Who is sponsoring NCT03600428?

NCT03600428 is sponsored by Vanderbilt University Medical Center.

What drugs are being tested in NCT03600428?

Interventions in NCT03600428: Live Attenuated Influenza Vaccine (LAIV), Inactivated Influenza Vaccine (IIV).

What condition does NCT03600428 study?

NCT03600428 studies Asthma in Children, Vaccine Adverse Reaction, Vaccine Reaction, Asthma, Wheezing, Influenza.

Is NCT03600428 still recruiting?

NCT03600428 is currently completed. Last updated 16 March 2021.

Are results published for NCT03600428?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-03-16 · How we verify

NCT03600428

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety of LAIV4 in Children With Asthma

Completed Phase 4 Results posted Last updated 16 March 2021

What this trial tests

Phase 4 trial testing Live Attenuated Influenza Vaccine (LAIV) in Asthma in Children in 152 participants. Completed in 20 March 2020.

Timeline

15 October 2018

Primary endpoint
20 March 2020

20 March 2020

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	152
Start date	15 October 2018
Primary completion	20 March 2020
Estimated completion	20 March 2020
Sites	3 locations across United States

Drugs / interventions tested

Live Attenuated Influenza Vaccine (LAIV) — full drug profile →
Inactivated Influenza Vaccine (IIV) — full drug profile →

Conditions studied

Asthma in Children — all drugs for Asthma in Children →
Vaccine Adverse Reaction — all drugs for Vaccine Adverse Reaction →
Vaccine Reaction — all drugs for Vaccine Reaction →
Asthma — all drugs for Asthma →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 5 to 11, any sex, with Asthma in Children or Vaccine Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 42 Days After LAIV4 vs. IIV4 (Until Day 43). Primary · Day 43

For this study, asthma exacerbation will be defined as: any acute episode of progressively worsening shortness of breath (dyspnea), cough, wheezing, chest tightness, and/or respiratory distress during the 42 days (until day 43) after influenza vaccination for which the patient seeks unscheduled medical attention (e.g., healthcare provider office or Emergency Department visit or hospitalization) or receives a new prescription for systemic corticosteroids.

Group	Value	95% CI
Live Attenuated Influenza Vaccine (LAIV4)	8
Inactivated Influenza Vaccine (IIV4)	10
Live Attenuated Influenza Vaccine (LAIV4)	66
Inactivated Influenza Vaccine (IIV4)	58

Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 14 Days After LAIV4 vs. IIV4 Secondary · Day 15

For this study, asthma exacerbation will be defined as: any acute episode of progressively worsening shortness of breath (dyspnea), cough, wheezing, chest tightness, and/or respiratory distress during the 14 days (until day 15) after influenza vaccination for which the patient seeks unscheduled medical attention (e.g., healthcare provider office or Emergency Department visit or hospitalization) or receives a new prescription for systemic corticosteroids.

Group	Value	95% CI
Live Attenuated Influenza Vaccine (LAIV4)	3
Inactivated Influenza Vaccine (IIV4)	4
Live Attenuated Influenza Vaccine (LAIV4)	73
Inactivated Influenza Vaccine (IIV4)	66

Comparison of the Proportion of Participants With Asthma Symptoms and Unscheduled Albuterol Use During the 14 Days After Receipt of LAIV4 or IIV4 (Each is Assessed Separately). Secondary · Day 15

Cough, wheezing, tightness in chest, nighttime awakening and unscheduled albuterol use will all be assessed by parent self-report

Asthma symptoms within 14 days

Group	Value	95% CI
Live Attenuated Influenza Vaccine (LAIV4)	18
Inactivated Influenza Vaccine (IIV4)	20
Live Attenuated Influenza Vaccine (LAIV4)	58
Inactivated Influenza Vaccine (IIV4)	50

Night-time awakening within 14 days

Group	Value	95% CI
Live Attenuated Influenza Vaccine (LAIV4)	55
Inactivated Influenza Vaccine (IIV4)	42
Live Attenuated Influenza Vaccine (LAIV4)	21
Inactivated Influenza Vaccine (IIV4)	28

Unscheduled Albuterol use within 14 days

Group	Value	95% CI
Live Attenuated Influenza Vaccine (LAIV4)	41
Inactivated Influenza Vaccine (IIV4)	44
Live Attenuated Influenza Vaccine (LAIV4)	35
Inactivated Influenza Vaccine (IIV4)	26

Cough, wheezing, tightness in chest, nighttime awakening and unscheduled albuterol use will all be assessed by parent self-report

Asthma related cough within 14 days

Group	Value	95% CI
Live Attenuated Influenza Vaccine (LAIV4)	26
Inactivated Influenza Vaccine (IIV4)	22
Live Attenuated Influenza Vaccine (LAIV4)	35
Inactivated Influenza Vaccine (IIV4)	29
Live Attenuated Influenza Vaccine (LAIV4)	14
Inactivated Influenza Vaccine (IIV4)	15
Live Attenuated Influenza Vaccine (LAIV4)	1
Inactivated Influenza Vaccine (IIV4)	4

Asthma related wheezing within 14 days

Group	Value	95% CI
Live Attenuated Influenza Vaccine (LAIV4)	51
Inactivated Influenza Vaccine (IIV4)	39
Live Attenuated Influenza Vaccine (LAIV4)	19
Inactivated Influenza Vaccine (IIV4)	18
Live Attenuated Influenza Vaccine (LAIV4)	5
Inactivated Influenza Vaccine (IIV4)	12
Live Attenuated Influenza Vaccine (LAIV4)	1
Inactivated Influenza Vaccine (IIV4)	1

Asthma related chest tightness within 14 days

Group	Value	95% CI
Live Attenuated Influenza Vaccine (LAIV4)	58
Inactivated Influenza Vaccine (IIV4)	45
Live Attenuated Influenza Vaccine (LAIV4)	12
Inactivated Influenza Vaccine (IIV4)	21
Live Attenuated Influenza Vaccine (LAIV4)	5
Inactivated Influenza Vaccine (IIV4)	3
Live Attenuated Influenza Vaccine (LAIV4)	1
Inactivated Influenza Vaccine (IIV4)	1

Comparison of the Proportion of Participants Who Experience a Clinically Significant Decrease in Peak Flow Measurement From Baseline During the 14 Days After LAIV4 or IIV4 Secondary · Baseline, Day 15

For purposes of this measure, a clinically significant decrease in peak flow is defined as: a decrease of ≥20% in PEFR from baseline PEFR

Group	Value	95% CI
Live Attenuated Influenza Vaccine (LAIV4)	36
Inactivated Influenza Vaccine (IIV4)	37
Live Attenuated Influenza Vaccine (LAIV4)	39
Inactivated Influenza Vaccine (IIV4)	33
Live Attenuated Influenza Vaccine (LAIV4)	1
Inactivated Influenza Vaccine (IIV4)	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Within 42 days (until day 43) after vaccination.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Live Attenuated Influenza Vaccine (LAIV4)

Serious: 0/74 (0%)

Deaths: 0/74

Inactivated Influenza Vaccine (IIV4)

Serious: 0/68 (0%)

Deaths: 0/68

Other adverse events (1 terms — click to expand)

Reaction	System	Live Attenuated Influenza …	Inactivated Influenza Vacc…
Asthma Exacerbation	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT03600428 adverse events section.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Safety of Live Attenuated Influenza Vaccine in Children With Asthma.
Sokolow AG, Stallings AP, Kercsmar C, Harrington T, et al · · 2022 · cited 10× · PMID 35342923 · DOI 10.1542/peds.2021-055432
Nanotechnology-driven advances in intranasal vaccine delivery systems against infectious diseases.
Zhang Z, Yang Y, Huang L, Yuan L, et al · · 2025 · cited 4× · PMID 40416956 · DOI 10.3389/fimmu.2025.1573037
Head-to-head comparison of influenza vaccines in children: a systematic review and meta-analysis.
Garai R, Jánosi Á, Krivácsy P, Herczeg V, et al · · 2024 · cited 3× · PMID 39367499 · DOI 10.1186/s12967-024-05676-9

Verify or expand the search:

Other recruiting trials for Asthma in Children

Currently open trials in the same condition.

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NCT07412769 — ASMact: Study on Management of Bronchial Asthma · recruiting
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NCT07137923 — SMART Implementation-Effectiveness Trial 1 · NA · recruiting
NCT06851715 — Improving Quality of Life for Teenagers With Asthma · NA · recruiting

Other Vanderbilt University Medical Center trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03600428 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University Medical Center
Last refreshed: 16 March 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03600428.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing