This is a prospective randomized, open label clinical trial in approximately 300 children aged 5-11 years with a physician diagnosis of persistent asthma. Participants will be randomized 1:1 to receive either a single intranasal dose of licensed quadrivalent LAIV (LAIV4) or an intramuscular injection of quadrivalent IIV4 (IIV4).
The study will be conducted at three sites: Vanderbilt University Medical Center (Lead site), Cincinnati Children's Hospital Medical Center (contributing site), and Duke University Medical Center (contributing site) during the 2018-2019 influenza season. Participants will be randomized 1:1 to receive either a single intranasal dose of licensed quadrivalent LAIV (LAIV4) or an intramuscular injection of quadrivalent IIV4 (IIV4), stratifying by asthma severity (mild vs. moderate-to-severe). Vanderbilt will enroll about 100 participants, Cincinnati will enroll about 110 participants, and Duke will enroll about 90 participants. After enrollment, participants will be followed for 43 days via 5 additional phone, email, or text visits to monitor systemic reactogenicity, asthma symptoms and exacerbations, and serious adverse events. The primary objective is to compare proportions of participants with asthma exacerbations during the 42 days after LAIV4 versus IIV4. Because of the potential for increased risk of wheezing after LAIV, the use of LAIV in persons with asthma has been an area of vaccine safety research for many years; the safety issue remains unresolved. A clinical study to assess the safety of LAIV4 in children with asthma could expand the evidence base and inform clinical decision-making and public health policy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
152
1 dose, 0.2 mL, intranasal administration
1 dose, 0.5 mL, intramuscular administration
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 42 Days After LAIV4 vs. IIV4 (Until Day 43).
For this study, asthma exacerbation will be defined as: any acute episode of progressively worsening shortness of breath (dyspnea), cough, wheezing, chest tightness, and/or respiratory distress during the 42 days (until day 43) after influenza vaccination for which the patient seeks unscheduled medical attention (e.g., healthcare provider office or Emergency Department visit or hospitalization) or receives a new prescription for systemic corticosteroids.
Time frame: Day 43
Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 14 Days After LAIV4 vs. IIV4
For this study, asthma exacerbation will be defined as: any acute episode of progressively worsening shortness of breath (dyspnea), cough, wheezing, chest tightness, and/or respiratory distress during the 14 days (until day 15) after influenza vaccination for which the patient seeks unscheduled medical attention (e.g., healthcare provider office or Emergency Department visit or hospitalization) or receives a new prescription for systemic corticosteroids.
Time frame: Day 15
Comparison of the Proportion of Participants With Asthma Symptoms and Unscheduled Albuterol Use During the 14 Days After Receipt of LAIV4 or IIV4 (Each is Assessed Separately).
Cough, wheezing, tightness in chest, nighttime awakening and unscheduled albuterol use will all be assessed by parent self-report
Time frame: Day 15
Comparison of the Proportion of Participants Who Experience a Clinically Significant Decrease in Peak Flow Measurement From Baseline During the 14 Days After LAIV4 or IIV4
For purposes of this measure, a clinically significant decrease in peak flow is defined as: a decrease of ≥20% in PEFR from baseline PEFR
Time frame: Baseline, Day 15
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