Is a nasal spray 'flu vaccine effective and safe for use in children, including those with asthma/wheezing?

Phase 1

• Conditions: Children aged 2-18 years (inclusive), some of whom will have asthma and/or food allergies.; MedDRA version: 18.0 Level: LLT Classification code 10001738 Term: Allergy System Organ Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-003019-39-GB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-15
• Study Completion: 2016-05-27
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 276

Inclusion Criteria

1.Aged 2 – 18 years.

2.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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

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

a.Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue)
b.Previous systemic allergic reaction to LAIV
c.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
d.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 of prednisolone at 20mg or more per day (any age); or for children under 20kg, a dose of 1mg/kg/day or more.

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.

e.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.
f.pregnancy

2.Contraindication to vaccination on that occasion, e.g. due to child being acutely unwell:

a.Febrile =38.0oC in last 72 hours
b.Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child’s treating healthcare professional
c.Recent admission to hospital in last 2 weeks for acute asthma
d.Current oral steroid for asthma exacerbation or course completed within last 2 weeks
e.Received any blood or blood products within the past 12 weeks
f.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.

Recent antihistamine use is not a contra-indication to LAIV administration, but use of any antihistamine in the 96 hours prior to LAIV will be logged on the CRF.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: Is the intranasal LAIV influenza ('flu) vaccine effective in children?<br> ;<br> Secondary Objective: 1) Do laboratory tests (both blood test and a nasal swab) correlate with vaccine effectiveness?<br> 2) Is the intranasal LAIV influenza ('flu) vaccine effective and safe in children, including those with asthma / a history of recurrent wheezing?<br> ;Primary end point(s): Incidence of laboratory confirmed influenza and other respiratory viruses in participants receiving LAIV, compared to their unvaccinated sibling controls.;Timepoint(s) of evaluation of this end point: Up to the end of the influenza season (end March 2016)