Trial Outcomes & Findings for Safety and Immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 Monovalent Influenza Vaccines (NCT NCT03999554)
NCT ID: NCT03999554
Last Updated: 2022-03-04
Results Overview
Record adverse events following one and two administrations of the Bris10 M2SR influenza vaccine to determine the number and percentage of study participants who experience any vaccine associated adverse events (AEs) or serious adverse events (SAEs) after Bris10 M2SR or placebo administration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
206 participants
Primary outcome timeframe
From baseline through study completion (Day 209)
Results posted on
2022-03-04
Participant Flow
Participant milestones
| Measure |
Low Dose Sing2016 M2SR
Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29
LD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Medium Dose Sing2016 M2SR
Medium dose Sing2016 M2SR will be administered intranasally on days 1 and 29
MD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
High Dose Sing2016 M2SR
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Low Dose Bris10 M2SR
Low dose Bris10 M2SR will be administered intranasally on days 1 and 29
LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
41
|
40
|
42
|
41
|
|
Overall Study
COMPLETED
|
36
|
34
|
28
|
35
|
32
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
12
|
7
|
9
|
Reasons for withdrawal
| Measure |
Low Dose Sing2016 M2SR
Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29
LD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Medium Dose Sing2016 M2SR
Medium dose Sing2016 M2SR will be administered intranasally on days 1 and 29
MD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
High Dose Sing2016 M2SR
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Low Dose Bris10 M2SR
Low dose Bris10 M2SR will be administered intranasally on days 1 and 29
LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
4
|
5
|
8
|
|
Overall Study
Protocol Violation
|
0
|
0
|
5
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
2
|
1
|
1
|
|
Overall Study
failure to comply with protocol requirements
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 Monovalent Influenza Vaccines
Baseline characteristics by cohort
| Measure |
Low Dose Sing2016 M2SR
n=42 Participants
Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29
LD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Medium Dose Sing2016 M2SR
n=41 Participants
Medium dose Sing2016 M2SR will be administered intranasally on days 1 and 29
MD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
High Dose Sing2016 M2SR
n=40 Participants
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Low Dose Bris10 M2SR
n=42 Participants
Low dose Bris10 M2SR will be administered intranasally on days 1 and 29
LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=41 Participants
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
Total
n=206 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
206 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
146 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
96 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
110 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
166 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From baseline through study completion (Day 209)Population: Study participants who received at least one inoculation were included.
Record adverse events following one and two administrations of the Bris10 M2SR influenza vaccine to determine the number and percentage of study participants who experience any vaccine associated adverse events (AEs) or serious adverse events (SAEs) after Bris10 M2SR or placebo administration.
Outcome measures
| Measure |
Low Dose Bris10 M2SR
n=42 Participants
Low dose Bris10 M2SR will be administered intranasally on days 1 and 29
LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=41 Participants
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
High Dose Sing2016 M2SR
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
|---|---|---|---|---|
|
Number of Participants With Local and Systemic Adverse Events (AEs) Through 29 Days Post-vaccination With Bris10 M2SR and Cumulatively Through Day 209
|
28 Participants
|
24 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From baseline through study completion (Day 209)Population: Study participants who received at least one inoculation were included.
Record adverse events following one and two administrations of the Sing2016 M2SR influenza vaccine to determine the number and percentage of study participants who experience any vaccine associated adverse events (AEs) or serious adverse events (SAEs) after Sing2016 M2SR or placebo administration.
Outcome measures
| Measure |
Low Dose Bris10 M2SR
n=42 Participants
Low dose Bris10 M2SR will be administered intranasally on days 1 and 29
LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=41 Participants
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
High Dose Sing2016 M2SR
n=40 Participants
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=41 Participants
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
|---|---|---|---|---|
|
Number of Participants With Local and Systemic Adverse Events (AEs) Through 29 Days Post-vaccination With Sing2016 M2SR and Cumulatively Through Day 209
|
26 Participants
|
29 Participants
|
30 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: From baseline through 28 days post-dose 1 (Day 29)Population: Study subjects who received at least one inoculation were included.
Assess the humoral immunogenicity of one administration of Bris10 M2SR vaccine to Bris 10 by HAI at day 29.
Outcome measures
| Measure |
Low Dose Bris10 M2SR
n=38 Participants
Low dose Bris10 M2SR will be administered intranasally on days 1 and 29
LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=38 Participants
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
High Dose Sing2016 M2SR
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
|---|---|---|---|---|
|
Percentage of Bris10 M2SR Subjects Demonstrating Seroconversion to Vaccine HA
|
28.9 Percentage of subjects
Interval 15.4 to 45.9
|
10.5 Percentage of subjects
Interval 2.9 to 24.8
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline through 28 days post-dose 1 (Day 29)Population: Study subjects who received at least one inoculation were included.
Assess the humoral immunogenicity of one administration of Sing2016 M2SR vaccine to Sing2016 by HAI at day 29
Outcome measures
| Measure |
Low Dose Bris10 M2SR
n=40 Participants
Low dose Bris10 M2SR will be administered intranasally on days 1 and 29
LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=38 Participants
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
High Dose Sing2016 M2SR
n=31 Participants
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=38 Participants
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
|---|---|---|---|---|
|
Percentage of Sing2016 M2SR Subjects Demonstrating Seroconversion to Vaccine HA
|
27.5 Percentage of participants
Interval 14.6 to 43.9
|
36.8 Percentage of participants
Interval 21.8 to 54.0
|
71.0 Percentage of participants
Interval 52.0 to 85.8
|
0 Percentage of participants
Interval 0.0 to 9.3
|
SECONDARY outcome
Timeframe: From baseline through 28 days post-dose 2 (Day 57)Population: Study subjects who received at least one inoculation were included.
Assess the humoral immunogenicity of two administrations of Bris10 M2SR vaccine to Bris 10 by HAI at d57.
Outcome measures
| Measure |
Low Dose Bris10 M2SR
n=37 Participants
Low dose Bris10 M2SR will be administered intranasally on days 1 and 29
LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=35 Participants
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
High Dose Sing2016 M2SR
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
|---|---|---|---|---|
|
Percentage of Bris10 M2SR Subjects Demonstrating Seroconversion to Vaccine HA
|
40.5 Percentage of subjects
Interval 24.8 to 57.9
|
14.3 Percentage of subjects
Interval 4.8 to 30.3
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline through 28 days post-dose 2 (Day 57)Population: Study subjects who received at least one inoculation were included.
Assess the humoral immunogenicity of two administrations of Sing2016 M2SR vaccine to Sing2016 by HAI at day 57
Outcome measures
| Measure |
Low Dose Bris10 M2SR
n=38 Participants
Low dose Bris10 M2SR will be administered intranasally on days 1 and 29
LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=36 Participants
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
High Dose Sing2016 M2SR
n=31 Participants
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=35 Participants
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
|---|---|---|---|---|
|
Percentage of Sing2016 M2SR Subjects Demonstrating Seroconversion to Vaccine HA
|
47.4 Percentage of subjects
Interval 31.0 to 64.2
|
55.6 Percentage of subjects
Interval 38.1 to 72.1
|
80.6 Percentage of subjects
Interval 62.5 to 92.5
|
0 Percentage of subjects
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: From baseline through 28 days post-dose 1 (Day 29)Population: Study subjects who received at least one inoculation were included.
Assess the mucosal immunogenicity of one administration of Bris10 M2SR vaccine to Bris 10 by ELISA at day 29.
Outcome measures
| Measure |
Low Dose Bris10 M2SR
n=36 Participants
Low dose Bris10 M2SR will be administered intranasally on days 1 and 29
LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=36 Participants
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
High Dose Sing2016 M2SR
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
|---|---|---|---|---|
|
Percentage of Bris10 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA
|
22.2 Percentage of subjects
Interval 10.1 to 39.2
|
25.0 Percentage of subjects
Interval 12.1 to 42.2
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline through 28 days post-dose 2 (Day 57)Population: Study subjects who received at least one inoculation were included.
Assess the mucosal immunogenicity of two administrations of Bris10 M2SR vaccine to Bris 10 by ELISA at day 57.
Outcome measures
| Measure |
Low Dose Bris10 M2SR
n=33 Participants
Low dose Bris10 M2SR will be administered intranasally on days 1 and 29
LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=31 Participants
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
High Dose Sing2016 M2SR
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
|---|---|---|---|---|
|
Percentage of Bris10 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA
|
39.4 Percentage of subjects
Interval 22.9 to 57.9
|
25.8 Percentage of subjects
Interval 11.9 to 44.6
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline through 28 days post-dose 2 (Day 57)Population: Study subjects who received at least one inoculation were included.
Assess the mucosal immunogenicity of two administrations of Sing2016 M2SR vaccine to Sing2016 by ELISA at day 57
Outcome measures
| Measure |
Low Dose Bris10 M2SR
n=35 Participants
Low dose Bris10 M2SR will be administered intranasally on days 1 and 29
LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=33 Participants
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
High Dose Sing2016 M2SR
n=28 Participants
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=31 Participants
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
|---|---|---|---|---|
|
Percentage of Sing2016 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA
|
20 Percentage of subjects
Interval 8.4 to 36.9
|
45.5 Percentage of subjects
Interval 28.1 to 63.6
|
60.7 Percentage of subjects
Interval 40.6 to 78.5
|
19.4 Percentage of subjects
Interval 7.5 to 37.5
|
SECONDARY outcome
Timeframe: From baseline through 28 days post-dose 1 (Day 29)Population: Study subjects who received at least one inoculation were included.
Assess the mucosal immunogenicity of one administration of Sing2016 M2SR vaccine to Sing2016 by ELISA at day 29
Outcome measures
| Measure |
Low Dose Bris10 M2SR
n=38 Participants
Low dose Bris10 M2SR will be administered intranasally on days 1 and 29
LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=36 Participants
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
High Dose Sing2016 M2SR
n=29 Participants
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=36 Participants
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
|---|---|---|---|---|
|
Percentage of Sing2016 M2SR Subjects Demonstrating Mucosal Responses to Vaccine HA
|
15.8 Percentage of subjects
Interval 6.0 to 31.3
|
22.2 Percentage of subjects
Interval 10.1 to 39.2
|
37.9 Percentage of subjects
Interval 20.7 to 57.7
|
19.4 Percentage of subjects
Interval 8.2 to 36.0
|
Adverse Events
Low Dose Sing2016 M2SR
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Medium Dose Sing2016 M2SR
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
High Dose Sing2016 M2SR
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Low Dose Bris10 M2SR
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose Sing2016 M2SR
n=42 participants at risk
Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29
LD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Medium Dose Sing2016 M2SR
n=41 participants at risk
Medium dose Sing2016 M2SR will be administered intranasally on days 1 and 29
MD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
High Dose Sing2016 M2SR
n=40 participants at risk
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Low Dose Bris10 M2SR
n=42 participants at risk
Low dose Bris10 M2SR will be administered intranasally on days 1 and 29
LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=41 participants at risk
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
papillary thyroid cancer
|
0.00%
0/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
2.4%
1/41 • Number of events 1 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
Other adverse events
| Measure |
Low Dose Sing2016 M2SR
n=42 participants at risk
Low dose Sing2016 M2SR will be administered intranasally on days 1 and 29
LD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Medium Dose Sing2016 M2SR
n=41 participants at risk
Medium dose Sing2016 M2SR will be administered intranasally on days 1 and 29
MD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
High Dose Sing2016 M2SR
n=40 participants at risk
High dose Sing2016 M2SR will be administered intranasally on days 1 and 29
HD Sing2016 M2SR H3N2 influenza vaccine: This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Low Dose Bris10 M2SR
n=42 participants at risk
Low dose Bris10 M2SR will be administered intranasally on days 1 and 29
LD Bris10 M2SR H3N2 influenza vaccine: This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
|
Placebo
n=41 participants at risk
Saline will be administered intranasally on days 1 and 29
Placebo: This group will receive saline placebo administered intranasally.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
26.2%
11/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
22.0%
9/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
37.5%
15/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
31.0%
13/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
34.1%
14/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
21.4%
9/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
22.0%
9/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
25.0%
10/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
11.9%
5/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
14.6%
6/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhea
|
19.0%
8/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
29.3%
12/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
30.0%
12/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
19.0%
8/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
24.4%
10/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Respiratory, thoracic and mediastinal disorders
throat irritation
|
19.0%
8/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
9.8%
4/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
12.5%
5/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
9.5%
4/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
14.6%
6/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
9.5%
4/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
12.2%
5/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
20.0%
8/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
16.7%
7/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
7.3%
3/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Respiratory, thoracic and mediastinal disorders
nasal discomfort
|
7.1%
3/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
7.3%
3/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
2.5%
1/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
7.1%
3/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
4.9%
2/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Respiratory, thoracic and mediastinal disorders
upper airway cough syndrome
|
4.8%
2/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
2.4%
1/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
0.00%
0/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
4.9%
2/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
2.5%
1/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
2.4%
1/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
2.4%
1/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Respiratory, thoracic and mediastinal disorders
nasal dryness
|
0.00%
0/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
7.3%
3/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
5.0%
2/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
2.4%
1/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
2.4%
1/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Respiratory, thoracic and mediastinal disorders
nasal pruritis
|
0.00%
0/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
7.3%
3/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
2.4%
1/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
General disorders
fatigue
|
31.0%
13/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
19.5%
8/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
25.0%
10/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
33.3%
14/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
19.5%
8/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
General disorders
pyrexia
|
11.9%
5/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
7.3%
3/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
7.5%
3/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
2.4%
1/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
2.4%
1/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Nervous system disorders
headache
|
28.6%
12/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
22.0%
9/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
27.5%
11/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
33.3%
14/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
24.4%
10/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
21.4%
9/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
14.6%
6/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
22.5%
9/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
16.7%
7/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
9.8%
4/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
14.3%
6/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
9.8%
4/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
7.5%
3/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
4.8%
2/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
7.3%
3/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Gastrointestinal disorders
nausea
|
9.5%
4/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
2.4%
1/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
5.0%
2/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
4.8%
2/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
12.2%
5/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Investigations
AAT increase
|
4.8%
2/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Investigations
blood creatinine phosphate increase
|
2.4%
1/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
4.9%
2/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
2.4%
1/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
2.4%
1/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Investigations
blood urine
|
0.00%
0/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
5.0%
2/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Investigations
white blood cell increase
|
0.00%
0/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
4.9%
2/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Cardiac disorders
bradycardia
|
0.00%
0/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
4.9%
2/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
2.4%
1/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
0.00%
0/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
5.0%
2/40 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/42 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
0.00%
0/41 • Adverse events were monitored continuously from first administration of IP until study day 57. SAEs were collected until study day 209.
Administration site and solicited AEs were recorded through 7 days after each vaccination (Days 8 and 29), unsolicited AEs were recorded through 28 days after the last vaccination (Day 57) and SAEs were recorded until Day 209.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee SPONSOR has exclusive right to publish and authorize study publications or communications. INVESTIGATOR makes no presentations/publications of the Study or its results without prior SPONSOR review and approval. SPONSOR will have 90 days to request amendments including but not limited to details that may be detrimental to its intellectual property interests or to the conduct, completion, or analysis of the results of the Study by SPONSOR or its affiliates.
- Publication restrictions are in place
Restriction type: OTHER