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LAIV4 Safety in Children with Asthma
NCT03600428Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2018
- Primary completion
- Mar 2020
- Countries
- 1
- Sponsor
- Vanderbilt University Medical Center
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- influenza
01
Overview
Phase 4, randomised, open-label trial of live attenuated influenza vaccine in influenza (2 arms), sponsored by Vanderbilt University Medical Center. Primary endpoint: Proportion of Participants Experiencing an Asthma Exacerbation at 43 days. Started Oct 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
LAIV4 Arm
Participants receive one dose of quadrivalent live attenuated influenza vaccine via intranasal spray.
IIV4 Arm
Participants receive one dose of quadrivalent inactivated influenza vaccine via intramuscular injection.
03
Who it enrols
Children aged 5-11 with a current diagnosis of persistent asthma requiring long-acting controller medication, in good health otherwise, excluding those with recent acute illness, immunosuppression, or history of severe vaccine allergy.
04
Endpoints
Primary
Proportion of Participants Experiencing an Asthma Exacerbation
Secondary
Proportion of Participants Experiencing an Asthma Exacerbation
Proportion of Participants With Asthma Symptoms
Proportion of Participants With Unscheduled Albuterol Use
Proportion of Participants Who Experience a Clinically Significant Decrease in Peak Flow Measurement
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