Safety of LAIV4 in Children With Asthma (NCT03600428) | Clinical Trial Compass
CompletedPhase 4
Safety of LAIV4 in Children With Asthma
United States152 participantsStarted 2018-10-15
Plain-language 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).
Who can participate
Age range5 Years – 11 Years
SexALL
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Inclusion Criteria:
* Children between 5-11 years of age, inclusive, at enrollment
* Participant must have a current diagnosis of persistent asthma (Physician diagnosis of asthma and current prescribed use of a long-acting controller medication. For purposes of this study, we have considered "controller" medications to be any single or combination use of long-acting medications used to prevent asthma exacerbations and to achieve long-term control of asthma (as compared to short-acting rescue medication).)
* Parent(s) or legal guardian(s) must provide written, informed consent and participant must provide assent as appropriate for age prior to initiation of study procedures and according to local IRB requirements
* Parent(s) or legal guardian(s) and participant must be willing and able to comply with planned study procedures and be available for all study visits
* Is in good health, other than their asthma, as determined by medical history
* English or Spanish literate (only English-speaking participants will be included at the Cincinnati and Duke sites)
* Intention of being available for entire study period and complete all relevant study procedures, including follow-up using at least one of the following methods: phone calls, text messages, or emails
Exclusion Criteria:
* Acute illness and/or a reported oral temperature of ≥ 100.4°F within 72 hours prior to enrollment (this may result in a temporary delay of vaccination)
* Use of antipyretic medication during the precedin…
What they're measuring
1
Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 42 Days After LAIV4 vs. IIV4 (Until Day 43).