Descriptive Information
Brief Title  ICMJE Safety of Nasal Influenza Immunisation in Children With Asthma
Official Title  ICMJE Safety of Nasal Influenza Immunisation in Children With Asthma - The SNIFFLE-4 Study
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Asthma
Intervention  ICMJE Drug: Administration of Live attenuated influenza vaccine (LAIV)
Other Names:
  • Flumist
  • Fluenz
Study Arms  ICMJE Experimental: Asthma
LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+
Intervention: Drug: Administration of Live attenuated influenza vaccine (LAIV)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2017)
479
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2016)
840
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02866942
Other Study ID Numbers  ICMJE 16SM3348
2016-002352-24 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Paul Turner, Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Public Health England
Investigators  ICMJE
Principal Investigator: Paul J Turner Imperial College London / Imperial College Healthcare NHS Trust / Public Health England
PRS Account Imperial College London
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP