Influenza Vaccine Feasibility Study in Children With Persistent Asthma

• ClinicalTrials.gov Identifier: NCT02967393
• Recruitment Status: Completed
• First Posted: November 18, 2016
• Results First Posted: April 23, 2018
• Last Update Posted: April 23, 2018
• Sponsor: Vanderbilt University Medical Center
• Collaborators: Centers for Disease Control and Prevention; Duke University; Children's Hospital Medical Center, Cincinnati
• Information provided by (Responsible Party): Kathryn Edwards, Vanderbilt University Medical Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Asthmatic
• Interventions: Drug: ccIIV4; Drug: IIV4
• Enrollment: 40

Participant Flow

Recruitment Details
Pre-assignment Details	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.

Arm/Group Title	ccIIV4	IIV4
Arm/Group Description	0.5 mL intramuscular injection ccIIV4	0.5 mL intramuscular injection IIV4
Period Title: Overall Study
Started	20	20
Completed	20	20
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		ccIIV4	IIV4	Total
Arm/Group Description		0.5 mL intramuscular injection ccIIV4	0.5 mL intramuscular injection IIV4	Total of all reporting groups
Overall Number of Baseline Participants		20	20	40
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	20 participants	40 participants
	<=18 years	20 100.0%	20 100.0%	40 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	20 participants	40 participants
	Female	6 30.0%	10 50.0%	16 40.0%
	Male	14 70.0%	10 50.0%	24 60.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	20 participants	40 participants
	Hispanic or Latino	0 0.0%	4 20.0%	4 10.0%
	Not Hispanic or Latino	20 100.0%	16 80.0%	36 90.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	20 participants	40 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	9 45.0%	6 30.0%	15 37.5%
	White	9 45.0%	9 45.0%	18 45.0%
	More than one race	2 10.0%	5 25.0%	7 17.5%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	20 participants	20 participants	40 participants
		20 100.0%	20 100.0%	40 100.0%

Outcome Measures

1. Primary Outcome

Title	Feasibility Benchmark: Number of Parents That Complete the Memory Aid 1.
Description	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.
Time Frame	15 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Parents
Arm/Group Description:	Parents of participants from both arms
Overall Number of Participants Analyzed	40
Measure Type: Count of Participants; Unit of Measure: Participants
	35 87.5%

2. Primary Outcome

Title	Feasibility Benchmark: Number of Parent Completing Collection of Adverse Event Data
Description	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.
Time Frame	Day 16 to 43

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Participants
Arm/Group Description:	Participants from both arms
Overall Number of Participants Analyzed	40
Measure Type: Count of Participants; Unit of Measure: Participants
	37 92.5%

3. Primary Outcome

Title	Feasibility Benchmark: Number of Parents That Perform and Document All Home Digital Peak Flow Measurements
Description	Number of parents that perform and document all home digital peak flow measurements at least 11 days out of the 15-day monitoring period.
Time Frame	15 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Participants
Arm/Group Description:	Participants from both arms
Overall Number of Participants Analyzed	40
Measure Type: Count of Participants; Unit of Measure: Participants
	37 92.5%

4. Primary Outcome

Title	Feasibility Benchmark: Number of Parents That Perform and Document the Digital Peak Flow for Day 42
Description	Parent will perform and document the digital peak flow for Day 42
Time Frame	Day 42

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Participants
Arm/Group Description:	Participants from both arms
Overall Number of Participants Analyzed	40
Measure Type: Count of Participants; Unit of Measure: Participants
	37 92.5%

5. Primary Outcome

Title	Feasibility Benchmark: Number of Parents That Document Nighttime Awakenings
Description	Number of parents that document nighttime awakenings for at least 11 of the 15-day monitoring period.
Time Frame	15 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Participants
Arm/Group Description:	Participants from both arms
Overall Number of Participants Analyzed	40
Measure Type: Count of Participants; Unit of Measure: Participants
	37 92.5%

6. Primary Outcome

Title	Feasibility Benchmark: Number of Parents That Respond to Day 4 Call and Provide Requested Data
Description	Number of parents that respond to Day 4 ( -1 day or + 2 days) call and provide requested data
Time Frame	Day 3 to 6

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Participants
Arm/Group Description:	Participants from both arms
Overall Number of Participants Analyzed	40
Measure Type: Count of Participants; Unit of Measure: Participants
	39 97.5%

7. Primary Outcome

Title	Feasibility Benchmark: Number of Parents That Respond to Day 8 Call and Provide Requested Data.
Description	Number of parents that respond to Day 8 (plus 2 days) call and provide requested data.
Time Frame	Day 8-10

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Participants
Arm/Group Description:	Participants from both arms
Overall Number of Participants Analyzed	40
Measure Type: Count of Participants; Unit of Measure: Participants
	39 97.5%

8. Primary Outcome

Title	Feasibility Benchmark: Number of Parents That Respond to Day 15 Call and Provide Requested Data
Description	Number of parents that respond to Day 15 (minus 1 or plus 2 days) call and provide requested data
Time Frame	Day 14 to 17

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Participants
Arm/Group Description:	Participants from both arms
Overall Number of Participants Analyzed	40
Measure Type: Count of Participants; Unit of Measure: Participants
	39 97.5%

9. Primary Outcome

Title	Feasibility Benchmark: Number of Parents That Respond to Day 29 Call and Provide Requested Data.
Description	Number of Parents that respond to Day 29 ( Plus 2 Days) call and provide requested data.
Time Frame	Day 29-31

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Participants
Arm/Group Description:	Participants from both arms
Overall Number of Participants Analyzed	40
Measure Type: Count of Participants; Unit of Measure: Participants
	37 92.5%

10. Primary Outcome

Title	Feasibility Benchmark: Number of Parents That Respond to Day 44 Call
Description	Number of parents that respond to Day 44 ( Plus 3 Days) call and provide requested data.
Time Frame	Day 44-47

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Participants
Arm/Group Description:	Participants from both arms
Overall Number of Participants Analyzed	40
Measure Type: Count of Participants; Unit of Measure: Participants
	36 90.0%

11. Primary Outcome

Title	Feasibility Benchmark: Number of Parents Completing a Satisfaction Survey
Description	Parent of each participant will be asked to complete a at the end of the study
Time Frame	42 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Participants
Arm/Group Description:	Participants from both arms
Overall Number of Participants Analyzed	40
Measure Type: Count of Participants; Unit of Measure: Participants
	36 90.0%

12. Secondary Outcome

Title	Severe Local Reactogenicity Events During the 14 Days Post-vaccination
Description	Number of severe local reactogenicity events for 14 days after vaccination between recipients of ccIIV4 and IIV4.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ccIIV4	IIV4
Arm/Group Description:	0.5 mL intramuscular injection ccIIV4	0.5 mL intramuscular injection IIV4
Overall Number of Participants Analyzed	20	20
Measure Type: Number; Unit of Measure: number of events
	0	2

13. Secondary Outcome

Title	Severe Systemic Reactogenicity Events During the 14 Days Post-vaccination
Description	Number of solicited severe (not serious) systemic reactogenicity events for 14 days after vaccination between recipients of ccIIV4 and IIV4.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ccIIV4	IIV4
Arm/Group Description:	0.5 mL intramuscular injection ccIIV4	0.5 mL intramuscular injection IIV4
Overall Number of Participants Analyzed	20	20
Measure Type: Number; Unit of Measure: number of events
	1	1

14. Secondary Outcome

Title	Unsolicited and Severe Adverse Events
Description	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.
Time Frame	42 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ccIIV4	IIV4
Arm/Group Description:	0.5 mL intramuscular injection ccIIV4	0.5 mL intramuscular injection IIV4
Overall Number of Participants Analyzed	20	20
Measure Type: Number; Unit of Measure: number of events
wheezing	1	0
hand foot and mouth virus	1	0

15. Secondary Outcome

Title	Number of Asthma Exacerbations Requiring Steroids
Description	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..
Time Frame	42 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ccIIV4	IIV4
Arm/Group Description:	0.5 mL intramuscular injection ccIIV4	0.5 mL intramuscular injection IIV4
Overall Number of Participants Analyzed	20	20
Measure Type: Number; Unit of Measure: number of events
	3	1

16. Secondary Outcome

Title	Number Participants With Asthma Exacerbations Requiring Medical Attention
Description	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)
Time Frame	42 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ccIIV4	IIV4
Arm/Group Description:	0.5 mL intramuscular injection ccIIV4	0.5 mL intramuscular injection IIV4
Overall Number of Participants Analyzed	20	20
Measure Type: Count of Participants; Unit of Measure: Participants
	6 30.0%	4 20.0%

Adverse Events

Time Frame	42 days from vaccination
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	ccIIV4		IIV4
Arm/Group Description	0.5 mL intramuscular injection ccIIV4		0.5 mL intramuscular injection IIV4
All-Cause Mortality
	ccIIV4		IIV4
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/20 (0.00%)		0/20 (0.00%)
Serious Adverse Events
	ccIIV4		IIV4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5.00%)		0/20 (0.00%)
Respiratory, thoracic and mediastinal disorders
Wheezing †	1/20 (5.00%)	1	0/20 (0.00%)	0
Skin and subcutaneous tissue disorders
Hand foot and mouth disease †	1/20 (5.00%)	1	0/20 (0.00%)	0
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	ccIIV4		IIV4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/20 (95.00%)		19/20 (95.00%)
Gastrointestinal disorders
Stomache Ache †	6/20 (30.00%)	6	7/20 (35.00%)	7
Vomiting †	0/20 (0.00%)	0	3/20 (15.00%)	3
General disorders
Headache †	7/20 (35.00%)	7	7/20 (35.00%)	7
Muscles Aches †	2/20 (10.00%)	2	5/20 (25.00%)	5
Bone Pain †	2/20 (10.00%)	2	4/20 (20.00%)	4
Fatigue †	6/20 (30.00%)	6	12/20 (60.00%)	12
Decrease Appetite †	4/20 (20.00%)	4	8/20 (40.00%)	8
Irritability †	7/20 (35.00%)	7	11/20 (55.00%)	11
Immune system disorders
Local Reaction to Vaccine † [1]	19/20 (95.00%)	19	19/20 (95.00%)	19
Feverish †	4/20 (20.00%)	4	5/20 (25.00%)	5
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbations †	6/20 (30.00%)	6	4/20 (20.00%)	4
† Indicates events were collected by systematic assessment; [1] includes mild, moderate and severe local reactions

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Kathryn M. Edwards MD
• Organization: Vanderbilt University Medical Center
• Phone: 615-322-8792
• EMail: kathryn.edwards@vanderbilt.edu

• Responsible Party: Kathryn Edwards, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT02967393
• Other Study ID Numbers: IIV4/LAIV4/CDC
• First Submitted: October 31, 2016
• First Posted: November 18, 2016
• Results First Submitted: January 9, 2018
• Results First Posted: April 23, 2018
• Last Update Posted: April 23, 2018