Safety of Nasal Influenza Immunisation in Children With Asthma (SNIFFLE-4)
|ClinicalTrials.gov Identifier: NCT02866942|
Recruitment Status : Completed
First Posted : August 15, 2016
Results First Posted : April 26, 2019
Last Update Posted : May 10, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Administration of Live attenuated influenza vaccine (LAIV)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||479 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety of Nasal Influenza Immunisation in Children With Asthma - The SNIFFLE-4 Study|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+
Drug: Administration of Live attenuated influenza vaccine (LAIV)
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866942
|Principal Investigator:||Paul J Turner||Imperial College London / Imperial College Healthcare NHS Trust / Public Health England|