At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 152 enrolled
Drug / intervention
Live Attenuated Influenza Vaccine (LAIV) +1 morebiological
Likely dose
Live Attenuated Influenza Vaccine (LAIV) 0.2 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Study of the Safety of Quadrivalent Live Attenuated Influenza Vaccine (LAIV4) in Children With Asthma of Varying Levels of Severity
In Brief
A Phase 4 clinical trial evaluating Live Attenuated Influenza Vaccine (LAIV) and Inactivated Influenza Vaccine (IIV) for Asthma in Children and 5 related conditions. Completed, enrolled 152 participants across 3 sites.
Detailed Summary
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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma in Children, Vaccine Adverse Reaction, Vaccine Reaction, Asthma, Wheezing, Influenza
CountriesUnited States
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJul 2018
Enrollment StartOct 2018
Primary CompletionMar 2020
TodayJul 2026
First PostedJul 26, 2018
Enrollment StartOct 15, 2018
Primary CompletionMar 20, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.9 years ago
Interventions
Live Attenuated Influenza Vaccine (LAIV)biological
1 dose, 0.2 mL, intranasal administration
Inactivated Influenza Vaccine (IIV)biological
1 dose, 0.5 mL, intramuscular administration