Influenza Vaccine Feasibility Study in Children With Persistent Asthma

NCT02967393 | Completed Phase 4 Results

• 1 other identifier: IIV4/LAIV4/CDC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

This study is designed to note whether a larger safety study using quadrivalent live attenuated influenza vaccine (LAIV4) versus quadrivalent inactivated influenza vaccine (IIV4)(FLUARIX®), would be feasible in children with persistent asthma. Half of the patients in this study will receive the FLUARIX® influenza vaccine, while the other half will receive a cell cultured quadrivalent inactivated influenza vaccine (ccIIV4)(Flucelvax®) being used as a surrogate for LAIV4.

Conditions

Asthmatic

Outcome Measures

Primary Outcomes (11)

• Feasibility Benchmark: Number of Parents That Complete the Memory Aid 1.

  Memory aid 1 is a diary completed by the subjects Parent. Daily symptoms, peak flow and requires the parent to record daily symptoms, peak flow, days, post-vaccination asthma clinical symptoms and symptom scores, adverse event, fever and concomitant medication administration data for 14 days (until day 15) after vaccination.

  15 days

• Feasibility Benchmark: Number of Parent Completing Collection of Adverse Event Data

  Parent will collect the following data: need for new prescription or nonprescription medications for the control of asthma, an unscheduled healthcare provider visit or consultation within 42 days after vaccination, any other clinically significant event occurring at any point during the study period. Serious Adverse Events (SAEs) will also be monitored through 42 days after vaccination and will include events that result in death, were life threatening, result in subject hospitalization or prolongation of existing hospitalization, result in persistent or significant disability or incapacity. Additionally, important medical events that may not have resulted in death, were not life threatening, or did not require hospitalization might be considered SAEs when, according to appropriate medical judgment, they jeopardize the patient or subject and require medical or surgical intervention to prevent one of the outcomes listed above.

  Day 16 to 43

• Feasibility Benchmark: Number of Parents That Perform and Document All Home Digital Peak Flow Measurements

  Number of parents that perform and document all home digital peak flow measurements at least 11 days out of the 15-day monitoring period.

  15 days

• Feasibility Benchmark: Number of Parents That Perform and Document the Digital Peak Flow for Day 42

  Parent will perform and document the digital peak flow for Day 42

  Day 42

• Feasibility Benchmark: Number of Parents That Document Nighttime Awakenings

  Number of parents that document nighttime awakenings for at least 11 of the 15-day monitoring period.

  15 days

• Feasibility Benchmark: Number of Parents That Respond to Day 4 Call and Provide Requested Data

  Number of parents that respond to Day 4 ( -1 day or + 2 days) call and provide requested data

  Day 3 to 6

• Feasibility Benchmark: Number of Parents That Respond to Day 8 Call and Provide Requested Data.

  Number of parents that respond to Day 8 (plus 2 days) call and provide requested data.

  Day 8-10

• Feasibility Benchmark: Number of Parents That Respond to Day 15 Call and Provide Requested Data

  Number of parents that respond to Day 15 (minus 1 or plus 2 days) call and provide requested data

  Day 14 to 17

• Feasibility Benchmark: Number of Parents That Respond to Day 29 Call and Provide Requested Data.

  Number of Parents that respond to Day 29 ( Plus 2 Days) call and provide requested data.

  Day 29-31

• Feasibility Benchmark: Number of Parents That Respond to Day 44 Call

  Number of parents that respond to Day 44 ( Plus 3 Days) call and provide requested data.

  Day 44-47

• Feasibility Benchmark: Number of Parents Completing a Satisfaction Survey

  Parent of each participant will be asked to complete a at the end of the study

  42 days

Secondary Outcomes (5)

• Severe Local Reactogenicity Events During the 14 Days Post-vaccination

  14 days

• Severe Systemic Reactogenicity Events During the 14 Days Post-vaccination

  14 days

• Unsolicited and Severe Adverse Events

  42 days

• Number of Asthma Exacerbations Requiring Steroids

  42 days

• Number Participants With Asthma Exacerbations Requiring Medical Attention

  42 days

Study Arms (2)

IIV4

ACTIVE COMPARATOR

0.5 mL intramuscular injection

Drug: IIV4

cc IIV4

ACTIVE COMPARATOR

0.5 mL intramuscular injection

Drug: ccIIV4

Interventions

ccIIV4 DRUG

Also known as: Flucelvax

cc IIV4

IIV4 DRUG

Also known as: Fluarix

IIV4

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• 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.
• Parent/legal guardian must provide written informed consent and subject must provide assent as appropriate for age prior to initiation of study procedures and according to local Institutional Review Board (IRB) requirement.
• Parent/legal guardian and subject must be willing and able to comply with planned study procedures and be available for all study visits.
• Children aged 5-8 years must have received at least 2 doses of seasonal trivalent or quadrivalent influenza vaccine prior to the current influenza season. Children 9-11 years must have received at least 1 dose of seasonal trivalent or quadrivalent influenza vaccine prior to the current influenza season.
• Is in good health, other than their asthma, as determined by medical history and targeted physical examination based on medical history.
• English or Spanish literate.
• Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and collection of information.

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 (temporary deferral).
• History of a severe allergic reaction (e.g., anaphylaxis) to any component of study influenza vaccines or a known allergy to eggs.
• 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 licensed 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.
• Has immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
• Has taken ≥ 20mg/day of prednisone or its equivalent, for 14 days or more within the past 28 days.
• Has know 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).
• History of Guillian-Barre syndrome within 6 weeks of previous influenza vaccination.
• Has 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 any diagnosis, current or past, of schizophrenia, bipolar disease, or other major psychiatric disorder.
• 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 (4)

Centers for Disease Control and Prevention

Atlanta, Georgia, 30329, United States

Location

Duke Clinical Vaccine Unit

Durham, North Carolina, 27705, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Vanderbilt Vaccine Research Program

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Influenza Vaccines; fluarix

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Kathryn M. Edwards MD
• Organization: Vanderbilt University Medical Center

kathryn.edwards@vanderbilt.edu

615-322-8792

Study Officials

• Kathryn M Edwards, MD

  Vanderbilt Vaccine Research Program

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sarah H. Sell and Cornelius Vanderbilt Professor of Pediatrics

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 18, 2016
• Study Start: October 10, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 23, 2018
• Results First Posted: April 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)