Safety of LAIV4 in Children With Asthma

Status Completed

Clinical Trial 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).

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03600428
Study type	Interventional
Source	Vanderbilt University Medical Center
Contact
Status	Completed
Phase	Phase 4
Start date	October 15, 2018
Completion date	March 20, 2020

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04410523` - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma	Phase 2
Completed	`NCT04624425` - Additional Effects of Segmental Breathing In Asthma	N/A
Active, not recruiting	`NCT03927820` - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)	N/A
Completed	`NCT04617015` - Defining and Treating Depression-related Asthma	Early Phase 1
Recruiting	`NCT03694158` - Investigating Dupilumab's Effect in Asthma by Genotype	Phase 4
Terminated	`NCT04946318` - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma	Phase 2
Completed	`NCT04450108` - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients	N/A
Completed	`NCT03086460` - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)	Phase 2
Completed	`NCT01160224` - Oral GW766944 (Oral CCR3 Antagonist)	Phase 2
Completed	`NCT03186209` - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)	Phase 3
Completed	`NCT02502734` - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma	Phase 3
Completed	`NCT01715844` - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics	Phase 1
Terminated	`NCT04993443` - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036	Phase 1
Completed	`NCT02787863` - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology	Phase 4
Recruiting	`NCT06033833` - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study	Phase 2
Completed	`NCT03257995` - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.	Phase 2
Completed	`NCT02212483` - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients	N/A
Recruiting	`NCT04872309` - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn	`NCT01468805` - Childhood Asthma Reduction Study	N/A
Recruiting	`NCT05145894` - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device