Safety of Nasal Influenza Immunisation in Children With Asthma

NCT02866942 | Completed Phase 4 Results DMC

• 2 other identifiers: 16SM33482016-002352-24
• Study Type: interventional
• Target: 479
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Change in Asthma Symptoms and Control Pre and 4 Weeks Post LAIV, as Assessed by Validated Questionnaire

  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 Outcomes (1)

• Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Children Receiving LAIV

  Up to 4 weeks post LAIV administration

Study Arms (1)

Asthma

EXPERIMENTAL

LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+

Drug: Administration of Live attenuated influenza vaccine (LAIV)

Interventions

Administration of Live attenuated influenza vaccine (LAIV) DRUG

Also known as: Flumist, Fluenz

Asthma

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Admission to Paediatric Intensive Care for invasive ventilation due to a respiratory illness in the preceding 2 years.
• Contraindications to LAIV (notwithstanding allergy to egg protein), which include:
• Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)
• Previous systemic allergic reaction to LAIV
• 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
• 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.
• 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.
• pregnancy
• Contraindications to vaccination on that occasion, e.g. due to child being acutely unwell:
• Febrile ≥38.0 degrees C in last 72 hours
• \*Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child's treating healthcare professional
• \*Recent admission to hospital in last 2 weeks for acute asthma
• \*Current oral steroid for asthma exacerbation or course completed within last 2 weeks

Sponsors & Collaborators

• Imperial College London: lead
• Public Health England: collaborator

Related Publications (3)

• Turner PJ, Southern J, Andrews NJ, Miller E, Erlewyn-Lajeunesse M; SNIFFLE Study Investigators. Safety of live attenuated influenza vaccine in atopic children with egg allergy. J Allergy Clin Immunol. 2015 Aug;136(2):376-81. doi: 10.1016/j.jaci.2014.12.1925. Epub 2015 Feb 13.

  PMID: 25684279 BACKGROUND

• Turner PJ, Southern J, Andrews NJ, Miller E, Erlewyn-Lajeunesse M; SNIFFLE-2 Study Investigators. Safety of live attenuated influenza vaccine in young people with egg allergy: multicentre prospective cohort study. BMJ. 2015 Dec 8;351:h6291. doi: 10.1136/bmj.h6291.

  PMID: 26645895 BACKGROUND

• Jackson D, Pitcher M, Hudson C, Andrews N, Southern J, Ellis J, Hoschler K, Pebody R, Turner PJ, Miller E, Zambon M. Viral Shedding in Recipients of Live Attenuated Influenza Vaccine in the 2016-2017 and 2017-2018 Influenza Seasons in the United Kingdom. Clin Infect Dis. 2020 Jun 10;70(12):2505-2513. doi: 10.1093/cid/ciz719.

  PMID: 31642899 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

FluMist

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr Paul Turner
• Organization: Imperial College London

p.turner@imperial.ac.uk

+44 20 3312 7754

Study Officials

• Paul J Turner

  Imperial College London / Imperial College Healthcare NHS Trust / Public Health England

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MRC Clinician Scientist

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 15, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 10, 2019
• Results First Posted: April 26, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share