Trial Outcomes & Findings for Live Attenuated Influenza Vaccine (LAIV) Versus Trivalent Inactivated Influenza Vaccine in Healthy Adults 18-49 Years (NCT NCT03101462)
NCT ID: NCT03101462
Last Updated: 2019-03-06
Results Overview
Geometric mean hemagglutination inhibition titers to three different influenza viruses
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
38 participants
Primary outcome timeframe
Day 0, Day 7, and Day 45
Results posted on
2019-03-06
Participant Flow
Participant milestones
| Measure |
Group 1 Inactivated Influenza Vaccine (IIV)
Subjects aged 18-49 years received one dose of Inactivated Influenza Vaccine (IIV) intramuscularly.
|
Group 2 Live Attenuated Influenza Vaccine (LAIV)
Subjects 18-49 years of age received one dose of Live Attenuated Influenza Vaccine (LAIV) intranasally.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Group 1 Inactivated Influenza Vaccine (IIV)
Subjects aged 18-49 years received one dose of Inactivated Influenza Vaccine (IIV) intramuscularly.
|
Group 2 Live Attenuated Influenza Vaccine (LAIV)
Subjects 18-49 years of age received one dose of Live Attenuated Influenza Vaccine (LAIV) intranasally.
|
|---|---|---|
|
Overall Study
Missed Visit 02 and/or Visit 03
|
1
|
1
|
Baseline Characteristics
Live Attenuated Influenza Vaccine (LAIV) Versus Trivalent Inactivated Influenza Vaccine in Healthy Adults 18-49 Years
Baseline characteristics by cohort
| Measure |
Inactivated Influenza Vaccine (IIV)
n=19 Participants
Eighteen subjects received one dose 0.5 mL of Inactivated Influenza Vaccine intramuscularly on Day 0.
|
Live Attenuated Influenza Vaccine (IIV)
n=19 Participants
Eighteen subjects received one dose 0.5 mL Live Attenuated Influenza Vaccine intranasally on Day 0.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
|
Age
|
33.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
31.2 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0, Day 7, and Day 45Population: For IIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03. For LAIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03
Geometric mean hemagglutination inhibition titers to three different influenza viruses
Outcome measures
| Measure |
Inactivated Influenza Vaccine (IIV)
n=19 Participants
One 0.5 mL dose of IIV given intramuscularly.
|
Live Attenuated Influenza Vaccine (LAIV)
n=19 Participants
One 0.5 mL dose of LAIV given intranasally.
|
|---|---|---|
|
Serum Antibody Responses
Influenza A virus subtype H1N1 (A/H1N1) Day 0
|
11.76 Titers
Interval 6.2 to 22.4
|
11.11 Titers
Interval 6.3 to 19.9
|
|
Serum Antibody Responses
A/H1N1 Day 7
|
47.03 Titers
Interval 24.3 to 91.1
|
9.33 Titers
Interval 5.4 to 16.3
|
|
Serum Antibody Responses
A/H1N1 Day 45
|
101.59 Titers
Interval 51.6 to 200.0
|
12.70 Titers
Interval 7.0 to 23.2
|
|
Serum Antibody Responses
Influenza A virus subtype H3N2 (A/H3N2) Day 0
|
6.35 Titers
Interval 4.1 to 9.9
|
7.44 Titers
Interval 4.6 to 12.0
|
|
Serum Antibody Responses
A/H3N2 Day 7
|
17.96 Titers
Interval 10.5 to 30.8
|
7.13 Titers
Interval 4.1 to 11.7
|
|
Serum Antibody Responses
A/H3N2 Day 45
|
32.00 Titers
Interval 17.5 to 58.4
|
9.70 Titers
Interval 5.9 to 16.0
|
|
Serum Antibody Responses
Influenza B Day 0
|
7.41 Titers
Interval 5.2 to 10.6
|
10.71 Titers
Interval 6.6 to 17.5
|
|
Serum Antibody Responses
Influenza B Day 7
|
21.77 Titers
Interval 14.2 to 33.4
|
11.31 Titers
Interval 6.8 to 18.77
|
|
Serum Antibody Responses
Influenza B Day 45
|
40.32 Titers
Interval 24.4 to 66.7
|
12.70 Titers
Interval 7.9 to 20.5
|
PRIMARY outcome
Timeframe: Day 0, Day 7, and Day 45Population: For IIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03. For LAIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03.
Number of Interferon gamma ELISPOT spot forming cells (SFC) per million Peripheral Blood Mononuclear Cells (PBMCs) were calculated.
Outcome measures
| Measure |
Inactivated Influenza Vaccine (IIV)
n=19 Participants
One 0.5 mL dose of IIV given intramuscularly.
|
Live Attenuated Influenza Vaccine (LAIV)
n=19 Participants
One 0.5 mL dose of LAIV given intranasally.
|
|---|---|---|
|
T-cell Responses
Medium Alone Day 0
|
1.53 Cells/Million PBMC
Standard Error 0.51
|
2.51 Cells/Million PBMC
Standard Error 1.05
|
|
T-cell Responses
Medium Alone Day 7
|
6.17 Cells/Million PBMC
Standard Error 4.21
|
1.05 Cells/Million PBMC
Standard Error 0.29
|
|
T-cell Responses
Medium Alone Day 45
|
1.11 Cells/Million PBMC
Standard Error 0.31
|
2.35 Cells/Million PBMC
Standard Error 0.90
|
|
T-cell Responses
Peptide Pool 1 + Peptide Pool 2 Day 0
|
75.55 Cells/Million PBMC
Standard Error 23.12
|
61.52 Cells/Million PBMC
Standard Error 17.09
|
|
T-cell Responses
Peptide Pool 1 + Peptide Pool 2 Day 7
|
88.76 Cells/Million PBMC
Standard Error 26.98
|
81.11 Cells/Million PBMC
Standard Error 14.55
|
|
T-cell Responses
Peptide Pool 1 + Peptide Pool 2 Day 45
|
69.94 Cells/Million PBMC
Standard Error 19.03
|
65.55 Cells/Million PBMC
Standard Error 15.14
|
|
T-cell Responses
Live H3N2 Day 0
|
157.90 Cells/Million PBMC
Standard Error 29.93
|
126.20 Cells/Million PBMC
Standard Error 28.71
|
|
T-cell Responses
Live H3N2 Day 7
|
256.79 Cells/Million PBMC
Standard Error 60.12
|
254.26 Cells/Million PBMC
Standard Error 49.36
|
|
T-cell Responses
Live H3N2 Day 45
|
180.99 Cells/Million PBMC
Standard Error 35.49
|
146.99 Cells/Million PBMC
Standard Error 19.72
|
|
T-cell Responses
FluMist Day 0
|
39.26 Cells/Million PBMC
Standard Error 12.61
|
43.16 Cells/Million PBMC
Standard Error 12.46
|
|
T-cell Responses
FluMist Day 7
|
90.25 Cells/Million PBMC
Standard Error 24.83
|
104.81 Cells/Million PBMC
Standard Error 43.29
|
|
T-cell Responses
Flu Mist Day 45
|
70.00 Cells/Million PBMC
Standard Error 21.07
|
49.48 Cells/Million PBMC
Standard Error 13.68
|
PRIMARY outcome
Timeframe: Day 0, Day 7, and Day 45Population: For IIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03. For LAIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03.
Mean absolute numbers of CD4(+), Carboxyfluorescein succinimidyl ester \[CFSE(low)\] IFN-gamma(+), and T cells after activation with a specific antigen measured by flow cytometry
Outcome measures
| Measure |
Inactivated Influenza Vaccine (IIV)
n=19 Participants
One 0.5 mL dose of IIV given intramuscularly.
|
Live Attenuated Influenza Vaccine (LAIV)
n=19 Participants
One 0.5 mL dose of LAIV given intranasally.
|
|---|---|---|
|
Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation
Medium Day 0
|
92.79 T Cells
Standard Error 38.19
|
83.80 T Cells
Standard Error 20.60
|
|
Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation
Medium Day 7
|
1075.24 T Cells
Standard Error 711.71
|
65.45 T Cells
Standard Error 18.04
|
|
Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation
Medium Day 45
|
338.86 T Cells
Standard Error 224.16
|
144.58 T Cells
Standard Error 64.94
|
|
Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation
Live H3N2 Day 0
|
15939.07 T Cells
Standard Error 5984.03
|
22958.77 T Cells
Standard Error 8371.46
|
|
Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation
Live H3N2 Day 7
|
32527.86 T Cells
Standard Error 11165.21
|
28557.23 T Cells
Standard Error 8835.01
|
|
Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation
Live H3N2 Day 45
|
21320.85 T Cells
Standard Error 6054.77
|
15654.57 T Cells
Standard Error 4626.64
|
|
Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation
FluMist Day 0
|
14009.94 T Cells
Standard Error 6259.10
|
12552.22 T Cells
Standard Error 3718.47
|
|
Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation
Flu Mist Day 7
|
26999.98 T Cells
Standard Error 9510.82
|
24265.06 T Cells
Standard Error 5147.71
|
|
Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation
Flu Mist Day 45
|
21704.19 T Cells
Standard Error 6455.24
|
14618.15 T Cells
Standard Error 4314.62
|
PRIMARY outcome
Timeframe: Day 0 and Day 45Population: For IIV group, 18 subjects completed Visit 03. For LAIV group, 18 subjects completed Visit 03.
Influenza virus strain-specific nasal wash secretory immunoglobulin A (IgA) titers by ELISA was measured
Outcome measures
| Measure |
Inactivated Influenza Vaccine (IIV)
n=19 Participants
One 0.5 mL dose of IIV given intramuscularly.
|
Live Attenuated Influenza Vaccine (LAIV)
n=19 Participants
One 0.5 mL dose of LAIV given intranasally.
|
|---|---|---|
|
Secretory Immunoglobulin A (IgA) Responses
Influenza A/H1N1 Day 0
|
18 Titers
Interval 1.25 to 64.0
|
16.25 Titers
Interval 3.0 to 41.0
|
|
Secretory Immunoglobulin A (IgA) Responses
Influenza A/H1N1 Day 45
|
20.75 Titers
Interval 1.25 to 2328.0
|
28.5 Titers
Interval 4.0 to 197.0
|
|
Secretory Immunoglobulin A (IgA) Responses
Influenza A/H3N2 Day 0
|
26.5 Titers
Interval 5.0 to 69.0
|
32.25 Titers
Interval 1.25 to 88.0
|
|
Secretory Immunoglobulin A (IgA) Responses
Influenza A/H3N2 Day 45
|
31.5 Titers
Interval 3.0 to 476.0
|
57.25 Titers
Interval 10.0 to 458.0
|
|
Secretory Immunoglobulin A (IgA) Responses
Influenza B Day 0
|
16 Titers
Interval 3.0 to 50.0
|
9.75 Titers
Interval 3.0 to 47.0
|
|
Secretory Immunoglobulin A (IgA) Responses
Influenza B Day 45
|
16.5 Titers
Interval 1.25 to 77.0
|
16.75 Titers
Interval 5.0 to 113.0
|
PRIMARY outcome
Timeframe: Day 7Hemagglutinin (HA) specific nasal wash secretory immunoglobulin A (IgA) of serum reactivity with HA bound to ELISA plates.
Outcome measures
| Measure |
Inactivated Influenza Vaccine (IIV)
n=18 Participants
One 0.5 mL dose of IIV given intramuscularly.
|
Live Attenuated Influenza Vaccine (LAIV)
n=18 Participants
One 0.5 mL dose of LAIV given intranasally.
|
|---|---|---|
|
Hemagglutinin Immunoglobulin A (IgA) Responses
IgA anti-H1N1 HA Day 7
|
2.32 Fold change
Standard Error 0.40
|
8.42 Fold change
Standard Error 3.51
|
|
Hemagglutinin Immunoglobulin A (IgA) Responses
IgA anti-H3N2 Day 7
|
1.77 Fold change
Standard Error 0.24
|
9.42 Fold change
Standard Error 4.98
|
|
Hemagglutinin Immunoglobulin A (IgA) Responses
IgA anti-Influenza B Day 7
|
1.94 Fold change
Standard Error 0.58
|
9.55 Fold change
Standard Error 4.52
|
Adverse Events
Group 1 Licensed Trivalent FluMist
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 1 Inactvated Trivalent 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
| Measure |
Group 1 Licensed Trivalent FluMist
n=19 participants at risk
Subjects received one dose of Licensed Trivalent FluMist at Day 0.
|
Group 1 Inactvated Trivalent Influenza Vaccine
n=18 participants at risk
Subjects received one dose of Inactivated Trivalent Influenza Vaccine at Day 0.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected from Day 0 through Day 28. Serious Adverse Events were collected from Day 0 through Day 180.
|
0.00%
0/18 • Adverse Events were collected from Day 0 through Day 28. Serious Adverse Events were collected from Day 0 through Day 180.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place