Safety of LAIV4 in Children With Asthma

Phase 4 Completed 152 enrolled Vanderbilt University Medical Center Centers for Disease Control and Prevention · collab Children's Hospital Medical Center, Cincinnati · collab Duke University · collab

RandomizedParallel-groupOpen-labelPrevention

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).

Timeline

Start: 2018-10-15
Primary completion: 2020-03-20
Completion: 2020-03-20

Publications

Sokolow AG, Stallings AP, Kercsmar C, Harrington T, Jimenez-Truque N, Zhu Y, Sokolow K, Moody MA, Schlaudecker EP, Walter EB, Staat MA, Broder KR, Creech CB. Safety of Live Attenuated Influenza Vaccine in Children With Asthma. Pediatrics. 2022 Apr 1;149(4):e2021055432. doi: 10.1542/peds.2021-055432.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FluMist	Vaccine	0.2 ml	Intranasal
Comparator	Influenza Virus Vaccine	Vaccine	0.5 ml	Intramuscular

Safety of LAIV4 in Children With Asthma

Summary

Timeline

Publications

Drugs

Indications