Trial Outcomes & Findings for Influenza Vaccine Feasibility Study in Children With Persistent Asthma (NCT NCT02967393)

NCT ID: NCT02967393

Last Updated: 2018-04-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: 15 days
• Results posted on: 2018-04-23

Participant Flow

Feasibility Measures are done by the parent/guardian of the participants. Feasibility Measure data will be reported as a single group. Participant data (vaccine data) will be reported by the type of vaccination received.

Participant milestones

Measure	ccIIV4 0.5 mL intramuscular injection ccIIV4	IIV4 0.5 mL intramuscular injection IIV4
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Influenza Vaccine Feasibility Study in Children With Persistent Asthma

Baseline characteristics by cohort

Measure	ccIIV4 n=20 Participants 0.5 mL intramuscular injection ccIIV4	IIV4 n=20 Participants 0.5 mL intramuscular injection IIV4	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 days

Population: Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.

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.

Outcome measures

Measure	All Parents n=40 Participants Parents of participants from both arms	IIV4 0.5 mL intramuscular injection IIV4
Feasibility Benchmark: Number of Parents That Complete the Memory Aid 1.	35 Participants	—

PRIMARY outcome

Timeframe: Day 16 to 43

Population: Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.

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.

Outcome measures

Measure	All Parents n=40 Participants Parents of participants from both arms	IIV4 0.5 mL intramuscular injection IIV4
Feasibility Benchmark: Number of Parent Completing Collection of Adverse Event Data	37 Participants	—

PRIMARY outcome

Timeframe: 15 days

Population: Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.

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

Outcome measures

Measure	All Parents n=40 Participants Parents of participants from both arms	IIV4 0.5 mL intramuscular injection IIV4
Feasibility Benchmark: Number of Parents That Perform and Document All Home Digital Peak Flow Measurements	37 Participants	—

PRIMARY outcome

Timeframe: Day 42

Population: Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received.. Feasibility Measure data will be reported as a single group.

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

Outcome measures

Measure	All Parents n=40 Participants Parents of participants from both arms	IIV4 0.5 mL intramuscular injection IIV4
Feasibility Benchmark: Number of Parents That Perform and Document the Digital Peak Flow for Day 42	37 Participants	—

PRIMARY outcome

Timeframe: 15 days

Population: Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.

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

Outcome measures

Measure	All Parents n=40 Participants Parents of participants from both arms	IIV4 0.5 mL intramuscular injection IIV4
Feasibility Benchmark: Number of Parents That Document Nighttime Awakenings	37 Participants	—

PRIMARY outcome

Timeframe: Day 3 to 6

Population: Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.

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

Outcome measures

Measure	All Parents n=40 Participants Parents of participants from both arms	IIV4 0.5 mL intramuscular injection IIV4
Feasibility Benchmark: Number of Parents That Respond to Day 4 Call and Provide Requested Data	39 Participants	—

PRIMARY outcome

Timeframe: Day 8-10

Population: Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.

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

Outcome measures

Measure	All Parents n=40 Participants Parents of participants from both arms	IIV4 0.5 mL intramuscular injection IIV4
Feasibility Benchmark: Number of Parents That Respond to Day 8 Call and Provide Requested Data.	39 Participants	—

PRIMARY outcome

Timeframe: Day 14 to 17

Population: Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.

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

Outcome measures

Measure	All Parents n=40 Participants Parents of participants from both arms	IIV4 0.5 mL intramuscular injection IIV4
Feasibility Benchmark: Number of Parents That Respond to Day 15 Call and Provide Requested Data	39 Participants	—

PRIMARY outcome

Timeframe: Day 29-31

Population: Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.

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

Outcome measures

Measure	All Parents n=40 Participants Parents of participants from both arms	IIV4 0.5 mL intramuscular injection IIV4
Feasibility Benchmark: Number of Parents That Respond to Day 29 Call and Provide Requested Data.	37 Participants	—

PRIMARY outcome

Timeframe: Day 44-47

Population: Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.

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

Outcome measures

Measure	All Parents n=40 Participants Parents of participants from both arms	IIV4 0.5 mL intramuscular injection IIV4
Feasibility Benchmark: Number of Parents That Respond to Day 44 Call	36 Participants	—

PRIMARY outcome

Timeframe: 42 days

Population: Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.

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

Outcome measures

Measure	All Parents n=40 Participants Parents of participants from both arms	IIV4 0.5 mL intramuscular injection IIV4
Feasibility Benchmark: Number of Parents Completing a Satisfaction Survey	36 Participants	—

SECONDARY outcome

Timeframe: 14 days

Number of severe local reactogenicity events for 14 days after vaccination between recipients of ccIIV4 and IIV4.

Outcome measures

Measure	All Parents n=20 Participants Parents of participants from both arms	IIV4 n=20 Participants 0.5 mL intramuscular injection IIV4
Severe Local Reactogenicity Events During the 14 Days Post-vaccination	0 number of events	2 number of events

SECONDARY outcome

Timeframe: 14 days

Number of solicited severe (not serious) systemic reactogenicity events for 14 days after vaccination between recipients of ccIIV4 and IIV4.

Outcome measures

Measure	All Parents n=20 Participants Parents of participants from both arms	IIV4 n=20 Participants 0.5 mL intramuscular injection IIV4
Severe Systemic Reactogenicity Events During the 14 Days Post-vaccination	1 number of events	1 number of events

SECONDARY outcome

Timeframe: 42 days

The nature and frequency of the unsolicited and Severe adverse events will be described in children receiving ccIIV4 and IIV4 during the 42 days after vaccination.

Outcome measures

Measure	All Parents n=20 Participants Parents of participants from both arms	IIV4 n=20 Participants 0.5 mL intramuscular injection IIV4
Unsolicited and Severe Adverse Events wheezing	1 number of events	0 number of events
Unsolicited and Severe Adverse Events hand foot and mouth virus	1 number of events	0 number of events

SECONDARY outcome

Timeframe: 42 days

For the purpose of 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 post-vaccination (until day 43) for which the patient receives a new prescription for systemic corticosteroids..

Outcome measures

Measure	All Parents n=20 Participants Parents of participants from both arms	IIV4 n=20 Participants 0.5 mL intramuscular injection IIV4
Number of Asthma Exacerbations Requiring Steroids	3 number of events	1 number of events

SECONDARY outcome

Timeframe: 42 days

For the purpose of 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 post-vaccination (until day 43) for which the patient seeks unscheduled medical attention (e.g., healthcare provider office or Emergency Department visit or hospitalization)

Outcome measures

Measure	All Parents n=20 Participants Parents of participants from both arms	IIV4 n=20 Participants 0.5 mL intramuscular injection IIV4
Number Participants With Asthma Exacerbations Requiring Medical Attention	6 Participants	4 Participants

Adverse Events

ccIIV4

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

IIV4

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	ccIIV4 n=20 participants at risk 0.5 mL intramuscular injection ccIIV4	IIV4 n=20 participants at risk 0.5 mL intramuscular injection IIV4
Respiratory, thoracic and mediastinal disorders Wheezing	5.0% 1/20 • Number of events 1 • 42 days from vaccination	0.00% 0/20 • 42 days from vaccination
Skin and subcutaneous tissue disorders Hand foot and mouth disease	5.0% 1/20 • Number of events 1 • 42 days from vaccination	0.00% 0/20 • 42 days from vaccination

Other adverse events

Measure	ccIIV4 n=20 participants at risk 0.5 mL intramuscular injection ccIIV4	IIV4 n=20 participants at risk 0.5 mL intramuscular injection IIV4
Respiratory, thoracic and mediastinal disorders Asthma Exacerbations	30.0% 6/20 • Number of events 6 • 42 days from vaccination	20.0% 4/20 • Number of events 4 • 42 days from vaccination
Immune system disorders Local Reaction to Vaccine	95.0% 19/20 • Number of events 19 • 42 days from vaccination	95.0% 19/20 • Number of events 19 • 42 days from vaccination
Immune system disorders Feverish	20.0% 4/20 • Number of events 4 • 42 days from vaccination	25.0% 5/20 • Number of events 5 • 42 days from vaccination
General disorders Headache	35.0% 7/20 • Number of events 7 • 42 days from vaccination	35.0% 7/20 • Number of events 7 • 42 days from vaccination
General disorders Muscles Aches	10.0% 2/20 • Number of events 2 • 42 days from vaccination	25.0% 5/20 • Number of events 5 • 42 days from vaccination
General disorders Bone Pain	10.0% 2/20 • Number of events 2 • 42 days from vaccination	20.0% 4/20 • Number of events 4 • 42 days from vaccination
General disorders Fatigue	30.0% 6/20 • Number of events 6 • 42 days from vaccination	60.0% 12/20 • Number of events 12 • 42 days from vaccination
General disorders Decrease Appetite	20.0% 4/20 • Number of events 4 • 42 days from vaccination	40.0% 8/20 • Number of events 8 • 42 days from vaccination
Gastrointestinal disorders Stomache Ache	30.0% 6/20 • Number of events 6 • 42 days from vaccination	35.0% 7/20 • Number of events 7 • 42 days from vaccination
Gastrointestinal disorders Vomiting	0.00% 0/20 • 42 days from vaccination	15.0% 3/20 • Number of events 3 • 42 days from vaccination
General disorders Irritability	35.0% 7/20 • Number of events 7 • 42 days from vaccination	55.0% 11/20 • Number of events 11 • 42 days from vaccination

Additional Information

Kathryn M. Edwards MD

Vanderbilt University Medical Center

Phone: 615-322-8792

Email: kathryn.edwards@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place