Trial Outcomes & Findings for Immunologic Response to FluMist vs. Flucelvax (NCT NCT03982069)
NCT ID: NCT03982069
Last Updated: 2021-10-14
Results Overview
Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of \>=10 and a final HI titer of \>=40.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
465 participants
Primary outcome timeframe
Post-vaccination (at Day 28 timepoint)
Results posted on
2021-10-14
Participant Flow
Participant milestones
| Measure |
FluMist Live Attenuated Influenza Vaccine 2019
Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally
FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
|
Flucelvax Inactivated Influenza Vaccine 2019
Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
|
FluMist Live Attenuated Influenza Vaccine 2020
Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally
FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
|
Flucelvax Inactivated Influenza Vaccine 2020
Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
108
|
110
|
127
|
120
|
|
Overall Study
COMPLETED
|
98
|
100
|
118
|
112
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
9
|
8
|
Reasons for withdrawal
| Measure |
FluMist Live Attenuated Influenza Vaccine 2019
Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally
FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
|
Flucelvax Inactivated Influenza Vaccine 2019
Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
|
FluMist Live Attenuated Influenza Vaccine 2020
Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally
FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
|
Flucelvax Inactivated Influenza Vaccine 2020
Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
3
|
5
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
5
|
2
|
|
Overall Study
Specimen loss
|
3
|
3
|
1
|
1
|
Baseline Characteristics
Immunologic Response to FluMist vs. Flucelvax
Baseline characteristics by cohort
| Measure |
FluMist Live Attenuated Influenza Vaccine 2019
n=108 Participants
Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally
FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
|
Flucelvax Inactivated Influenza Vaccine 2019
n=110 Participants
Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
|
FluMist Live Attenuated Influenza Vaccine 2020
n=127 Participants
Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally
FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
|
Flucelvax Inactivated Influenza Vaccine 2020
n=120 Participants
Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
|
Total
n=465 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
47 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
253 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
212 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
16.8 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
16.6 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
15.6 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
15.1 years
STANDARD_DEVIATION 5.2 • n=4 Participants
|
16.0 years
STANDARD_DEVIATION 4.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
254 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
211 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
439 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
138 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
259 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
108 participants
n=5 Participants
|
110 participants
n=7 Participants
|
127 participants
n=5 Participants
|
120 participants
n=4 Participants
|
465 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Post-vaccination (at Day 28 timepoint)Population: 2019 Participants
Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of \>=10 and a final HI titer of \>=40.
Outcome measures
| Measure |
FluMist Live Attenuated Influenza Vaccine 2019
n=98 Participants
Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally
FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
|
Flucelvax Inactivated Influenza Vaccine 2019
n=100 Participants
Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
|
|---|---|---|
|
Number of Participants With Seroconversion Response In 2019
A/H1N1-A/Brisbane
|
5 Participants
|
33 Participants
|
|
Number of Participants With Seroconversion Response In 2019
A/H3N2-A/Kansas egg grown virus
|
11 Participants
|
44 Participants
|
|
Number of Participants With Seroconversion Response In 2019
A/H3N2-A/Kansas cell grown virus
|
8 Participants
|
47 Participants
|
|
Number of Participants With Seroconversion Response In 2019
B/Victoria-B/Colorado
|
9 Participants
|
28 Participants
|
|
Number of Participants With Seroconversion Response In 2019
B/Yamagata-B/Phuket
|
4 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: Post-vaccination (at Day 28 timepoint)Population: 2020 Participants
Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of \>=10 and a final HI titer of \>=40.
Outcome measures
| Measure |
FluMist Live Attenuated Influenza Vaccine 2019
n=118 Participants
Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally
FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
|
Flucelvax Inactivated Influenza Vaccine 2019
n=112 Participants
Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
|
|---|---|---|
|
Number of Participants With Seroconversion Response In 2020
A/H1N1-A/Hawaii66 egg based antigen
|
8 Participants
|
59 Participants
|
|
Number of Participants With Seroconversion Response In 2020
A/H1N1-A/Hawaii70 cell based antigen
|
10 Participants
|
58 Participants
|
|
Number of Participants With Seroconversion Response In 2020
A/H1N1-A/Delaware
|
2 Participants
|
38 Participants
|
|
Number of Participants With Seroconversion Response In 2020
A/H3N2-A/Hong Kong
|
14 Participants
|
48 Participants
|
|
Number of Participants With Seroconversion Response In 2020
B/Victoria-B/Washington
|
13 Participants
|
36 Participants
|
|
Number of Participants With Seroconversion Response In 2020
B/Yamagata-B/Phuket
|
11 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)Population: 2019 Participants
Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroprotection is defined as a HI titer \>= 1:110 at either time point.
Outcome measures
| Measure |
FluMist Live Attenuated Influenza Vaccine 2019
n=98 Participants
Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally
FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
|
Flucelvax Inactivated Influenza Vaccine 2019
n=100 Participants
Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
|
|---|---|---|
|
Number of Participants With Seroprotection Response in 2019
A/H1N1-A/Birsbane:Day 0
|
54 Participants
|
61 Participants
|
|
Number of Participants With Seroprotection Response in 2019
A/H1N1-A/Birsbane:Day 28
|
58 Participants
|
93 Participants
|
|
Number of Participants With Seroprotection Response in 2019
A/H3N2-AKansas egg grown virus: Day 0
|
34 Participants
|
41 Participants
|
|
Number of Participants With Seroprotection Response in 2019
A/H3N2-AKansas egg grown virus: Day 28
|
41 Participants
|
77 Participants
|
|
Number of Participants With Seroprotection Response in 2019
A/H3N2-AKansas cell grown virus: Day 0
|
14 Participants
|
24 Participants
|
|
Number of Participants With Seroprotection Response in 2019
A/H3N2-AKansas cell grown virus: Day 28
|
26 Participants
|
65 Participants
|
|
Number of Participants With Seroprotection Response in 2019
B/Victoria-B/Colorado: Day 0
|
34 Participants
|
34 Participants
|
|
Number of Participants With Seroprotection Response in 2019
B/Victoria-B/Colorado: Day 28
|
36 Participants
|
71 Participants
|
|
Number of Participants With Seroprotection Response in 2019
B/Yamagata-B/Phuket: Day 0
|
57 Participants
|
51 Participants
|
|
Number of Participants With Seroprotection Response in 2019
B/Yamagata-B/Phuket: Day 28
|
57 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)Population: 2019 Participants
Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition assay was conducted to assess immunologic outcome. GMTs is defined as the anti-log of the mean of the log2 HI titers
Outcome measures
| Measure |
FluMist Live Attenuated Influenza Vaccine 2019
n=98 Participants
Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally
FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
|
Flucelvax Inactivated Influenza Vaccine 2019
n=100 Participants
Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) at Each Time Point 2019
A/H1N1-A/Brisbane: Day 0
|
94 titer
Interval 77.0 to 116.0
|
90 titer
Interval 73.0 to 111.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2019
A/H1N1-A/Brisbane: Day 28
|
108 titer
Interval 89.0 to 132.0
|
269 titer
Interval 228.0 to 317.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2019
A/H3N2-A/Kansas egg grown virus: Day 0
|
75 titer
Interval 64.0 to 89.0
|
78 titer
Interval 66.0 to 95.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2019
A/H3N2-A/Kansas egg grown virus: Day 28
|
96 titer
Interval 83.0 to 112.0
|
205 titer
Interval 178.0 to 237.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2019
A/H3N2-A/Kansas cell grown virus: Day 0
|
50 titer
Interval 43.0 to 58.0
|
46 titer
Interval 38.0 to 55.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2019
A/H3N2-A/Kansas cell grown virus: Day 28
|
63 titer
Interval 58.0 to 74.0
|
136 titer
Interval 113.0 to 165.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2019
B/Victoria-B/Colorado: Day 0
|
65 titer
Interval 53.0 to 81.0
|
65 titer
Interval 53.0 to 79.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2019
B/Victoria-B/Colorado: Day 28
|
78 titer
Interval 64.0 to 94.0
|
158 titer
Interval 134.0 to 186.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2019
B/Yamagata-B/Phuket: Day 0
|
101 titer
Interval 83.0 to 122.0
|
89 titer
Interval 74.0 to 107.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2019
B/Yamagata-B/Phuket: Day 28
|
107 titer
Interval 90.0 to 128.0
|
215 titer
Interval 191.0 to 241.0
|
SECONDARY outcome
Timeframe: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)Population: 2020 Participants
Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroprotection is defined as a HI titer \>= 1:110 at either time point.
Outcome measures
| Measure |
FluMist Live Attenuated Influenza Vaccine 2019
n=118 Participants
Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally
FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
|
Flucelvax Inactivated Influenza Vaccine 2019
n=112 Participants
Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
|
|---|---|---|
|
Number of Participants With Seroprotection Response in 2020
B/Yamagata-B/Phuket: Day 28
|
64 Participants
|
92 Participants
|
|
Number of Participants With Seroprotection Response in 2020
A/H1N1-A/Hawaii66 egg: Day 0
|
25 Participants
|
25 Participants
|
|
Number of Participants With Seroprotection Response in 2020
A/H1N1-A/Hawaii66 egg: Day 28
|
33 Participants
|
79 Participants
|
|
Number of Participants With Seroprotection Response in 2020
A/H1N1-A/Hawaii70 cell grown virus: Day 0
|
59 Participants
|
54 Participants
|
|
Number of Participants With Seroprotection Response in 2020
A/H1N1-A/Hawaii70 cell grown virus: Day 28
|
65 Participants
|
102 Participants
|
|
Number of Participants With Seroprotection Response in 2020
A/H1N1-A/Delaware: Day 0
|
37 Participants
|
32 Participants
|
|
Number of Participants With Seroprotection Response in 2020
A/H1N1-A/Delaware: Day 28
|
43 Participants
|
65 Participants
|
|
Number of Participants With Seroprotection Response in 2020
A/H3N2-A/Hong Kong: Day 0
|
90 Participants
|
73 Participants
|
|
Number of Participants With Seroprotection Response in 2020
A/H3N2-A/Hong Kong: Day 28
|
102 Participants
|
99 Participants
|
|
Number of Participants With Seroprotection Response in 2020
B/Victoria-B/Washington: Day 0
|
62 Participants
|
59 Participants
|
|
Number of Participants With Seroprotection Response in 2020
B/Victoria-B/Washington: Day 28
|
71 Participants
|
86 Participants
|
|
Number of Participants With Seroprotection Response in 2020
B/Yamagata-B/Phuket: Day 0
|
66 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)Population: 2020 Participants
Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition assay will be conducted to assess immunologic outcome. GMTs is defined as the anti-log of the mean of the log2 HI titers
Outcome measures
| Measure |
FluMist Live Attenuated Influenza Vaccine 2019
n=118 Participants
Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally
FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
|
Flucelvax Inactivated Influenza Vaccine 2019
n=112 Participants
Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) at Each Time Point 2020
A/H1N1-A/Hawaii66 egg grown virus: Day 0
|
42 titer
Interval 33.0 to 52.0
|
34 titer
Interval 27.0 to 43.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2020
A/H1N1-A/Hawaii70 cell grown virus: Day 0
|
97 titer
Interval 80.0 to 118.0
|
84 titer
Interval 61.0 to 103.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2020
A/H1N1-A/Delaware: Day 0
|
58 titer
Interval 47.0 to 72.0
|
46 titer
Interval 36.0 to 57.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2020
A/H1N1-A/Delaware: Day 28
|
62 titer
Interval 50.0 to 78.0
|
120 titer
Interval 100.0 to 145.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2020
A/H3N2-A/Hong Kong: Day 0
|
174 titer
Interval 133.0 to 226.0
|
119 titer
Interval 89.0 to 160.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2020
A/H1N1-A/Hawaii66 egg grown virus: Day 28
|
51 titer
Interval 41.0 to 63.0
|
171 titer
Interval 139.0 to 211.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2020
A/H1N1-A/Hawaii70 cell grown virus: Day 28
|
121 titer
Interval 100.0 to 145.0
|
380 titer
Interval 315.0 to 458.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2020
A/H3N2-A/Hong Kong: Day 28
|
234 titer
Interval 190.0 to 288.0
|
370 titer
Interval 282.0 to 484.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2020
B/Victoria-B/Washington: Day 0
|
92 titer
Interval 75.0 to 114.0
|
88 titer
Interval 70.0 to 111.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2020
B/Victoria-B/Washington: Day 28
|
116 titer
Interval 95.0 to 142.0
|
212 titer
Interval 175.0 to 258.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2020
B/Yamagata-B/Phuket: Day 0
|
98 titer
Interval 83.0 to 118.0
|
87 titer
Interval 71.0 to 107.0
|
|
Geometric Mean Titers (GMTs) at Each Time Point 2020
B/Yamagata-B/Phuket: Day 28
|
114 titer
Interval 96.0 to 135.0
|
214 titer
Interval 184.0 to 249.0
|
Adverse Events
FluMist Live Attenuated Influenza Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Flucelvax Inactivated Influenza Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place