Is a nasal spray 'flu vaccine safe for use in children with severe asthma/wheezing?
- Conditions
- Children aged 2-18 years (inclusive), with asthma / recurrent wheezing.MedDRA version: 20.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2016-002352-24-GB
- Lead Sponsor
- Imperial College Healthcare NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 478
1.Aged 2 – 18 years old
2.Physician diagnosis of asthma or recurrent wheezing (by the hospital specialist)
3.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: 840
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1.Admission to PICU for respiratory illness in the preceding 2 years.
2.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
3.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.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.
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.
Administration of another live vaccine (e.g. MMR) within the previous 4 weeks is no longer a contra-indication to LAIV administration, according to updated DoH guidelines.
NB: See Summary of Product Characteristics for full details of contra-indications to LAIV.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method