Trial Outcomes & Findings for Assess the Safety and Immunogenicity of One or Two Doses of Sing2016 M2SR H3N2 Influenza Vaccine (NCT NCT04960397)
NCT ID: NCT04960397
Last Updated: 2025-08-03
Results Overview
Number and percentage of participants in Cohorts 1-4 each and across Cohorts 1-4 who experience systemic (solicited or local) reactogenicity events, of all severity grades and by grade
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
140 participants
Primary outcome timeframe
Day of first vaccination through 7 days post-dose 1
Results posted on
2025-08-03
Participant Flow
Participants were healthy children (ages 2-17 years) meeting all protocol-defined eligibility criteria. Recruited between August 19, 2021 and September 15, 2023. Of the 148 screened participants, 140 were eligible for enrollment and were randomized. No participants were enrolled into Cohorts 5, 6, or 7.
Participant milestones
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose Placebo
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 3 - 2-8 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 - 2-8 Yrs, 1 Dose Placebo
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 4 - 2-8 Yrs, 2 Doses 10^9 TCID50 Sing2016 M2SR H3N2
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
14
|
30
|
15
|
15
|
10
|
14
|
11
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Parent/Guardian
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
COMPLETED
|
30
|
14
|
28
|
14
|
15
|
10
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
1
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assess the Safety and Immunogenicity of One or Two Doses of Sing2016 M2SR H3N2 Influenza Vaccine
Baseline characteristics by cohort
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=30 Participants
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose Placebo
n=15 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 3 - 2-8 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=15 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 - 2-8 Yrs, 1 Dose Placebo
n=10 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 4 - 2-8 Yrs, 2 Doses 10^9 TCID50 Sing2016 M2SR H3N2
n=14 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
n=11 Participants
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
12.5 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
13.4 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
5.3 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
4.3 years
STANDARD_DEVIATION 2 • n=4 Participants
|
5.7 years
STANDARD_DEVIATION 2 • n=21 Participants
|
5.4 years
STANDARD_DEVIATION 2.1 • n=10 Participants
|
5.1 years
STANDARD_DEVIATION 2.2 • n=115 Participants
|
5.2 years
STANDARD_DEVIATION 1.8 • n=6 Participants
|
7.6 years
STANDARD_DEVIATION 4.1 • n=6 Participants
|
|
Age, Customized
2-4 years old
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
32 Participants
n=6 Participants
|
|
Age, Customized
5-8 years old
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
63 Participants
n=6 Participants
|
|
Age, Customized
9-17 years old
|
31 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
45 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
67 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
73 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
11 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
9 Participants
n=6 Participants
|
129 Participants
n=6 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
108 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
|
Race (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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
15 participants
n=4 Participants
|
15 participants
n=21 Participants
|
10 participants
n=10 Participants
|
14 participants
n=115 Participants
|
11 participants
n=6 Participants
|
140 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Day of first vaccination through 7 days post-dose 1Population: As pre-specified in Statistical Analysis Plan, vaccine recipients in Cohorts 3\&4 are intentionally combined and placebo participants in Cohorts 2-4 are intentionally combined. The safety population consists of all participants who received at least one study influenza vaccination
Number and percentage of participants in Cohorts 1-4 each and across Cohorts 1-4 who experience systemic (solicited or local) reactogenicity events, of all severity grades and by grade
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=30 Participants
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
n=29 Participants
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
n=36 Participants
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
n=90 Participants
All participants who received vaccine
|
All Participants - Placebo
n=50 Participants
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Solicited Event · None
|
14 Participants
|
4 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
30 Participants
|
12 Participants
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Solicited Event · Mild
|
16 Participants
|
5 Participants
|
18 Participants
|
19 Participants
|
23 Participants
|
53 Participants
|
28 Participants
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Solicited Event · Moderate
|
1 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
10 Participants
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Solicited Event · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Local Solicited Event · None
|
21 Participants
|
6 Participants
|
10 Participants
|
10 Participants
|
12 Participants
|
41 Participants
|
18 Participants
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Local Solicited Event · Mild
|
9 Participants
|
4 Participants
|
16 Participants
|
18 Participants
|
21 Participants
|
43 Participants
|
25 Participants
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Local Solicited Event · Moderate
|
1 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
7 Participants
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Local Solicited Event · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Systemic Solicited Event · None
|
16 Participants
|
6 Participants
|
16 Participants
|
16 Participants
|
17 Participants
|
48 Participants
|
23 Participants
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Systemic Solicited Event · Mild
|
15 Participants
|
5 Participants
|
12 Participants
|
12 Participants
|
14 Participants
|
39 Participants
|
19 Participants
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Systemic Solicited Event · Moderate
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
8 Participants
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Systemic Solicited Event · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day of second vaccination through 7 days post-dose 2 (Day 29 to Day 36)Population: The safety population consists of all participants who received at least two study influenza vaccination
Number and percentage of participants in Cohort 4 who experience systemic (solicited or local) reactogenicity events, of all severity grades and by grade
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=12 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=11 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
All participants who received vaccine
|
All Participants - Placebo
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Solicited Event · None
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Solicited Event · Mild
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Solicited Event · Moderate
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Solicited Event · Severe
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Local Solicited Event · None
|
7 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Local Solicited Event · Mild
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Local Solicited Event · Moderate
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Local Solicited Event · Severe
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Systemic Solicited Event · None
|
8 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Systemic Solicited Event · Mild
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Systemic Solicited Event · Moderate
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Participants Experiencing a Solicited Reactogenicity Adverse Event
Any Systemic Solicited Event · Severe
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day of first vaccination through 28 days post-dose 1Population: As pre-specified in Statistical Analysis Plan, vaccine recipients in Cohorts 3\&4 are intentionally combined and placebo participants in Cohorts 2-4 are intentionally combined. The safety population consists of all participants who received at least one study influenza vaccination
Number and percentage of participants in Cohorts 1-4 each and across Cohorts 1-4 who experience unsolicited non-serious adverse events, of all severity grades and by grade
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=30 Participants
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
n=29 Participants
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
n=36 Participants
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
All participants who received vaccine
|
All Participants - Placebo
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Number and Percentage of Participants Experiencing an Unsolicited Non-serious Adverse Event (AE)
Mild
|
1 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number and Percentage of Participants Experiencing an Unsolicited Non-serious Adverse Event (AE)
Moderate
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number and Percentage of Participants Experiencing an Unsolicited Non-serious Adverse Event (AE)
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day of second vaccination through 7 days post-dose 2 (Day 29 to Day 36)Population: The safety population consists of all participants who received at least two study influenza vaccination
Number and percentage of participants in Cohort 4 who experience unsolicited non-serious adverse events, of all severity grades and by grade
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=12 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=11 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
All participants who received vaccine
|
All Participants - Placebo
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Number and Percentage of Participants Experiencing an Unsolicited Non-serious Adverse Event (AE)
Mild
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Participants Experiencing an Unsolicited Non-serious Adverse Event (AE)
Moderate
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number and Percentage of Participants Experiencing an Unsolicited Non-serious Adverse Event (AE)
Severe
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through final visit in the month of April of the calendar year following enrollment (up to 14 months post-baseline)Population: The safety population consists of all participants who received at least one study influenza vaccination
Number and percentage of participants in Cohorts 1-4 each and across Cohorts 1-4 who experience AESIs
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=30 Participants
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
n=15 Participants
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
n=15 Participants
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
n=10 Participants
All participants who received vaccine
|
All Participants - Placebo
n=14 Participants
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
n=11 Participants
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Number and Percentage of Participants Experiencing an Adverse Event of Special Interest (AESI)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through final visit in the month of April of the calendar year following enrollment (up to 14 months post-baseline)Population: The safety population consists of all participants who received at least one study influenza vaccination
Number and percentage of participants in Cohorts 1-4 each and across Cohorts 1-4 who experience serious adverse events (SAEs)
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=30 Participants
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
n=15 Participants
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
n=15 Participants
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
n=10 Participants
All participants who received vaccine
|
All Participants - Placebo
n=14 Participants
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
n=11 Participants
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Number and Percentage of Participants Experiencing a Serious Adverse Event (SAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through final visit in the month of April of the calendar year following enrollment (up to 14 months post-baseline)Population: The safety population consists of all participants who received at least one study influenza vaccination
Number and percentage of participants in Cohorts 1-4 each and across Cohorts 1-4 who experience new-onset chronic medical conditions (NOCMCs)
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=30 Participants
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
n=15 Participants
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
n=15 Participants
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
n=10 Participants
All participants who received vaccine
|
All Participants - Placebo
n=14 Participants
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
n=11 Participants
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Number and Percentage of Participants Experiencing a New-onset Chronic Medical Condition (NOCMC)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 29 (Cohorts 1, 2, and 3), and Day 57 (Cohort 4)Population: The modified intent-to-treat population consists of all participants who received study influenza vaccination and had a baseline and at least one post-baseline sample available corresponding to at least one secondary immunogenicity assay
Titers for each participant are estimated as the geometric mean of technical replicate results. Putative seroprotection is defined as a serum hemagglutination inhibition (HAI) antibody titer greater than or equal to 1:40
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=29 Participants
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
n=15 Participants
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
n=15 Participants
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
n=10 Participants
All participants who received vaccine
|
All Participants - Placebo
n=13 Participants
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
n=11 Participants
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Number and Percentage of Participants With Putative Seroprotection Against an H3N2 M2SR-like Virus
Day 1
|
30 Participants
|
13 Participants
|
16 Participants
|
5 Participants
|
10 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
|
Number and Percentage of Participants With Putative Seroprotection Against an H3N2 M2SR-like Virus
Day 29 (Cohorts 1, 2, 3)
|
30 Participants
|
13 Participants
|
14 Participants
|
4 Participants
|
8 Participants
|
5 Participants
|
—
|
—
|
|
Number and Percentage of Participants With Putative Seroprotection Against an H3N2 M2SR-like Virus
Day 57 (Cohort 4)
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 29 (Cohorts 1, 2, and 3), and Day 57 (Cohort 4)Population: The modified intent-to-treat population consists of all participants who received study influenza vaccination and had a baseline and at least one post-baseline sample available corresponding to at least one secondary immunogenicity assay
Titers for each participant are estimated as the geometric mean of technical replicate results.
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=29 Participants
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
n=15 Participants
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
n=15 Participants
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
n=10 Participants
All participants who received vaccine
|
All Participants - Placebo
n=13 Participants
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
n=11 Participants
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Number and Percentage of Participants With Serum Neutralizing Antibody Titer Against an H3N2 M2SR-like Virus Greater Than or Equal to 1:40
Day 1
|
31 Participants
|
13 Participants
|
19 Participants
|
9 Participants
|
10 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
|
Number and Percentage of Participants With Serum Neutralizing Antibody Titer Against an H3N2 M2SR-like Virus Greater Than or Equal to 1:40
Day 29 (Cohorts 1, 2, 3)
|
31 Participants
|
13 Participants
|
19 Participants
|
9 Participants
|
9 Participants
|
5 Participants
|
—
|
—
|
|
Number and Percentage of Participants With Serum Neutralizing Antibody Titer Against an H3N2 M2SR-like Virus Greater Than or Equal to 1:40
Day 57 (Cohort 4)
|
—
|
—
|
—
|
—
|
—
|
—
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 29 (Cohorts 1, 2, and 3), and Day 57 (Cohort 4)Population: The modified intent-to-treat population consists of all participants who received study influenza vaccination and had a baseline and at least one post-baseline sample available corresponding to at least one secondary immunogenicity assay
Titers for each participant are estimated as the geometric mean of technical replicate results, and the geometric mean is taken again across participants in each group at each time point.
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=29 Participants
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
n=15 Participants
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
n=15 Participants
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
n=10 Participants
All participants who received vaccine
|
All Participants - Placebo
n=13 Participants
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
n=11 Participants
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Against an H3N2 M2SR-like Virus
Day 1
|
250.2 titer
Interval 178.9 to 342.2
|
190.3 titer
Interval 90.5 to 353.3
|
43 titer
Interval 23.6 to 78.1
|
25.2 titer
Interval 13.8 to 50.4
|
51.6 titer
Interval 23.5 to 113.1
|
60.6 titer
Interval 28.3 to 139.3
|
20 titer
Interval 11.7 to 36.0
|
28.3 titer
Interval 16.0 to 54.8
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Against an H3N2 M2SR-like Virus
Day 29 (Cohorts 1, 2, and 3)
|
242 titer
Interval 171.1 to 334.6
|
119.9 titer
Interval 102.5 to 353.3
|
41 titer
Interval 13.1 to 72.7
|
21 titer
Interval 13.5 to 34.5
|
58.2 titer
Interval 26.7 to 134.5
|
50.4 titer
Interval 20.0 to 127.0
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Against an H3N2 M2SR-like Virus
Day 57 (Cohort 4)
|
—
|
—
|
—
|
—
|
—
|
—
|
24.9 titer
Interval 14.4 to 44.0
|
24.9 titer
Interval 13.7 to 46.8
|
SECONDARY outcome
Timeframe: Day 1, Day 29 (Cohorts 1, 2, and 3), and Day 57 (Cohort 4)Population: The modified intent-to-treat population consists of all participants who received study influenza vaccination and had a baseline and at least one post-baseline sample available corresponding to at least one secondary immunogenicity assay
Titers for each participant are estimated as the geometric mean of technical replicate results, and the geometric mean is taken again across participants in each group at each time point.
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=29 Participants
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
n=15 Participants
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
n=15 Participants
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
n=10 Participants
All participants who received vaccine
|
All Participants - Placebo
n=13 Participants
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
n=11 Participants
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing Antibodies Against an H3N2 M2SR-like Virus
Day 1
|
585.2 titers
Interval 409.2 to 837.0
|
499.7 titers
Interval 204.9 to 999.3
|
77.2 titers
Interval 39.5 to 154.4
|
45.9 titers
Interval 21.4 to 100.8
|
85.7 titers
Interval 31.0 to 223.7
|
105.6 titers
Interval 40.0 to 269.2
|
27.5 titers
Interval 13.1 to 59.7
|
46.8 titers
Interval 20.0 to 106.2
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing Antibodies Against an H3N2 M2SR-like Virus
Day 29 (Cohorts 1, 2, 3)
|
598.5 titers
Interval 418.5 to 846.4
|
512.2 titers
Interval 210.1 to 1050.0
|
76.3 titers
Interval 39.5 to 148.9
|
41 titers
Interval 19.0 to 88.3
|
106.8 titers
Interval 36.7 to 320.0
|
89.8 titers
Interval 30.5 to 254.0
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing Antibodies Against an H3N2 M2SR-like Virus
Day 57 (Cohort 4)
|
—
|
—
|
—
|
—
|
—
|
—
|
42.6 titers
Interval 20.6 to 85.2
|
53.1 titers
Interval 22.7 to 120.5
|
SECONDARY outcome
Timeframe: Day 29 (Cohorts 1, 2, and 3) and Day 57 (Cohort 4)Population: The modified intent-to-treat population consists of all participants who received study influenza vaccination and had a baseline and at least one post-baseline sample available corresponding to at least one secondary immunogenicity assay
Titers for each participant are estimated as the geometric mean of technical replicate results. Fold-rise in titers is calculated as the post-vaccination titer divided by the pre-vaccination titer. The geometric mean of fold-rises is taken again across participants in each group at each time point.
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=29 Participants
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
n=15 Participants
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
n=15 Participants
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
n=10 Participants
All participants who received vaccine
|
All Participants - Placebo
n=13 Participants
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
n=11 Participants
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Serum Hemagglutination Inhibition (HAI) Antibody Titers Against an H3N2 M2SR-like Virus
Day 29 (Cohorts 1, 2, and 3)
|
1 Ratio
Interval 0.9 to 1.1
|
1.1 Ratio
Interval 0.9 to 1.3
|
1 Ratio
Interval 0.9 to 1.1
|
1 Ratio
Interval 0.8 to 1.2
|
1 Ratio
Interval 0.8 to 1.3
|
.9 Ratio
Interval 0.8 to 1.0
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serum Hemagglutination Inhibition (HAI) Antibody Titers Against an H3N2 M2SR-like Virus
Day 57 (Cohort 4)
|
—
|
—
|
—
|
—
|
—
|
—
|
1.3 Ratio
Interval 1.1 to 1.8
|
.9 Ratio
Interval 0.7 to 1.2
|
SECONDARY outcome
Timeframe: Day 29 (Cohorts 1, 2, and 3) and Day 57 (Cohort 4)Population: The modified intent-to-treat population consists of all participants who received study influenza vaccination and had a baseline and at least one post-baseline sample available corresponding to at least one secondary immunogenicity assay
Titers for each participant are estimated as the geometric mean of technical replicate results. Fold-rise in titers is calculated as the post-vaccination titer divided by the pre-vaccination titer. The geometric mean of fold-rises is taken again across participants in each group at each time point.
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=29 Participants
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
n=15 Participants
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
n=15 Participants
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
n=10 Participants
All participants who received vaccine
|
All Participants - Placebo
n=13 Participants
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
n=11 Participants
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Serum Neutralizing Antibody Titers Against an H3N2 M2SR-like Virus
Day 29 (Cohorts 1, 2, and 3)
|
1 Ratio
Interval 0.9 to 1.1
|
1 Ratio
Interval 1.0 to 1.1
|
1 Ratio
Interval 0.9 to 1.1
|
1.1 Ratio
Interval 1.0 to 1.2
|
1.2 Ratio
Interval 1.0 to 1.4
|
1 Ratio
Interval 0.8 to 1.1
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Serum Neutralizing Antibody Titers Against an H3N2 M2SR-like Virus
Day 57 (Cohort 4)
|
—
|
—
|
—
|
—
|
—
|
—
|
1.9 Ratio
Interval 1.2 to 3.3
|
1.1 Ratio
Interval 1.0 to 1.3
|
SECONDARY outcome
Timeframe: Day 29 (Cohorts 1, 2, and 3) and Day 57 (Cohort 4)Population: The modified intent-to-treat population consists of all participants who received study influenza vaccination and had a baseline and at least one post-baseline sample available corresponding to at least one secondary immunogenicity assay
Titers for each participant are estimated as the geometric mean of technical replicate results. Fold-rise in titers is calculated as the post-vaccination titer divided by the pre-vaccination titer.
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=29 Participants
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
n=15 Participants
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
n=15 Participants
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
n=10 Participants
All participants who received vaccine
|
All Participants - Placebo
n=13 Participants
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
n=11 Participants
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Greater Than or Equal to 2- and 4-fold Mean Rises in Hemagglutination Inhibition (HAI) Antibody Titer Against an H3N2 M2SR-like Virus
=>2 Fold-rise Day 29 (Cohorts 1, 2, and 3)
|
9.7 percent of participants
Interval 2.0 to 25.8
|
14.3 percent of participants
Interval 1.8 to 42.8
|
6.9 percent of participants
Interval 0.8 to 22.8
|
14.3 percent of participants
Interval 1.8 to 42.8
|
16.7 percent of participants
Interval 2.1 to 48.4
|
0 percent of participants
Interval 0.0 to 33.6
|
—
|
—
|
|
Percentage of Participants With Greater Than or Equal to 2- and 4-fold Mean Rises in Hemagglutination Inhibition (HAI) Antibody Titer Against an H3N2 M2SR-like Virus
=>2 Fold-rise Day 57 (Cohort 4)
|
—
|
—
|
—
|
—
|
—
|
—
|
27.3 percent of participants
Interval 6.0 to 61.0
|
18.2 percent of participants
Interval 2.3 to 51.8
|
|
Percentage of Participants With Greater Than or Equal to 2- and 4-fold Mean Rises in Hemagglutination Inhibition (HAI) Antibody Titer Against an H3N2 M2SR-like Virus
=>4 Fold-rise Day 29 (Cohorts 1, 2, and 3)
|
0 percent of participants
Interval 0.0 to 11.2
|
0 percent of participants
Interval 0.0 to 23.2
|
0 percent of participants
Interval 0.0 to 11.9
|
0 percent of participants
Interval 0.0 to 23.2
|
0 percent of participants
Interval 0.0 to 26.5
|
0 percent of participants
Interval 0.0 to 33.6
|
—
|
—
|
|
Percentage of Participants With Greater Than or Equal to 2- and 4-fold Mean Rises in Hemagglutination Inhibition (HAI) Antibody Titer Against an H3N2 M2SR-like Virus
=>4 Fold-rise Day 57 (Cohort 4)
|
—
|
—
|
—
|
—
|
—
|
—
|
9.1 percent of participants
Interval 0.2 to 41.3
|
0 percent of participants
Interval 0.0 to 28.5
|
SECONDARY outcome
Timeframe: Day 29 (Cohorts 1, 2, and 3) and Day 57 (Cohort 4)Population: The modified intent-to-treat population consists of all participants who received study influenza vaccination and had a baseline and at least one post-baseline sample available corresponding to at least one secondary immunogenicity assay
Titers for each participant are estimated as the geometric mean of technical replicate results. Fold-rise in titers is calculated as the post-vaccination titer divided by the pre-vaccination titer.
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=29 Participants
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
n=15 Participants
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
n=15 Participants
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
n=10 Participants
All participants who received vaccine
|
All Participants - Placebo
n=13 Participants
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
n=11 Participants
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Percent of Participants With Greater Than or Equal to 2- and 4-fold Mean Rises in Serum Neutralizing Antibody Titer Against an H3N2 M2SR-like Virus
=>2 Fold-rise Day 29 (Cohorts 1, 2, and 3)
|
6.5 percent of participants
Interval 0.8 to 21.4
|
0 percent of participants
Interval 0.0 to 23.2
|
10.3 percent of participants
Interval 2.2 to 27.4
|
7.1 percent of participants
Interval 0.2 to 33.9
|
16.7 percent of participants
Interval 2.1 to 48.4
|
0 percent of participants
Interval 0.0 to 33.6
|
—
|
—
|
|
Percent of Participants With Greater Than or Equal to 2- and 4-fold Mean Rises in Serum Neutralizing Antibody Titer Against an H3N2 M2SR-like Virus
=>2 Fold-rise Day 57 (Cohort 4)
|
—
|
—
|
—
|
—
|
—
|
—
|
27.3 percent of participants
Interval 6.0 to 61.0
|
9.1 percent of participants
Interval 0.2 to 41.3
|
|
Percent of Participants With Greater Than or Equal to 2- and 4-fold Mean Rises in Serum Neutralizing Antibody Titer Against an H3N2 M2SR-like Virus
=>4 Fold-rise Day 29 (Cohorts 1, 2, and 3)
|
0 percent of participants
Interval 0.0 to 11.2
|
0 percent of participants
Interval 0.0 to 23.2
|
0 percent of participants
Interval 0.0 to 11.9
|
0 percent of participants
Interval 0.0 to 23.2
|
0 percent of participants
Interval 0.0 to 26.5
|
0 percent of participants
Interval 0.0 to 33.6
|
—
|
—
|
|
Percent of Participants With Greater Than or Equal to 2- and 4-fold Mean Rises in Serum Neutralizing Antibody Titer Against an H3N2 M2SR-like Virus
=>4 Fold-rise Day 57 (Cohort 4)
|
—
|
—
|
—
|
—
|
—
|
—
|
27.3 percent of participants
Interval 6.0 to 61.0
|
0 percent of participants
Interval 0.0 to 28.5
|
SECONDARY outcome
Timeframe: Day 1, Day 29 (Cohorts 1, 2, and 3), and Day 57 (Cohort 4)Population: The modified intent-to-treat population consists of all participants who received study influenza vaccination and had a baseline and at least one post-baseline sample available corresponding to at least one secondary immunogenicity assay
Antigen-specific electrochemiluminescence (ECL) signal is calculated as the antigen specific background-subtracted ECL signal times the dilution factor at the replicate level. secretory Immunoglobulin A (sIgA) specific activity is calculated as the arithmetic mean of the antigen-specific ECL signal replicates divided by the arithmetic mean of the total sIgA concentration replicates. The arithmetic mean is taken again across participants in each group at each time point. Measured in Mean ECL luminosity signal, as arbitrary units (AU) against each antigen over ug/L sIgA. Higher values correspond to stronger response.
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=29 Participants
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
n=15 Participants
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
n=15 Participants
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
n=10 Participants
All participants who received vaccine
|
All Participants - Placebo
n=13 Participants
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
n=11 Participants
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Baseline (Texas)
|
2.1 arbitrary units / ug/L
Interval 1.4 to 2.8
|
4.2 arbitrary units / ug/L
Interval 1.4 to 7.9
|
1.8 arbitrary units / ug/L
Interval 0.8 to 3.4
|
118.6 arbitrary units / ug/L
Interval 1.0 to 352.8
|
3.5 arbitrary units / ug/L
Interval 1.0 to 7.6
|
2.2 arbitrary units / ug/L
Interval 0.7 to 4.0
|
2.1 arbitrary units / ug/L
Interval 1.2 to 3.1
|
2.4 arbitrary units / ug/L
Interval 1.3 to 3.7
|
|
Mean Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Day 29 (Texas)
|
3 arbitrary units / ug/L
Interval 2.1 to 4.0
|
7.2 arbitrary units / ug/L
Interval 1.8 to 14.5
|
2.2 arbitrary units / ug/L
Interval 0.9 to 4.0
|
1.2 arbitrary units / ug/L
Interval 0.9 to 1.7
|
4.5 arbitrary units / ug/L
Interval 1.3 to 8.5
|
9.7 arbitrary units / ug/L
Interval 1.9 to 24.0
|
—
|
—
|
|
Mean Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Day 57 (Texas)
|
—
|
—
|
—
|
—
|
—
|
—
|
14.4 arbitrary units / ug/L
Interval 2.6 to 32.8
|
1.9 arbitrary units / ug/L
Interval 0.8 to 3.2
|
|
Mean Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Baseline (Singapore)
|
3.9 arbitrary units / ug/L
Interval 2.3 to 5.7
|
5.4 arbitrary units / ug/L
Interval 2.4 to 9.4
|
3 arbitrary units / ug/L
Interval 1.0 to 6.1
|
89.3 arbitrary units / ug/L
Interval 1.2 to 263.8
|
6.6 arbitrary units / ug/L
Interval 0.7 to 17.9
|
1.4 arbitrary units / ug/L
Interval 0.5 to 2.8
|
1.5 arbitrary units / ug/L
Interval 0.9 to 2.1
|
2.5 arbitrary units / ug/L
Interval 1.4 to 3.9
|
|
Mean Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Day 29 (Singapore)
|
6.3 arbitrary units / ug/L
Interval 3.9 to 9.4
|
10.6 arbitrary units / ug/L
Interval 3.8 to 18.9
|
3.7 arbitrary units / ug/L
Interval 1.2 to 7.2
|
1.6 arbitrary units / ug/L
Interval 0.8 to 3.0
|
5.8 arbitrary units / ug/L
Interval 1.0 to 14.0
|
1.8 arbitrary units / ug/L
Interval 0.5 to 3.3
|
—
|
—
|
|
Mean Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Day 57 (Singapore)
|
—
|
—
|
—
|
—
|
—
|
—
|
21.3 arbitrary units / ug/L
Interval 3.3 to 49.4
|
1.8 arbitrary units / ug/L
Interval 0.7 to 3.5
|
|
Mean Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Baseline (HongKong)
|
1.4 arbitrary units / ug/L
Interval 1.0 to 2.0
|
1.6 arbitrary units / ug/L
Interval 0.9 to 2.5
|
1.2 arbitrary units / ug/L
Interval 0.7 to 1.9
|
175.4 arbitrary units / ug/L
Interval 1.0 to 523.7
|
1.9 arbitrary units / ug/L
Interval 0.6 to 3.8
|
.9 arbitrary units / ug/L
Interval 0.6 to 1.2
|
1.3 arbitrary units / ug/L
Interval 0.8 to 1.7
|
2.3 arbitrary units / ug/L
Interval 1.0 to 4.3
|
|
Mean Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Day 29 (HongKong)
|
2 arbitrary units / ug/L
Interval 1.4 to 2.6
|
2.6 arbitrary units / ug/L
Interval 0.9 to 5.3
|
1.5 arbitrary units / ug/L
Interval 0.8 to 2.4
|
1.1 arbitrary units / ug/L
Interval 0.7 to 1.6
|
2.2 arbitrary units / ug/L
Interval 1.0 to 3.8
|
8.6 arbitrary units / ug/L
Interval 1.3 to 22.1
|
—
|
—
|
|
Mean Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Day 57 (HongKong)
|
—
|
—
|
—
|
—
|
—
|
—
|
8.4 arbitrary units / ug/L
Interval 1.9 to 18.2
|
1.9 arbitrary units / ug/L
Interval 0.7 to 3.5
|
|
Mean Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Baseline (Cambodia)
|
2 arbitrary units / ug/L
Interval 1.3 to 3.0
|
2.6 arbitrary units / ug/L
Interval 1.1 to 4.5
|
1.6 arbitrary units / ug/L
Interval 0.9 to 2.8
|
133.2 arbitrary units / ug/L
Interval 1.3 to 395.1
|
3.3 arbitrary units / ug/L
Interval 0.7 to 8.1
|
2.1 arbitrary units / ug/L
Interval 0.8 to 4.2
|
1.7 arbitrary units / ug/L
Interval 1.1 to 2.3
|
1.8 arbitrary units / ug/L
Interval 1.0 to 2.7
|
|
Mean Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Day 29 (Cambodia)
|
2.7 arbitrary units / ug/L
Interval 1.8 to 3.7
|
5 arbitrary units / ug/L
Interval 1.3 to 10.7
|
2.1 arbitrary units / ug/L
Interval 1.0 to 3.5
|
1.7 arbitrary units / ug/L
Interval 0.9 to 3.0
|
3.3 arbitrary units / ug/L
Interval 1.2 to 6.7
|
4.8 arbitrary units / ug/L
Interval 1.4 to 11.0
|
—
|
—
|
|
Mean Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Day 57 (Cambodia)
|
—
|
—
|
—
|
—
|
—
|
—
|
15.3 arbitrary units / ug/L
Interval 2.0 to 38.2
|
1.4 arbitrary units / ug/L
Interval 0.7 to 2.6
|
SECONDARY outcome
Timeframe: Day 29 (Cohorts 1, 2, and 3) and Day 57 (Cohort 4)Population: The modified intent-to-treat population consists of all participants who received study influenza vaccination and had a baseline and at least one post-baseline sample available corresponding to at least one secondary immunogenicity assay
Antigen-specific electrochemiluminescence (ECL) signal is calculated as the antigen specific background-subtracted ECL signal times the dilution factor at the replicate level. secretory Immunoglobulin A (sIgA) specific activity is calculated as the arithmetic mean of the antigen-specific ECL signal replicates divided by the arithmetic mean of the total sIgA concentration replicates. The change from baseline is calculated as the post-vaccination response minus the pre-vaccination response. The arithmetic mean of change from baseline is taken again across participants in each group at each time point. Measured in Mean Difference from Baseline in ECL Signal (arbitrary luminescence units) against each antigen over ug/L sIgA. Higher signal represents increased response.
Outcome measures
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 Participants
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 Participants
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=29 Participants
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 & 4 - Vaccine
n=15 Participants
Cohorts 3 and 4 combined
|
Cohort 2, 3, 4 - Placebo
n=15 Participants
Cohorts 2, 3, and 4 combined
|
All Participants - Vaccine
n=10 Participants
All participants who received vaccine
|
All Participants - Placebo
n=13 Participants
All participants who received Placebo
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
n=11 Participants
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change (Difference) From Baseline of Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Day 29 (Texas)
|
1 arbitrary luminescence units / ug/L
Interval 0.3 to 1.8
|
3.5 arbitrary luminescence units / ug/L
Interval 0.0 to 10.3
|
.4 arbitrary luminescence units / ug/L
Interval -0.1 to 1.1
|
-117.4 arbitrary luminescence units / ug/L
Interval -351.8 to 0.3
|
1.1 arbitrary luminescence units / ug/L
Interval -0.9 to 3.4
|
7.6 arbitrary luminescence units / ug/L
Interval 0.4 to 21.0
|
—
|
—
|
|
Mean Change (Difference) From Baseline of Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Day 57 (Texas)
|
—
|
—
|
—
|
—
|
—
|
—
|
12.4 arbitrary luminescence units / ug/L
Interval 1.1 to 29.9
|
-.5 arbitrary luminescence units / ug/L
Interval -1.1 to 0.0
|
|
Mean Change (Difference) From Baseline of Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Day 29 (Singapore)
|
2.4 arbitrary luminescence units / ug/L
Interval 0.6 to 4.8
|
5.2 arbitrary luminescence units / ug/L
Interval 0.3 to 12.9
|
.7 arbitrary luminescence units / ug/L
Interval -0.1 to 1.8
|
-87.7 arbitrary luminescence units / ug/L
Interval -262.1 to 0.3
|
-.9 arbitrary luminescence units / ug/L
Interval -5.1 to 2.0
|
.3 arbitrary luminescence units / ug/L
Interval -1.0 to 1.6
|
—
|
—
|
|
Mean Change (Difference) From Baseline of Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Day 57 (Singapore)
|
—
|
—
|
—
|
—
|
—
|
—
|
19.8 arbitrary luminescence units / ug/L
Interval 1.7 to 47.6
|
-.7 arbitrary luminescence units / ug/L
Interval -1.6 to 0.1
|
|
Mean Change (Difference) From Baseline of Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Day 29 (HongKong)
|
.5 arbitrary luminescence units / ug/L
Interval 0.0 to 1.0
|
1 arbitrary luminescence units / ug/L
Interval -0.7 to 3.7
|
.3 arbitrary luminescence units / ug/L
Interval -0.1 to 0.8
|
-174.3 arbitrary luminescence units / ug/L
Interval -522.7 to 0.2
|
.4 arbitrary luminescence units / ug/L
Interval -0.3 to 1.0
|
7.7 arbitrary luminescence units / ug/L
Interval 0.4 to 21.0
|
—
|
—
|
|
Mean Change (Difference) From Baseline of Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Day 57 (HongKong)
|
—
|
—
|
—
|
—
|
—
|
—
|
7.1 arbitrary luminescence units / ug/L
Interval 0.8 to 16.7
|
-.4 arbitrary luminescence units / ug/L
Interval -1.1 to 0.1
|
|
Mean Change (Difference) From Baseline of Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Day 29 (Cambodia)
|
.6 arbitrary luminescence units / ug/L
Interval -0.1 to 1.4
|
2.4 arbitrary luminescence units / ug/L
Interval -0.4 to 7.5
|
.4 arbitrary luminescence units / ug/L
Interval 0.0 to 1.1
|
-131.4 arbitrary luminescence units / ug/L
Interval -393.0 to 0.0
|
-.1 arbitrary luminescence units / ug/L
Interval -1.8 to 1.1
|
2.7 arbitrary luminescence units / ug/L
Interval 0.2 to 7.0
|
—
|
—
|
|
Mean Change (Difference) From Baseline of Secretory Immunoglobulin A (sIgA) Response (i.e., Specific Activity) as Measured by a Binding Antibody Multiplex Assay (BAMA) in Nasal Lavage Specimens Against an H3N2 M2SR-like Virus
Day 57 (Cambodia)
|
—
|
—
|
—
|
—
|
—
|
—
|
13.6 arbitrary luminescence units / ug/L
Interval 0.6 to 36.7
|
-.3 arbitrary luminescence units / ug/L
Interval -0.6 to 0.0
|
Adverse Events
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Cohort 2 - 2-8 Yrs, 1 Dose Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 3 - 2-8 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 3 - 2-8 Yrs, 1 Dose Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 4 - 2-8 Yrs, 2 Doses 10^9 TCID50 Sing2016 M2SR H3N2
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 participants at risk
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 participants at risk
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=30 participants at risk
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose Placebo
n=15 participants at risk
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 3 - 2-8 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=15 participants at risk
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 - 2-8 Yrs, 1 Dose Placebo
n=10 participants at risk
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 4 - 2-8 Yrs, 2 Doses 10^9 TCID50 Sing2016 M2SR H3N2
n=14 participants at risk
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
n=11 participants at risk
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pharyngitis
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
1/15 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/11 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
Other adverse events
| Measure |
Cohort 1 - 9-17 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=31 participants at risk
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 1 - 9-17 Yrs, 1 Dose Placebo
n=14 participants at risk
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose 10^8 TCID50 Sing2016 M2SR H3N2
n=30 participants at risk
10\^8 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 2 - 2-8 Yrs, 1 Dose Placebo
n=15 participants at risk
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 3 - 2-8 Yrs, 1 Dose 10^9 TCID50 Sing2016 M2SR H3N2
n=15 participants at risk
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. One dose administered intranasally on Day 1.
|
Cohort 3 - 2-8 Yrs, 1 Dose Placebo
n=10 participants at risk
Physiological saline, i.e., 0.9% sodium chloride. One dose administered intranasally on Day 1.
|
Cohort 4 - 2-8 Yrs, 2 Doses 10^9 TCID50 Sing2016 M2SR H3N2
n=14 participants at risk
10\^9 TCID50 of a novel intranasal live attenuated influenza vaccine with a defective M2 gene which renders the virus unable to replicate and generate progeny in animals and in humans, making its infectivity self-limiting. It induces both a mucosal and cell-mediated immune response and is administered intranasally. Supplied by Flugen Inc. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
Cohort 4 - 2-8 Yrs, 2 Doses Placebo
n=11 participants at risk
Physiological saline, i.e., 0.9% sodium chloride. Two doses: one administered intranasally on Day 1, and the second administered intranasally on approximately Day 29.
|
|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Eye pruritus
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
9.1%
1/11 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
9.1%
1/11 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.9%
4/31 • Number of events 4 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
13.3%
2/15 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
20.0%
3/15 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
14.3%
2/14 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
18.2%
2/11 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
9.1%
1/11 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.7%
3/31 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
10.0%
3/30 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
1/15 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
13.3%
2/15 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
10.0%
1/10 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/11 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
21.4%
3/14 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
10.0%
3/30 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
1/15 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
1/15 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
10.0%
1/10 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
18.2%
2/11 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/11 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
9.1%
1/11 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
General disorders
Decreased activity
|
3.2%
1/31 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
21.4%
3/14 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
13.3%
4/30 • Number of events 4 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
1/15 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
18.2%
2/11 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
General disorders
Fatigue
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
9.1%
1/11 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
General disorders
Malaise
|
12.9%
4/31 • Number of events 4 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
28.6%
4/14 • Number of events 4 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
13.3%
4/30 • Number of events 4 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
13.3%
2/15 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
1/15 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
18.2%
2/11 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
General disorders
Pyrexia
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
10.0%
1/10 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
18.2%
2/11 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Infections and infestations
COVID-19
|
3.2%
1/31 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/11 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
9.1%
1/11 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/11 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Infections and infestations
Otitis media
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
3.3%
1/30 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
1/15 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/11 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
3.3%
1/30 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
1/15 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/11 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
10.0%
1/10 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
9.1%
1/11 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
10.0%
1/10 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/11 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
3.3%
1/30 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
1/15 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/11 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
3.3%
1/30 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
13.3%
2/15 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
18.2%
2/11 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/11 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.5%
2/31 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
16.7%
5/30 • Number of events 5 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
20.0%
3/15 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
1/15 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
10.0%
1/10 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
27.3%
3/11 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
14.3%
2/14 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/11 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
2/31 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
14.3%
2/14 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
2/30 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
1/15 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
18.2%
2/11 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
9.1%
1/11 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
2/30 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
1/15 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
1/15 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
10.0%
1/10 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
9.1%
1/11 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
2/30 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
20.0%
3/15 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
1/15 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
21.4%
3/14 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/11 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.1%
5/31 • Number of events 5 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
35.7%
5/14 • Number of events 5 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
20.0%
6/30 • Number of events 6 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
40.0%
6/15 • Number of events 6 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
40.0%
6/15 • Number of events 6 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
30.0%
3/10 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
42.9%
6/14 • Number of events 7 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
27.3%
3/11 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
21.4%
3/14 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
3.3%
1/30 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/11 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
10.0%
3/30 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
13.3%
2/15 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
9.1%
1/11 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.8%
8/31 • Number of events 8 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
35.7%
5/14 • Number of events 5 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
30.0%
9/30 • Number of events 9 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
26.7%
4/15 • Number of events 4 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
40.0%
6/15 • Number of events 6 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
60.0%
6/10 • Number of events 6 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
42.9%
6/14 • Number of events 7 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
36.4%
4/11 • Number of events 5 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
22.6%
7/31 • Number of events 7 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
14.3%
2/14 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
10.0%
3/30 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
13.3%
2/15 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
13.3%
2/15 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
10.0%
1/10 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
18.2%
2/11 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
3.2%
1/31 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/11 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
7.1%
1/14 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
2/30 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
20.0%
3/15 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
10.0%
1/10 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/11 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
9.1%
1/11 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
9.7%
3/31 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
35.7%
5/14 • Number of events 5 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
30.0%
9/30 • Number of events 9 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
13.3%
2/15 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
13.3%
2/15 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
20.0%
2/10 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
21.4%
3/14 • Number of events 3 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
45.5%
5/11 • Number of events 5 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
6.7%
1/15 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
14.3%
2/14 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
9.1%
1/11 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Vascular disorders
Flushing
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
14.3%
2/14 • Number of events 2 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/11 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
9.1%
1/11 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/31 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/30 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/15 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/10 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
0.00%
0/14 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
9.1%
1/11 • Number of events 1 • Solicited AEs collected days 1-8 for all cohorts, days 29-36 for cohort 4. Non-serious, unsolicited AEs collected Days 1-29 for all Cohorts, days 29-57 for Cohort 4. Serious AEs, AEs of special interest, new-onset chronic medical conditions, and all-cause mortality collected up to 14 months post baseline.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place