Safety of LAIV4 in Children With Asthma

NCT03600428 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 181211200-2012-50430 Task Order 0005
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

asthma; influenza vaccine; inactivated influenza vaccine; live attenuated influenza vaccine

Outcome Measures

Primary Outcomes (1)

• Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 42 Days After LAIV4 vs. IIV4 (Until 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.

  Day 43

Secondary Outcomes (3)

• Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 14 Days After LAIV4 vs. IIV4

  Day 15

• 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).

  Day 15

• 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

  Baseline, Day 15

Study Arms (2)

Live Attenuated Influenza Vaccine (LAIV)

EXPERIMENTAL

Participants will receive one dose of live attenuated influenza vaccine via intranasal spray (administer approximately one half of the contents of the single-dose intranasal sprayer into each nostril, each sprayer contains 0.2 mL of vaccine)).

Biological: Live Attenuated Influenza Vaccine (LAIV)

Inactivated Influenza Vaccine (IIV)

ACTIVE COMPARATOR

Participants will receive one dose of inactivated influenza vaccine via intramuscular injection (0.5 mL).

Biological: Inactivated Influenza Vaccine (IIV)

Interventions

Live Attenuated Influenza Vaccine (LAIV) BIOLOGICAL

1 dose, 0.2 mL, intranasal administration

Live Attenuated Influenza Vaccine (LAIV)

Inactivated Influenza Vaccine (IIV) BIOLOGICAL

1 dose, 0.5 mL, intramuscular administration

Inactivated Influenza Vaccine (IIV)

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 preceding 24 hours that might mask a fever (this may result in a temporary delay of vaccination)
• History of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any influenza vaccine or after any component of the influenza vaccine, including egg protein.
• Receipt of any licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to vaccination or planned receipt of any licensed vaccine within 42 days after vaccination
• Receipt of current year's (2018-2019 influenza season) licensed influenza vaccine for children 9-11 years (only). (Clarification: Children aged 5-8 years are permitted to be enrolled if they have received zero or one dose of the 2018-2019 influenza season vaccine, and require two doses of the 2018-2019 influenza vaccine.)
• Received an investigational agent (licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) in the 28 days prior to enrollment or planned receipt before 42 days after vaccination
• Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months
• Have taken ≥20mg/day of prednisone or its equivalent, for 14 days or more within the past 28 days
• Have known active neoplasm or a history of any hematologic malignancy
• Has had a previous exacerbation of their asthma symptoms requiring systemic steroids within the prior 28 days, or has had a life-threatening exacerbation of asthma in the past two years (e.g. hypoxic seizure, mechanical ventilation)
• Received influenza antiviral medication within 48 hours prior to study vaccination
• History of Guillian-Barré syndrome within 6 weeks of previous influenza vaccination
• Have any condition that, in the opinion of the investigator, would interfere with the evaluation of the responses or would place the participant at unacceptable risk of injury
• Has a positive urine or serum pregnancy test within 24 hours prior to vaccination in a post-menarchal female. LAIV is not recommended for use in pregnant females.
• Currently taking aspirin or aspirin-containing products

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Centers for Disease Control and Prevention: collaborator
• Duke University: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (3)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 35342923 DERIVED

MeSH Terms

Conditions

Asthma; Respiratory Sounds; Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: C. Buddy Creech, MD, MPH
• Organization: Vanderbilt University Medical Center

buddy.creech@vumc.org

6153430332

Study Officials

• Buddy Creech, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 26, 2018
• Study Start: October 15, 2018
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: March 16, 2021
• Results First Posted: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)