A Phase 4 interventional study of Administration of Live attenuated influenza vaccine (LAIV) in Asthma, sponsored by Imperial College London. Completed. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-05-10.
Sponsored by Imperial College London · Phase 4, Interventional, and Prevention
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.
3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 479 is above the median of 83 across 2,751 interventional studies indexed under Asthma.
Browse Asthma studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
Contraindications to LAIV (notwithstanding allergy to egg protein), which include:
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.
Contraindications to vaccination on that occasion, e.g. due to child being acutely unwell:
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.
LAIV administration in children with asthma receiving treatment according to British Thoracic Society step 2+
Drug: Administration of Live attenuated influenza vaccine (LAIV)
Also known as: Flumist, Fluenz
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.
Time frame: 4 weeks post LAIV
Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Children Receiving LAIV
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
Time frame: Up to 4 weeks post LAIV administration
| Milestone | Asthma |
|---|---|
| Started | 479 |
| Completed | 478 |
| Not completed | 1 |
| Withdrew: Invalid consent | 1 |
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.
| Participants | Asthma |
|---|---|
| Improvement >= MID | 28 |
| No change | 254 |
| Deterioration >= MID | 37 |
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
| Participants | Asthma |
|---|---|
| Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Children Receiving LAIV | 47 |
Collected over 72 hours post LAIV administration. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Asthma | 0/478 (0%) | 4/478 (0.8%) | 150/478 (31.4%) |
| Event | Asthma |
|---|---|
| WheezingRespiratory, thoracic and mediastinal disorders | 4/478 |
| Event | Asthma |
|---|---|
| RhinitisRespiratory, thoracic and mediastinal disorders | 54/478 |
| MalaiseGeneral disorders | 42/478 |
| CoughRespiratory, thoracic and mediastinal disorders | 27/478 |
| WheezingRespiratory, thoracic and mediastinal disorders | 27/478 |
| Age, Categorical(Participants) | Asthma |
|---|---|
| <=18 years | 476 |
| Between 18 and 65 years | 2 |
| >=65 years | 0 |
| Age, Continuous(years) | Asthma |
|---|---|
| Median | 9.3 (2.0 to 18.7) |
| Sex: Female, Male(Participants) | Asthma |
|---|---|
| Female | 190 |
| Male | 288 |
| Race and Ethnicity Not Collected(Participants) | Asthma |
|---|
| Region of Enrollment(participants) | Asthma |
|---|---|
| United Kingdom | 478 |
| British Thoracic Society (BTS) Treatment Step 4+(Participants) | Asthma |
|---|---|
| Count of participants | 229 |
No study locations are listed for this record.
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Imperial College London