Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety of LAIV4 in Children With 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: NCT03600428
Recruitment Status : Completed
First Posted : July 26, 2018
Results First Posted : February 25, 2021
Last Update Posted : March 16, 2021
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Duke University
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Buddy Creech, Vanderbilt University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Asthma in Children
Vaccine Adverse Reaction
Vaccine Reaction
Asthma
Wheezing
Influenza
Interventions Biological: Live Attenuated Influenza Vaccine (LAIV)
Biological: Inactivated Influenza Vaccine (IIV)
Enrollment 152
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Live Attenuated Influenza Vaccine (LAIV4) Inactivated Influenza Vaccine (IIV4)
Hide Arm/Group Description

Participants will receive one dose of quadrivalent 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)).

Quadrivalent Live Attenuated Influenza Vaccine (LAIV4): 1 dose, 0.2 mL, intranasal administration

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

Quadrivalent Inactivated Influenza Vaccine (IIV4): 1 dose, 0.5 mL, intramuscular administration

Period Title: Overall Study
Started 79 73
15-day Follow-up 76 70
43-day Follow-up 74 68
Completed 74 68
Not Completed 5 5
Reason Not Completed
Not eligible             0             1
Lost to Follow-up             5             4
Arm/Group Title Live Attenuated Influenza Vaccine (LAIV4) Inactivated Influenza Vaccine (IIV4) Total
Hide Arm/Group Description

Participants will receive one dose of quadrivalent 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)).

Quadrivalent Live Attenuated Influenza Vaccine (LAIV4): 1 dose, 0.2 mL, intranasal administration

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

Quadrivalent Inactivated Influenza Vaccine (IIV4): 1 dose, 0.5 mL, intramuscular administration

Total of all reporting groups
Overall Number of Baseline Participants 79 72 151
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 79 participants 72 participants 151 participants
9.00
(7.00 to 12.00)
9.00
(7.00 to 11.00)
9.00
(7.00 to 12.00)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Group Number Analyzed 79 participants 72 participants 151 participants
5-11 years old
58
  73.4%
55
  76.4%
113
  74.8%
12-17 years old
21
  26.6%
17
  23.6%
38
  25.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 72 participants 151 participants
Female
35
  44.3%
28
  38.9%
63
  41.7%
Male
44
  55.7%
44
  61.1%
88
  58.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 72 participants 151 participants
Hispanic or Latino
4
   5.1%
3
   4.2%
7
   4.6%
Not Hispanic or Latino
75
  94.9%
69
  95.8%
144
  95.4%
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 79 participants 72 participants 151 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   2.5%
0
   0.0%
2
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
25
  31.6%
24
  33.3%
49
  32.5%
White
43
  54.4%
42
  58.3%
85
  56.3%
More than one race
9
  11.4%
6
   8.3%
15
   9.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race recoded Number Analyzed 79 participants 72 participants 151 participants
White
43
  54.4%
42
  58.3%
85
  56.3%
Black
25
  31.6%
24
  33.3%
49
  32.5%
Other
11
  13.9%
6
   8.3%
17
  11.3%
Site  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 72 participants 151 participants
Vanderbilt
12
  15.2%
8
  11.1%
20
  13.2%
Cincinnati
54
  68.4%
53
  73.6%
107
  70.9%
Duke
13
  16.5%
11
  15.3%
24
  15.9%
Asthma Severity Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 72 participants 151 participants
Mild
26
  32.9%
19
  26.4%
45
  29.8%
Moderate or Severe
53
  67.1%
53
  73.6%
106
  70.2%
Weight in kg  
Median (Inter-Quartile Range)
Unit of measure:  Kilograms
Number Analyzed 79 participants 72 participants 151 participants
39.1
(27.4 to 50.0)
35.0
(24.9 to 52.6)
38.3
(25.7 to 51.4)
Height  
Median (Inter-Quartile Range)
Unit of measure:  Inches
Number Analyzed 79 participants 72 participants 151 participants
53.90
(49.65 to 60.10)
53.70
(49.21 to 60.95)
53.75
(49.46 to 60.15)
BMI  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m2
Number Analyzed 79 participants 72 participants 151 participants
19.50
(16.45 to 22.90)
18.60
(16.15 to 21.65)
18.75
(16.30 to 22.50)
Received seasonal influenza vaccine in the past 12 months  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 72 participants 151 participants
No
42
  53.2%
43
  59.7%
85
  56.3%
Yes
30
  38.0%
26
  36.1%
56
  37.1%
Unknown
7
   8.9%
3
   4.2%
10
   6.6%
History of nasal or sinus allergies  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 72 participants 151 participants
No
19
  24.1%
27
  37.5%
46
  30.5%
Yes
56
  70.9%
45
  62.5%
101
  66.9%
Unknown
4
   5.1%
0
   0.0%
4
   2.6%
Influenza Season  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 72 participants 151 participants
2018-2019
27
  34.2%
25
  34.7%
52
  34.4%
2019-2020
52
  65.8%
47
  65.3%
99
  65.6%
1.Primary Outcome
Title Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 42 Days After LAIV4 vs. IIV4 (Until Day 43).
Hide Description 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.
Time Frame Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Live Attenuated Influenza Vaccine (LAIV4) Inactivated Influenza Vaccine (IIV4)
Hide Arm/Group Description:

Participants received one dose of quadrivalent 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)).

Quadrivalent Live Attenuated Influenza Vaccine (LAIV4): 1 dose, 0.2 mL, intranasal administration

Participants received one dose of quadrivalent inactivated influenza vaccine via intramuscular injection (0.5 mL).

Quadrivalent Inactivated Influenza Vaccine (IIV4): 1 dose, 0.5 mL, intramuscular administration

Overall Number of Participants Analyzed 74 68
Measure Type: Count of Participants
Unit of Measure: Participants
Asthma exacerbation within 43 days
8
  10.8%
10
  14.7%
No asthma exacerbation within 43 days
66
  89.2%
58
  85.3%
2.Secondary Outcome
Title Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 14 Days After LAIV4 vs. IIV4
Hide Description 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 14 days (until day 15) 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.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Live Attenuated Influenza Vaccine (LAIV4) Inactivated Influenza Vaccine (IIV4)
Hide Arm/Group Description:

Participants received one dose of quadrivalent 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)).

Quadrivalent Live Attenuated Influenza Vaccine (LAIV4): 1 dose, 0.2 mL, intranasal administration

Participants received one dose of quadrivalent inactivated influenza vaccine via intramuscular injection (0.5 mL).

Quadrivalent Inactivated Influenza Vaccine (IIV4): 1 dose, 0.5 mL, intramuscular administration

Overall Number of Participants Analyzed 76 70
Measure Type: Count of Participants
Unit of Measure: Participants
Asthma exacerbation within 14 days
3
   3.9%
4
   5.7%
No asthma exacerbation within 14 days
73
  96.1%
66
  94.3%
3.Secondary Outcome
Title 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).
Hide Description Cough, wheezing, tightness in chest, nighttime awakening and unscheduled albuterol use will all be assessed by parent self-report
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Live Attenuated Influenza Vaccine (LAIV4) Inactivated Influenza Vaccine (IIV4)
Hide Arm/Group Description:

Participants received one dose of quadrivalent 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)).

Quadrivalent Live Attenuated Influenza Vaccine (LAIV4): 1 dose, 0.2 mL, intranasal administration

Participants received one dose of quadrivalent inactivated influenza vaccine via intramuscular injection (0.5 mL).

Quadrivalent Inactivated Influenza Vaccine (IIV4): 1 dose, 0.5 mL, intramuscular administration

Overall Number of Participants Analyzed 76 70
Measure Type: Count of Participants
Unit of Measure: Participants
Asthma symptoms within 14 days No
18
  23.7%
20
  28.6%
Yes
58
  76.3%
50
  71.4%
Night-time awakening within 14 days No
55
  72.4%
42
  60.0%
Yes
21
  27.6%
28
  40.0%
Unscheduled Albuterol use within 14 days No
41
  53.9%
44
  62.9%
Yes
35
  46.1%
26
  37.1%
4.Secondary Outcome
Title 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).
Hide Description Cough, wheezing, tightness in chest, nighttime awakening and unscheduled albuterol use will all be assessed by parent self-report
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Live Attenuated Influenza Vaccine (LAIV4) Inactivated Influenza Vaccine (IIV4)
Hide Arm/Group Description:

Participants received one dose of quadrivalent 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)).

Quadrivalent Live Attenuated Influenza Vaccine (LAIV4): 1 dose, 0.2 mL, intranasal administration

Participants received one dose of quadrivalent inactivated influenza vaccine via intramuscular injection (0.5 mL).

Quadrivalent Inactivated Influenza Vaccine (IIV4): 1 dose, 0.5 mL, intramuscular administration

Overall Number of Participants Analyzed 76 70
Measure Type: Count of Participants
Unit of Measure: Participants
Asthma related cough within 14 days None
26
  34.2%
22
  31.4%
Mild
35
  46.1%
29
  41.4%
Moderate
14
  18.4%
15
  21.4%
Severe
1
   1.3%
4
   5.7%
Asthma related wheezing within 14 days None
51
  67.1%
39
  55.7%
Mild
19
  25.0%
18
  25.7%
Moderate
5
   6.6%
12
  17.1%
Severe
1
   1.3%
1
   1.4%
Asthma related chest tightness within 14 days None
58
  76.3%
45
  64.3%
Mild
12
  15.8%
21
  30.0%
Moderate
5
   6.6%
3
   4.3%
Severe
1
   1.3%
1
   1.4%
5.Secondary Outcome
Title 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
Hide Description For purposes of this measure, a clinically significant decrease in peak flow is defined as: a decrease of ≥20% in PEFR from baseline PEFR
Time Frame Baseline, Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Live Attenuated Influenza Vaccine (LAIV4) Inactivated Influenza Vaccine (IIV4)
Hide Arm/Group Description:

Participants received one dose of quadrivalent 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)).

Quadrivalent Live Attenuated Influenza Vaccine (LAIV4): 1 dose, 0.2 mL, intranasal administration

Participants received one dose of quadrivalent inactivated influenza vaccine via intramuscular injection (0.5 mL).

Quadrivalent Inactivated Influenza Vaccine (IIV4): 1 dose, 0.5 mL, intramuscular administration

Overall Number of Participants Analyzed 76 70
Measure Type: Count of Participants
Unit of Measure: Participants
No PEFR decrease >= 20% from baseline within 14 days
36
  47.4%
37
  52.9%
PEFR decreased >= 20% from baseline within 14 days
39
  51.3%
33
  47.1%
Unknown
1
   1.3%
0
   0.0%
Time Frame Within 42 days (until day 43) after vaccination.
Adverse Event Reporting Description Adverse events (AEs), including serious adverse events (SAEs) were recorded on the memory aid and included the need for new prescription or nonprescription medications for the control of asthma, an unscheduled healthcare provider visit or consultation, any other clinically significant event at any point during the study period. The definition of SAEs matched the definition from clinicaltrials.gov.
 
Arm/Group Title Live Attenuated Influenza Vaccine (LAIV4) Inactivated Influenza Vaccine (IIV4)
Hide Arm/Group Description

Participants received one dose of quadrivalent 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)).

Quadrivalent Live Attenuated Influenza Vaccine (LAIV4): 1 dose, 0.2 mL, intranasal administration

Participants received one dose of quadrivalent inactivated influenza vaccine via intramuscular injection (0.5 mL).

Quadrivalent Inactivated Influenza Vaccine (IIV4): 1 dose, 0.5 mL, intramuscular administration

All-Cause Mortality
Live Attenuated Influenza Vaccine (LAIV4) Inactivated Influenza Vaccine (IIV4)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/74 (0.00%)   0/68 (0.00%) 
Hide Serious Adverse Events
Live Attenuated Influenza Vaccine (LAIV4) Inactivated Influenza Vaccine (IIV4)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/74 (0.00%)   0/68 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Live Attenuated Influenza Vaccine (LAIV4) Inactivated Influenza Vaccine (IIV4)
Affected / at Risk (%) Affected / at Risk (%)
Total   8/74 (10.81%)   10/68 (14.71%) 
Respiratory, thoracic and mediastinal disorders     
Asthma Exacerbation  [1]  8/74 (10.81%)  10/68 (14.71%) 
Indicates events were collected by systematic assessment
[1]
Any acute episode of progressively worsening shortness of breath, cough, wheezing, chest tightness, and/or respiratory distress for which the patient seeks unscheduled medical attention or receives a new prescription for systemic corticosteroids.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: C. Buddy Creech, MD, MPH
Organization: Vanderbilt University Medical Center
Phone: 6153430332
EMail: buddy.creech@vumc.org
Layout table for additonal information
Responsible Party: Buddy Creech, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03600428    
Other Study ID Numbers: 181211
200-2012-50430 Task Order 0005 ( Other Grant/Funding Number: Centers for Disease Control and Prevention )
First Submitted: July 11, 2018
First Posted: July 26, 2018
Results First Submitted: February 5, 2021
Results First Posted: February 25, 2021
Last Update Posted: March 16, 2021