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Safety of LAIV4 in Children With Asthma

NCT03600428 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2021-03-16

Study results available
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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).

Conditions

  • Asthma in Children
  • Vaccine Adverse Reaction
  • Vaccine Reaction
  • Asthma
  • Wheezing
  • Influenza

Interventions

BIOLOGICAL

Live Attenuated Influenza Vaccine (LAIV)

1 dose, 0.2 mL, intranasal administration

BIOLOGICAL

Inactivated Influenza Vaccine (IIV)

1 dose, 0.5 mL, intramuscular administration

Sponsors & Collaborators

Principal Investigators

  • Buddy Creech, MD, MPH · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2020-03-20
Completion
2020-03-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03600428 on ClinicalTrials.gov