Trial Outcomes & Findings for Safety of LAIV4 in Children With Asthma (NCT NCT03600428)
NCT ID: NCT03600428
Last Updated: 2021-03-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
152 participants
Primary outcome timeframe
Day 43
Results posted on
2021-03-16
Participant Flow
Participant milestones
| Measure |
Live Attenuated Influenza Vaccine (LAIV4)
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
|
Inactivated Influenza Vaccine (IIV4)
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
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
73
|
|
Overall Study
15-day Follow-up
|
76
|
70
|
|
Overall Study
43-day Follow-up
|
74
|
68
|
|
Overall Study
COMPLETED
|
74
|
68
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Live Attenuated Influenza Vaccine (LAIV4)
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
|
Inactivated Influenza Vaccine (IIV4)
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
|
|---|---|---|
|
Overall Study
Not eligible
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
Baseline Characteristics
Safety of LAIV4 in Children With Asthma
Baseline characteristics by cohort
| Measure |
Live Attenuated Influenza Vaccine (LAIV4)
n=79 Participants
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
|
Inactivated Influenza Vaccine (IIV4)
n=72 Participants
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
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.00 years
n=5 Participants
|
9.00 years
n=7 Participants
|
9.00 years
n=5 Participants
|
|
Age, Customized
Age Group · 5-11 years old
|
58 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Age, Customized
Age Group · 12-17 years old
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
144 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 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
|
|
Race/Ethnicity, Customized
Race recoded · White
|
43 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race recoded · Black
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race recoded · Other
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Site
Vanderbilt
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Site
Cincinnati
|
54 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Site
Duke
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Asthma Severity Status
Mild
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Asthma Severity Status
Moderate or Severe
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Weight in kg
|
39.1 kilograms
n=5 Participants
|
35.0 kilograms
n=7 Participants
|
38.3 kilograms
n=5 Participants
|
|
Height
|
53.90 inches
n=5 Participants
|
53.70 inches
n=7 Participants
|
53.75 inches
n=5 Participants
|
|
BMI
|
19.50 kg/m2
n=5 Participants
|
18.60 kg/m2
n=7 Participants
|
18.75 kg/m2
n=5 Participants
|
|
Received seasonal influenza vaccine in the past 12 months
No
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Received seasonal influenza vaccine in the past 12 months
Yes
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Received seasonal influenza vaccine in the past 12 months
Unknown
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
History of nasal or sinus allergies
No
|
19 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
History of nasal or sinus allergies
Yes
|
56 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
History of nasal or sinus allergies
Unknown
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Influenza Season
2018-2019
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Influenza Season
2019-2020
|
52 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 43For 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.
Outcome measures
| Measure |
Live Attenuated Influenza Vaccine (LAIV4)
n=74 Participants
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
|
Inactivated Influenza Vaccine (IIV4)
n=68 Participants
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
|
|---|---|---|
|
Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 42 Days After LAIV4 vs. IIV4 (Until Day 43).
Asthma exacerbation within 43 days
|
8 Participants
|
10 Participants
|
|
Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 42 Days After LAIV4 vs. IIV4 (Until Day 43).
No asthma exacerbation within 43 days
|
66 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: Day 15For 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.
Outcome measures
| Measure |
Live Attenuated Influenza Vaccine (LAIV4)
n=76 Participants
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
|
Inactivated Influenza Vaccine (IIV4)
n=70 Participants
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
|
|---|---|---|
|
Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 14 Days After LAIV4 vs. IIV4
Asthma exacerbation within 14 days
|
3 Participants
|
4 Participants
|
|
Comparison of the Proportion of Participants Experiencing an Asthma Exacerbation During the 14 Days After LAIV4 vs. IIV4
No asthma exacerbation within 14 days
|
73 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: Day 15Cough, wheezing, tightness in chest, nighttime awakening and unscheduled albuterol use will all be assessed by parent self-report
Outcome measures
| Measure |
Live Attenuated Influenza Vaccine (LAIV4)
n=76 Participants
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
|
Inactivated Influenza Vaccine (IIV4)
n=70 Participants
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
|
|---|---|---|
|
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).
Asthma symptoms within 14 days · No
|
18 Participants
|
20 Participants
|
|
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).
Asthma symptoms within 14 days · Yes
|
58 Participants
|
50 Participants
|
|
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).
Night-time awakening within 14 days · No
|
55 Participants
|
42 Participants
|
|
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).
Night-time awakening within 14 days · Yes
|
21 Participants
|
28 Participants
|
|
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).
Unscheduled Albuterol use within 14 days · No
|
41 Participants
|
44 Participants
|
|
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).
Unscheduled Albuterol use within 14 days · Yes
|
35 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Day 15Cough, wheezing, tightness in chest, nighttime awakening and unscheduled albuterol use will all be assessed by parent self-report
Outcome measures
| Measure |
Live Attenuated Influenza Vaccine (LAIV4)
n=76 Participants
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
|
Inactivated Influenza Vaccine (IIV4)
n=70 Participants
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
|
|---|---|---|
|
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).
Asthma related cough within 14 days · None
|
26 Participants
|
22 Participants
|
|
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).
Asthma related cough within 14 days · Mild
|
35 Participants
|
29 Participants
|
|
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).
Asthma related cough within 14 days · Moderate
|
14 Participants
|
15 Participants
|
|
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).
Asthma related cough within 14 days · Severe
|
1 Participants
|
4 Participants
|
|
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).
Asthma related wheezing within 14 days · None
|
51 Participants
|
39 Participants
|
|
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).
Asthma related wheezing within 14 days · Mild
|
19 Participants
|
18 Participants
|
|
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).
Asthma related wheezing within 14 days · Moderate
|
5 Participants
|
12 Participants
|
|
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).
Asthma related wheezing within 14 days · Severe
|
1 Participants
|
1 Participants
|
|
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).
Asthma related chest tightness within 14 days · None
|
58 Participants
|
45 Participants
|
|
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).
Asthma related chest tightness within 14 days · Mild
|
12 Participants
|
21 Participants
|
|
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).
Asthma related chest tightness within 14 days · Moderate
|
5 Participants
|
3 Participants
|
|
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).
Asthma related chest tightness within 14 days · Severe
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 15For purposes of this measure, a clinically significant decrease in peak flow is defined as: a decrease of ≥20% in PEFR from baseline PEFR
Outcome measures
| Measure |
Live Attenuated Influenza Vaccine (LAIV4)
n=76 Participants
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
|
Inactivated Influenza Vaccine (IIV4)
n=70 Participants
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
|
|---|---|---|
|
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
No PEFR decrease >= 20% from baseline within 14 days
|
36 Participants
|
37 Participants
|
|
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
PEFR decreased >= 20% from baseline within 14 days
|
39 Participants
|
33 Participants
|
|
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
Unknown
|
1 Participants
|
0 Participants
|
Adverse Events
Live Attenuated Influenza Vaccine (LAIV4)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Inactivated Influenza Vaccine (IIV4)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Live Attenuated Influenza Vaccine (LAIV4)
n=74 participants at risk
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
|
Inactivated Influenza Vaccine (IIV4)
n=68 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation
|
10.8%
8/74 • Within 42 days (until day 43) after vaccination.
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.
|
14.7%
10/68 • Within 42 days (until day 43) after vaccination.
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.
|
Additional Information
C. Buddy Creech, MD, MPH
Vanderbilt University Medical Center
Phone: 6153430332
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60