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Influenza Vaccine Feasibility Study in Children With Persistent Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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
Hide 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
Arm/Group Title ccIIV4 IIV4 Total
Hide 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
Hide 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%
1.Primary Outcome
Title Feasibility Benchmark: Number of Parents That Complete the Memory Aid 1.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Parent will perform and document the digital peak flow for Day 42
Time Frame Day 42
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Number of parents that document nighttime awakenings for at least 11 of the 15-day monitoring period.
Time Frame 15 days
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide Description Number of parents that respond to Day 8 (plus 2 days) call and provide requested data.
Time Frame Day 8-10
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Hide Description Number of Parents that respond to Day 29 ( Plus 2 Days) call and provide requested data.
Time Frame Day 29-31
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Number of parents that respond to Day 44 ( Plus 3 Days) call and provide requested data.
Time Frame Day 44-47
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Parent of each participant will be asked to complete a at the end of the study
Time Frame 42 days
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Number of severe local reactogenicity events for 14 days after vaccination between recipients of ccIIV4 and IIV4.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ccIIV4 IIV4
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ccIIV4 IIV4
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ccIIV4 IIV4
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ccIIV4 IIV4
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ccIIV4 IIV4
Hide 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%
Time Frame 42 days from vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ccIIV4 IIV4
Hide 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%)    
Hide 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
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Kathryn M. Edwards MD
Organization: Vanderbilt University Medical Center
Phone: 615-322-8792
EMail: kathryn.edwards@vanderbilt.edu
Layout table for additonal information
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