Trial Outcomes & Findings for Bivalent Norovirus Vaccine Study (NCT NCT01168401)
NCT ID: NCT01168401
Last Updated: 2018-11-23
Results Overview
The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfere with activity); Moderate (repeated use of non-narcotic pain reliever greater than (\>) 24 hours \[24h\] or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 centimeter \[cm\] and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (\>10 cm or prevented daily activity).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
102 participants
Primary outcome timeframe
Day 0 up to Day 7
Results posted on
2018-11-23
Participant Flow
Participants took part in the study at 3 investigative sites in the United States from 03 September 2010 to 09 January 2013.
Healthy volunteers were enrolled in 1 of the following treatment groups: Bivalent Norovirus GI.1/GII.4 Vaccine (Cohort A: 5/5 microgram \[mcg\], 15/15 mcg, 50/50 mcg, 150/150 mcg; Cohort B: 50/50 mcg; Cohort C: 50/50 mcg and Cohort D: 50/50 mcg) adjuvanted with 50 mcg monophosphoryl lipid A (MPL) and 500 mcg aluminum hydroxide \[Al(OH)3\]) or Placebo.
Participant milestones
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent Virus-Like Particle (VLP) Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9 percent \[%\] sodium chloride \[NaCl\] and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
9
|
9
|
9
|
10
|
10
|
9
|
8
|
8
|
|
Overall Study
COMPLETED
|
9
|
9
|
8
|
7
|
9
|
9
|
10
|
10
|
9
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Norovirus bivalent Virus-Like Particle (VLP) Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9 percent \[%\] sodium chloride \[NaCl\] and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Bivalent Norovirus Vaccine Study
Baseline characteristics by cohort
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=8 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Greater than or equal to (>=) 18 and <64 years
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
9 participants
n=7 Participants
|
9 participants
n=31 Participants
|
9 participants
n=30 Participants
|
10 participants
n=3 Participants
|
0 participants
n=6 Participants
|
0 participants
n=114 Participants
|
8 participants
|
8 participants
n=19 Participants
|
83 participants
n=4 Participants
|
|
Age, Customized
>=65 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=3 Participants
|
10 participants
n=6 Participants
|
9 participants
n=114 Participants
|
0 participants
|
0 participants
n=19 Participants
|
19 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
3 Participants
|
7 Participants
n=19 Participants
|
68 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
5 Participants
|
1 Participants
n=19 Participants
|
34 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
9 participants
n=7 Participants
|
9 participants
n=31 Participants
|
9 participants
n=30 Participants
|
10 participants
n=3 Participants
|
10 participants
n=6 Participants
|
9 participants
n=114 Participants
|
8 participants
|
8 participants
n=19 Participants
|
102 participants
n=4 Participants
|
|
Race
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
|
Race
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
4 Participants
n=4 Participants
|
|
Race
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
5 Participants
|
5 Participants
n=19 Participants
|
19 Participants
n=4 Participants
|
|
Race
White
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
9 Participants
n=114 Participants
|
3 Participants
|
2 Participants
n=19 Participants
|
76 Participants
n=4 Participants
|
|
Race
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity
Non-Hispanic
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
9 Participants
n=114 Participants
|
6 Participants
|
8 Participants
n=19 Participants
|
97 Participants
n=4 Participants
|
|
Ethnicity
Hispanic
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
2 Participants
|
0 Participants
n=19 Participants
|
5 Participants
n=4 Participants
|
|
Saliva Secretor Status
Saliva Secretor Status Positive
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
7 Participants
|
5 Participants
n=19 Participants
|
79 Participants
n=4 Participants
|
|
Saliva Secretor Status
Saliva Secretor Status Negative
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
1 Participants
|
3 Participants
n=19 Participants
|
23 Participants
n=4 Participants
|
|
Blood Type
Blood Type A
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
1 Participants
|
2 Participants
n=19 Participants
|
32 Participants
n=4 Participants
|
|
Blood Type
Blood Type B
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
2 Participants
|
2 Participants
n=19 Participants
|
11 Participants
n=4 Participants
|
|
Blood Type
Blood Type O
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
5 Participants
|
3 Participants
n=19 Participants
|
53 Participants
n=4 Participants
|
|
Blood Type
Blood Type AB
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Day 7Population: mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.
The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfere with activity); Moderate (repeated use of non-narcotic pain reliever greater than (\>) 24 hours \[24h\] or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 centimeter \[cm\] and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (\>10 cm or prevented daily activity).
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=8 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1
Pain: Mild
|
4 participants
|
5 participants
|
6 participants
|
5 participants
|
1 participants
|
5 participants
|
0 participants
|
4 participants
|
0 participants
|
4 participants
|
0 participants
|
|
Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1
Pain: Moderate
|
4 participants
|
2 participants
|
2 participants
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1
Tenderness: Mild
|
4 participants
|
5 participants
|
6 participants
|
5 participants
|
1 participants
|
4 participants
|
1 participants
|
6 participants
|
0 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1
Tenderness: Moderate
|
3 participants
|
4 participants
|
2 participants
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1
Swelling: Mild
|
1 participants
|
2 participants
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
3 participants
|
3 participants
|
PRIMARY outcome
Timeframe: Day 28 up to Day 35Population: mITT population where Day 28 to 35 assessment were available for this measure. mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.
The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfered with activity); Moderate (repeated use of non-narcotic pain reliever \>24h or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 cm and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (\>10 cm or prevented daily activity).
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=7 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=8 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=7 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local AEs Post Dose 2
Pain: Mild
|
5 participants
|
4 participants
|
4 participants
|
2 participants
|
0 participants
|
3 participants
|
0 participants
|
5 participants
|
0 participants
|
3 participants
|
1 participants
|
|
Number of Participants With Solicited Local AEs Post Dose 2
Pain: Moderate
|
3 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Solicited Local AEs Post Dose 2
Tenderness: Mild
|
7 participants
|
6 participants
|
6 participants
|
3 participants
|
1 participants
|
6 participants
|
1 participants
|
4 participants
|
0 participants
|
5 participants
|
2 participants
|
|
Number of Participants With Solicited Local AEs Post Dose 2
Tenderness: Moderate
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Local AEs Post Dose 2
Swelling: Mild
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
4 participants
|
5 participants
|
|
Number of Participants With Solicited Local AEs Post Dose 2
Swelling: Moderate
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Local AEs Post Dose 2
Redness: Mild
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 0 up to Day 7Population: mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.
Elevated oral temperature:Mild(38-38.4 Celsius\[C\]);Moderate(38.5-38.9 C);Severe(39-40 C).Headache:Mild(no interference with activity);Moderate(repeated use of non-narcotic pain reliever\>24h/some interference with activity);Severe(significant;any use of narcotic pain reliever/prevented daily activity).Fatigue,Malaise:Mild(no interference with activity);Moderate(some interference with activity);Severe(significant;prevented daily activity).Diarrhea:Mild(2-3loose stools/\<400gram\[g\]/24h);Moderate(4-5stools/400-800g/24h);Severe(\>=6watery stools/\>800g/24h/required intravenous\[IV\]hydration).Nausea/Vomiting:Mild(no interference with activity/1-2 episodes/24h);Moderate(some interference with activity/\>2 episodes/24h);Severe(prevented daily activity,required IV hydration).Muscle ache,chills,joint ache,abdominal cramp/pain:Mild(no interference with activity);Moderate(some interference with activity,not required medical intervention);Severe(prevented daily activity,required medical intervention).
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=8 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Headache: Mild
|
1 participants
|
3 participants
|
3 participants
|
2 participants
|
2 participants
|
5 participants
|
0 participants
|
2 participants
|
2 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Headache: Moderate
|
3 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Fatigue/ Malaise: Mild
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Fatigue/ Malaise: Moderate
|
4 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Muscle Aches : Mild
|
4 participants
|
2 participants
|
1 participants
|
3 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Muscle Aches : Moderate
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Joint Aches: Mild
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Joint Aches: Moderate
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Nausea: Mild
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Nausea: Moderate
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Abdominal Cramps/Discomfort: Mild
|
2 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Abdominal Cramps/Discomfort: Moderate
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Chills: Mild
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Chills: Moderate
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Vomiting: Moderate
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Diarrhea: Mild
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Diarrhea: Moderate
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 1
Diarrhea: Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 28 up to Day 35Population: mITT population where Day 28 to 35 assessment were available for this measure. mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.
Elevated oral temperature:Mild(38-38.4 C);Moderate(38.5-38.9 C);Severe(39-40 C).Headache:Mild(no interference with activity);Moderate(repeated use of non-narcotic pain reliever\>24h/some interference with activity);Severe(significant;any use of narcotic pain reliever/prevented daily activity).Fatigue,Malaise:Mild(no interference with activity);Moderate(some interference with activity);Severe(significant;prevented daily activity).Diarrhea:Mild(2-3loose stools/\<400g/24h);Moderate(4-5stools/400-800g/24h);Severe(\>=6watery stools/\>800g/24h/required IV hydration).Nausea/Vomiting:Mild(no interference with activity/1-2 episodes/24h);Moderate(some interference with activity/\>2 episodes/24h);Severe(prevented daily activity,required IV hydration).Muscle ache,chills,joint ache,abdominal cramp/pain:Mild(no interference with activity);Moderate(some interference with activity,not required medical intervention);Severe(prevented daily activity,required medical intervention).
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=7 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=8 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=7 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic AEs Post Dose 2
Muscle Aches: Moderate
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 2
Joint Aches: Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 2
Nausea: Mild
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 2
Abdominal Cramps/Discomfort: Mild
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 2
Chills: Mild
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 2
Diarrhea: Mild
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 2
Diarrhea: Severe
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 2
Nausea: Moderate
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 2
Headache: Mild
|
1 participants
|
1 participants
|
3 participants
|
2 participants
|
1 participants
|
3 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 2
Chills: Moderate
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 2
Headache: Moderate
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 2
Headache: Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 2
Fatigue/ Malaise: Mild
|
1 participants
|
0 participants
|
3 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 2
Fatigue/ Malaise: Moderate
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 2
Muscle Aches: Mild
|
2 participants
|
1 participants
|
3 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Systemic AEs Post Dose 2
Joint Aches: Mild
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 28 (Pre-dose 2)Population: mITT population included all participants who received at least 1 dose of study product.
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=8 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs Post Dose 1
|
7 participants
|
4 participants
|
4 participants
|
1 participants
|
2 participants
|
4 participants
|
0 participants
|
3 participants
|
3 participants
|
3 participants
|
4 participants
|
PRIMARY outcome
Timeframe: Day 28 up to Day 56 (Post dose 2)Population: mITT population where Day 28 to 56 assessment were available for this measure. mITT population included all participants who received at least 1 dose of study product.
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=7 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=8 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=7 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs Post Dose 2
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
2 participants
|
3 participants
|
3 participants
|
2 participants
|
2 participants
|
3 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 35Population: mITT population included all participants who received at least 1 dose of study product.
The number of participants with any markedly abnormal standard safety laboratory values (serum chemistry or hematology) collected throughout study.
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=8 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values
|
0 participants
|
3 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline up to 365 Days after post dose 2 (Day 393)Population: mITT population included all participants who received at least 1 dose of study product.
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=8 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI)
SAE
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI)
New Medical Conditions
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: First (I) run: predose 1 and 7, 21, 28 days postdose (PD)1, and 7 and 28 days PD2; second (II) run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)Population: Per Protocol (PP) population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=7 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GI.1: I Run:21 Days PD1
|
164 titer
Interval 87.0 to 311.0
|
164 titer
Interval 71.0 to 379.0
|
269 titer
Interval 90.0 to 799.0
|
307 titer
Interval 84.0 to 1115.0
|
9 titer
Interval 3.0 to 26.0
|
252 titer
Interval 151.0 to 421.0
|
5 titer
Interval 3.0 to 9.0
|
114 titer
Interval 31.0 to 423.0
|
4 titer
Interval 3.0 to 5.0
|
31 titer
Interval 10.0 to 96.0
|
3 titer
Confidence interval could not be calculated because there was no variance in the observed data.
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GI.1: I Run:28 Days PD1
|
143 titer
Interval 70.0 to 293.0
|
106 titer
Interval 42.0 to 267.0
|
183 titer
Interval 61.0 to 544.0
|
149 titer
Interval 43.0 to 517.0
|
9 titer
Interval 3.0 to 23.0
|
178 titer
Interval 95.0 to 335.0
|
5 titer
Interval 3.0 to 8.0
|
104 titer
Interval 29.0 to 375.0
|
4 titer
Interval 3.0 to 5.0
|
21 titer
Interval 7.0 to 60.0
|
3 titer
Confidence interval could not be calculated because there was no variance in the observed data.
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GI.1: I Run:7 Days PD2
|
134 titer
Interval 62.0 to 291.0
|
112 titer
Interval 46.0 to 275.0
|
130 titer
Interval 57.0 to 294.0
|
131 titer
Interval 45.0 to 376.0
|
11 titer
Interval 3.0 to 34.0
|
140 titer
Interval 73.0 to 270.0
|
5 titer
Interval 3.0 to 8.0
|
105 titer
Interval 33.0 to 329.0
|
4 titer
Interval 3.0 to 5.0
|
19 titer
Interval 7.0 to 55.0
|
3 titer
Confidence interval could not be calculated because there was no variance in the observed data.
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GI.1: II Run:28 Days PD2
|
32 titer
Interval 13.0 to 81.0
|
15 titer
Interval 7.0 to 33.0
|
11 titer
Interval 6.0 to 21.0
|
16 titer
Interval 6.0 to 43.0
|
6 titer
Interval 2.0 to 18.0
|
120 titer
Interval 62.0 to 231.0
|
6 titer
Interval 3.0 to 11.0
|
154 titer
Interval 68.0 to 348.0
|
5 titer
Interval 3.0 to 8.0
|
35 titer
Interval 13.0 to 99.0
|
3 titer
Interval 3.0 to 5.0
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GII.4: I Run:7 Days PD2
|
108 titer
Interval 73.0 to 160.0
|
94 titer
Interval 44.0 to 202.0
|
17 titer
Interval 6.0 to 48.0
|
22 titer
Interval 10.0 to 50.0
|
29 titer
Interval 12.0 to 72.0
|
44 titer
Interval 12.0 to 159.0
|
5 titer
Interval 3.0 to 8.0
|
22 titer
Interval 9.0 to 55.0
|
7 titer
Interval 3.0 to 14.0
|
36 titer
Interval 15.0 to 89.0
|
6 titer
Interval 3.0 to 11.0
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GI.1: I Run: Pre-Dose 1
|
9 titer
Interval 3.0 to 26.0
|
5 titer
Interval 3.0 to 7.0
|
5 titer
Interval 3.0 to 10.0
|
6 titer
Interval 3.0 to 13.0
|
10 titer
Interval 3.0 to 32.0
|
3 titer
Confidence interval could not be calculated because there was no variance in the observed data.
|
5 titer
Interval 3.0 to 8.0
|
5 titer
Interval 3.0 to 9.0
|
4 titer
Interval 3.0 to 5.0
|
3 titer
Interval 3.0 to 3.0
|
3 titer
Confidence interval could not be calculated because there was no variance in the observed data.
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GI.1: I Run:7 Days PD1
|
204 titer
Interval 126.0 to 332.0
|
357 titer
Interval 141.0 to 906.0
|
458 titer
Interval 97.0 to 2154.0
|
675 titer
Interval 136.0 to 3334.0
|
7 titer
Interval 2.0 to 20.0
|
357 titer
Interval 110.0 to 1158.0
|
5 titer
Interval 3.0 to 8.0
|
208 titer
Interval 48.0 to 903.0
|
4 titer
Interval 3.0 to 5.0
|
40 titer
Interval 13.0 to 120.0
|
3 titer
Confidence interval could not be calculated because there was no variance in the observed data.
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GI.1: I Run:28 Days PD2
|
115 titer
Interval 55.0 to 243.0
|
80 titer
Interval 28.0 to 224.0
|
70 titer
Interval 24.0 to 202.0
|
78 titer
Interval 20.0 to 310.0
|
10 titer
Interval 3.0 to 29.0
|
97 titer
Interval 48.0 to 198.0
|
5 titer
Interval 3.0 to 8.0
|
76 titer
Interval 23.0 to 251.0
|
4 titer
Interval 3.0 to 5.0
|
17 titer
Interval 7.0 to 42.0
|
3 titer
Confidence interval could not be calculated because there was no variance in the observed data.
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GI.1: II Run:Pre-Dose 1
|
5 titer
Interval 2.0 to 9.0
|
3 titer
Confidence interval could not be calculated because there was no variance in the observed data.
|
3 titer
Confidence interval could not be calculated because there was no variance in the observed data.
|
3 titer
Interval 3.0 to 4.0
|
6 titer
Interval 2.0 to 18.0
|
3 titer
Confidence interval could not be calculated because there was no variance in the observed data.
|
6 titer
Interval 3.0 to 12.0
|
6 titer
Interval 3.0 to 13.0
|
5 titer
Interval 3.0 to 9.0
|
4 titer
Interval 2.0 to 6.0
|
3 titer
Confidence interval could not be calculated because there was no variance in the observed data.
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GI.1: II Run:152 Days PD2
|
17 titer
Interval 6.0 to 47.0
|
13 titer
Interval 6.0 to 26.0
|
10 titer
Interval 6.0 to 19.0
|
16 titer
Interval 6.0 to 43.0
|
6 titer
Interval 2.0 to 18.0
|
57 titer
Interval 36.0 to 92.0
|
6 titer
Interval 3.0 to 12.0
|
78 titer
Interval 42.0 to 143.0
|
6 titer
Interval 4.0 to 10.0
|
24 titer
Interval 10.0 to 58.0
|
3 titer
Interval 3.0 to 4.0
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GI.1: II Run:365 Days PD2
|
23 titer
Interval 6.0 to 92.0
|
11 titer
Interval 6.0 to 22.0
|
8 titer
Interval 5.0 to 14.0
|
14 titer
Interval 4.0 to 44.0
|
5 titer
Interval 2.0 to 13.0
|
38 titer
Interval 22.0 to 65.0
|
6 titer
Interval 3.0 to 12.0
|
53 titer
Interval 29.0 to 99.0
|
7 titer
Interval 4.0 to 13.0
|
16 titer
Interval 7.0 to 39.0
|
3 titer
Confidence interval could not be calculated because there was no variance in the observed data.
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GII.4: I Run: Pre-Dose 1
|
21 titer
Interval 7.0 to 63.0
|
13 titer
Interval 5.0 to 34.0
|
5 titer
Interval 2.0 to 12.0
|
9 titer
Interval 4.0 to 20.0
|
23 titer
Interval 7.0 to 70.0
|
9 titer
Interval 3.0 to 29.0
|
5 titer
Interval 3.0 to 7.0
|
9 titer
Interval 4.0 to 23.0
|
6 titer
Interval 3.0 to 12.0
|
5 titer
Interval 2.0 to 9.0
|
6 titer
Interval 3.0 to 12.0
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GII.4: I Run:7 Days PD1
|
140 titer
Interval 92.0 to 213.0
|
193 titer
Interval 87.0 to 432.0
|
57 titer
Interval 24.0 to 138.0
|
52 titer
Interval 35.0 to 78.0
|
18 titer
Interval 6.0 to 53.0
|
92 titer
Interval 26.0 to 322.0
|
5 titer
Interval 3.0 to 8.0
|
41 titer
Interval 26.0 to 65.0
|
7 titer
Interval 3.0 to 14.0
|
96 titer
Interval 22.0 to 421.0
|
6 titer
Interval 3.0 to 13.0
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GII.4: I Run:21 Days PD1
|
120 titer
Interval 95.0 to 151.0
|
113 titer
Interval 53.0 to 239.0
|
27 titer
Interval 8.0 to 93.0
|
25 titer
Interval 14.0 to 42.0
|
16 titer
Interval 6.0 to 45.0
|
63 titer
Interval 21.0 to 186.0
|
5 titer
Interval 3.0 to 9.0
|
25 titer
Interval 9.0 to 70.0
|
7 titer
Interval 3.0 to 16.0
|
55 titer
Interval 18.0 to 170.0
|
6 titer
Interval 3.0 to 13.0
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GII.4: I Run:28 Days PD1
|
116 titer
Interval 84.0 to 161.0
|
68 titer
Interval 32.0 to 149.0
|
19 titer
Interval 6.0 to 61.0
|
19 titer
Interval 10.0 to 34.0
|
19 titer
Interval 7.0 to 48.0
|
42 titer
Interval 11.0 to 159.0
|
5 titer
Interval 3.0 to 7.0
|
22 titer
Interval 9.0 to 55.0
|
6 titer
Interval 3.0 to 12.0
|
39 titer
Interval 15.0 to 100.0
|
6 titer
Interval 3.0 to 12.0
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GII.4: I Run:28 Days PD2
|
108 titer
Interval 79.0 to 149.0
|
76 titer
Interval 36.0 to 174.0
|
19 titer
Interval 7.0 to 54.0
|
19 titer
Interval 9.0 to 39.0
|
30 titer
Interval 12.0 to 76.0
|
34 titer
Interval 10.0 to 117.0
|
5 titer
Interval 3.0 to 7.0
|
21 titer
Interval 9.0 to 53.0
|
6 titer
Interval 3.0 to 14.0
|
31 titer
Interval 13.0 to 73.0
|
6 titer
Interval 3.0 to 13.0
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GII.4: II Run:Pre-Dose 1
|
8 titer
Interval 4.0 to 17.0
|
4 titer
Interval 2.0 to 7.0
|
4 titer
Interval 2.0 to 11.0
|
8 titer
Interval 4.0 to 17.0
|
5 titer
Interval 2.0 to 10.0
|
9 titer
Interval 3.0 to 28.0
|
5 titer
Interval 3.0 to 8.0
|
18 titer
Interval 5.0 to 66.0
|
8 titer
Interval 4.0 to 17.0
|
5 titer
Interval 2.0 to 12.0
|
7 titer
Interval 3.0 to 16.0
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GII.4: II Run:28 Days PD2
|
39 titer
Interval 22.0 to 71.0
|
32 titer
Interval 17.0 to 60.0
|
17 titer
Interval 7.0 to 42.0
|
19 titer
Interval 12.0 to 31.0
|
7 titer
Interval 3.0 to 20.0
|
38 titer
Interval 11.0 to 125.0
|
5 titer
Interval 3.0 to 9.0
|
44 titer
Interval 13.0 to 144.0
|
8 titer
Interval 4.0 to 19.0
|
42 titer
Interval 20.0 to 89.0
|
7 titer
Interval 3.0 to 16.0
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GII.4: II Run:152 Days PD2
|
25 titer
Interval 11.0 to 54.0
|
20 titer
Interval 9.0 to 44.0
|
9 titer
Interval 4.0 to 23.0
|
14 titer
Interval 7.0 to 28.0
|
6 titer
Interval 3.0 to 15.0
|
27 titer
Interval 9.0 to 83.0
|
6 titer
Interval 3.0 to 11.0
|
29 titer
Interval 10.0 to 85.0
|
9 titer
Interval 4.0 to 19.0
|
25 titer
Interval 10.0 to 65.0
|
6 titer
Interval 3.0 to 13.0
|
|
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
GII.4: II Run:365 Days PD2
|
16 titer
Interval 5.0 to 45.0
|
13 titer
Interval 5.0 to 38.0
|
8 titer
Interval 3.0 to 22.0
|
16 titer
Interval 9.0 to 29.0
|
6 titer
Interval 3.0 to 11.0
|
17 titer
Interval 5.0 to 56.0
|
7 titer
Interval 3.0 to 18.0
|
24 titer
Interval 9.0 to 66.0
|
11 titer
Interval 4.0 to 28.0
|
19 titer
Interval 7.0 to 47.0
|
6 titer
Interval 3.0 to 13.0
|
SECONDARY outcome
Timeframe: I run: predose 1 and 7, 21, 28 days PD1, and 7 and 28 days PD2; II run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)Population: PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=7 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: I Run:7 Days PD2
|
281 titer
Interval 152.0 to 520.0
|
167 titer
Interval 77.0 to 365.0
|
723 titer
Interval 360.0 to 1452.0
|
957 titer
Interval 554.0 to 1651.0
|
10 titer
Interval 2.0 to 49.0
|
513 titer
Interval 249.0 to 1060.0
|
7 titer
Interval 3.0 to 21.0
|
157 titer
Interval 66.0 to 373.0
|
10 titer
Interval 4.0 to 24.0
|
108 titer
Interval 25.0 to 474.0
|
5 titer
Interval 2.0 to 14.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: II Run:Pre-Dose 1
|
5 titer
Interval 2.0 to 14.0
|
7 titer
Interval 3.0 to 14.0
|
5 titer
Interval 3.0 to 8.0
|
5 titer
Interval 2.0 to 10.0
|
7 titer
Interval 2.0 to 27.0
|
8 titer
Interval 4.0 to 19.0
|
7 titer
Interval 3.0 to 14.0
|
9 titer
Interval 3.0 to 30.0
|
8 titer
Interval 4.0 to 18.0
|
3 titer
Interval 1.0 to 6.0
|
3 titer
Interval 1.0 to 5.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: I Run: Pre-Dose 1
|
38 titer
Interval 10.0 to 142.0
|
19 titer
Interval 6.0 to 62.0
|
5 titer
Interval 2.0 to 14.0
|
17 titer
Interval 7.0 to 41.0
|
19 titer
Interval 5.0 to 69.0
|
8 titer
Interval 2.0 to 29.0
|
5 titer
Interval 2.0 to 15.0
|
10 titer
Interval 4.0 to 28.0
|
6 titer
Interval 2.0 to 20.0
|
11 titer
Interval 5.0 to 22.0
|
13 titer
Interval 4.0 to 45.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: I Run:7 Days PD1
|
97 titer
Interval 56.0 to 167.0
|
136 titer
Interval 66.0 to 279.0
|
43 titer
Interval 30.0 to 62.0
|
40 titer
Interval 27.0 to 60.0
|
14 titer
Interval 4.0 to 53.0
|
54 titer
Interval 14.0 to 206.0
|
5 titer
Interval 2.0 to 15.0
|
23 titer
Interval 14.0 to 37.0
|
9 titer
Interval 3.0 to 24.0
|
178 titer
Interval 100.0 to 317.0
|
16 titer
Interval 6.0 to 46.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: I Run:28 Days PD1
|
139 titer
Interval 73.0 to 267.0
|
98 titer
Interval 42.0 to 225.0
|
31 titer
Interval 22.0 to 45.0
|
37 titer
Interval 28.0 to 49.0
|
16 titer
Interval 6.0 to 46.0
|
86 titer
Interval 31.0 to 237.0
|
5 titer
Interval 2.0 to 13.0
|
30 titer
Interval 20.0 to 45.0
|
7 titer
Interval 2.0 to 20.0
|
148 titer
Interval 105.0 to 208.0
|
16 titer
Interval 6.0 to 45.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: I Run:7 Days PD2
|
144 titer
Interval 72.0 to 288.0
|
132 titer
Interval 71.0 to 248.0
|
34 titer
Interval 28.0 to 42.0
|
42 titer
Interval 34.0 to 51.0
|
25 titer
Interval 9.0 to 69.0
|
99 titer
Interval 42.0 to 233.0
|
5 titer
Interval 2.0 to 14.0
|
34 titer
Interval 25.0 to 45.0
|
8 titer
Interval 3.0 to 24.0
|
144 titer
Interval 106.0 to 196.0
|
15 titer
Interval 5.0 to 46.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: I Run:7 Days PD1
|
211 titer
Interval 98.0 to 452.0
|
237 titer
Interval 120.0 to 466.0
|
1650 titer
Interval 673.0 to 4047.0
|
1171 titer
Interval 251.0 to 5457.0
|
5 titer
Interval 1.0 to 20.0
|
375 titer
Interval 97.0 to 1447.0
|
7 titer
Interval 2.0 to 19.0
|
96 titer
Interval 32.0 to 289.0
|
10 titer
Interval 4.0 to 24.0
|
82 titer
Interval 18.0 to 373.0
|
5 titer
Interval 1.0 to 16.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: I Run:21 Days PD1
|
266 titer
Interval 130.0 to 545.0
|
184 titer
Interval 93.0 to 363.0
|
1165 titer
Interval 495.0 to 2741.0
|
1235 titer
Interval 534.0 to 2858.0
|
7 titer
Interval 2.0 to 26.0
|
457 titer
Interval 159.0 to 1312.0
|
5 titer
Interval 1.0 to 18.0
|
97 titer
Interval 30.0 to 309.0
|
13 titer
Interval 5.0 to 30.0
|
107 titer
Interval 24.0 to 468.0
|
5 titer
Interval 1.0 to 14.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: I Run:28 Days PD1
|
261 titer
Interval 140.0 to 486.0
|
152 titer
Interval 76.0 to 305.0
|
910 titer
Interval 379.0 to 2185.0
|
878 titer
Interval 409.0 to 1882.0
|
7 titer
Interval 2.0 to 26.0
|
429 titer
Interval 178.0 to 1036.0
|
6 titer
Interval 2.0 to 18.0
|
110 titer
Interval 41.0 to 300.0
|
10 titer
Interval 4.0 to 23.0
|
93 titer
Interval 22.0 to 395.0
|
5 titer
Interval 2.0 to 16.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: I Run:28 Days PD2
|
286 titer
Interval 151.0 to 540.0
|
168 titer
Interval 76.0 to 346.0
|
605 titer
Interval 256.0 to 1432.0
|
737 titer
Interval 399.0 to 1361.0
|
11 titer
Interval 2.0 to 50.0
|
518 titer
Interval 278.0 to 966.0
|
6 titer
Interval 2.0 to 19.0
|
177 titer
Interval 78.0 to 399.0
|
10 titer
Interval 4.0 to 26.0
|
127 titer
Interval 27.0 to 586.0
|
5 titer
Interval 2.0 to 16.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: I Run: Pre-Dose 1
|
13 titer
Interval 3.0 to 55.0
|
8 titer
Interval 2.0 to 27.0
|
28 titer
Interval 11.0 to 73.0
|
22 titer
Interval 7.0 to 68.0
|
9 titer
Interval 2.0 to 37.0
|
9 titer
Interval 3.0 to 26.0
|
7 titer
Interval 3.0 to 21.0
|
14 titer
Interval 5.0 to 38.0
|
11 titer
Interval 4.0 to 26.0
|
7 titer
Interval 2.0 to 32.0
|
5 titer
Interval 1.0 to 14.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: II Run:28 Days PD2
|
83 titer
Interval 45.0 to 156.0
|
94 titer
Interval 46.0 to 192.0
|
89 titer
Interval 44.0 to 181.0
|
113 titer
Interval 78.0 to 164.0
|
10 titer
Interval 3.0 to 36.0
|
270 titer
Interval 178.0 to 411.0
|
6 titer
Interval 2.0 to 14.0
|
103 titer
Interval 53.0 to 200.0
|
8 titer
Interval 4.0 to 17.0
|
80 titer
Interval 56.0 to 116.0
|
3 titer
Interval 1.0 to 6.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: II Run:152 Days PD2
|
44 titer
Interval 22.0 to 91.0
|
65 titer
Interval 43.0 to 99.0
|
46 titer
Interval 24.0 to 89.0
|
73 titer
Interval 45.0 to 118.0
|
8 titer
Interval 2.0 to 28.0
|
135 titer
Interval 90.0 to 202.0
|
7 titer
Interval 3.0 to 16.0
|
82 titer
Interval 47.0 to 143.0
|
8 titer
Interval 4.0 to 17.0
|
35 titer
Interval 27.0 to 44.0
|
3 titer
Interval 1.0 to 5.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: II Run:365 Days PD2
|
58 titer
Interval 26.0 to 131.0
|
53 titer
Interval 40.0 to 68.0
|
28 titer
Interval 15.0 to 54.0
|
46 titer
Interval 23.0 to 92.0
|
6 titer
Interval 2.0 to 19.0
|
75 titer
Interval 55.0 to 103.0
|
6 titer
Interval 2.0 to 16.0
|
57 titer
Interval 33.0 to 99.0
|
10 titer
Interval 4.0 to 28.0
|
21 titer
Interval 13.0 to 34.0
|
3 titer
Interval 1.0 to 6.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: I Run:21 Days PD1
|
142 titer
Interval 70.0 to 286.0
|
128 titer
Interval 59.0 to 279.0
|
35 titer
Interval 25.0 to 50.0
|
39 titer
Interval 27.0 to 55.0
|
13 titer
Interval 4.0 to 45.0
|
93 titer
Interval 33.0 to 262.0
|
5 titer
Interval 2.0 to 15.0
|
29 titer
Interval 17.0 to 49.0
|
9 titer
Interval 3.0 to 28.0
|
180 titer
Interval 126.0 to 259.0
|
17 titer
Interval 6.0 to 48.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: I Run:28 Days PD2
|
174 titer
Interval 90.0 to 336.0
|
125 titer
Interval 72.0 to 218.0
|
34 titer
Interval 26.0 to 46.0
|
41 titer
Interval 32.0 to 51.0
|
27 titer
Interval 10.0 to 75.0
|
102 titer
Interval 43.0 to 242.0
|
6 titer
Interval 2.0 to 15.0
|
36 titer
Interval 28.0 to 47.0
|
7 titer
Interval 3.0 to 21.0
|
140 titer
Interval 97.0 to 202.0
|
17 titer
Interval 6.0 to 49.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: II Run:Pre-Dose 1
|
13 titer
Interval 5.0 to 31.0
|
11 titer
Interval 4.0 to 32.0
|
5 titer
Interval 2.0 to 13.0
|
10 titer
Interval 3.0 to 33.0
|
5 titer
Interval 2.0 to 14.0
|
6 titer
Interval 2.0 to 18.0
|
4 titer
Interval 2.0 to 9.0
|
9 titer
Interval 2.0 to 42.0
|
7 titer
Interval 2.0 to 20.0
|
3 titer
Interval 1.0 to 7.0
|
6 titer
Interval 2.0 to 14.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: II Run:28 Days PD2
|
65 titer
Interval 39.0 to 106.0
|
74 titer
Interval 46.0 to 120.0
|
57 titer
Interval 35.0 to 91.0
|
37 titer
Interval 18.0 to 73.0
|
8 titer
Interval 2.0 to 34.0
|
104 titer
Interval 65.0 to 166.0
|
5 titer
Interval 2.0 to 12.0
|
52 titer
Interval 22.0 to 120.0
|
7 titer
Interval 2.0 to 18.0
|
37 titer
Interval 25.0 to 56.0
|
6 titer
Interval 2.0 to 15.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: II Run:152 Days PD2
|
52 titer
Interval 31.0 to 87.0
|
44 titer
Interval 22.0 to 91.0
|
18 titer
Interval 8.0 to 41.0
|
18 titer
Interval 9.0 to 36.0
|
7 titer
Interval 2.0 to 23.0
|
77 titer
Interval 30.0 to 194.0
|
5 titer
Interval 2.0 to 11.0
|
33 titer
Interval 14.0 to 75.0
|
8 titer
Interval 2.0 to 26.0
|
20 titer
Interval 12.0 to 33.0
|
5 titer
Interval 2.0 to 12.0
|
|
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: II Run:365 Days PD2
|
28 titer
Interval 11.0 to 75.0
|
51 titer
Interval 27.0 to 96.0
|
13 titer
Interval 7.0 to 25.0
|
23 titer
Interval 11.0 to 51.0
|
6 titer
Interval 2.0 to 16.0
|
44 titer
Interval 24.0 to 81.0
|
6 titer
Interval 2.0 to 16.0
|
22 titer
Interval 9.0 to 54.0
|
13 titer
Interval 5.0 to 34.0
|
16 titer
Interval 8.0 to 34.0
|
5 titer
Interval 2.0 to 12.0
|
SECONDARY outcome
Timeframe: I run: predose 1 and 7, 21, 28 days PD1, and 7 and 28 days PD2; II run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)Population: Data was not collected because serum specimens were not tested for specific IgM antibodies to Norovirus GI.1 and GII.4 VLPs as per the change in planned analysis, because this measurement was not informative in a previous study LV01-103 (NCT00973284).
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)Population: PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=8 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=7 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
GI.1: I Run:7 Days PD2
|
15.1 fold rise
Interval 6.2 to 37.0
|
22.5 fold rise
Interval 11.8 to 42.9
|
23.9 fold rise
Interval 9.6 to 59.7
|
22.2 fold rise
Interval 10.8 to 45.4
|
1.1 fold rise
Interval 0.7 to 1.6
|
45.2 fold rise
Interval 23.4 to 87.2
|
1 fold rise
Interval 1.0 to 1.1
|
19.7 fold rise
Interval 7.3 to 53.2
|
1 fold rise
Interval 0.9 to 1.0
|
6 fold rise
Interval 2.1 to 17.3
|
1 fold rise
Confidence interval could not be calculated because there was no variance in the observed data.
|
|
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
GII.4: I Run:7 Days PD1
|
6.7 fold rise
Interval 2.2 to 20.7
|
15.4 fold rise
Interval 4.7 to 50.8
|
10.7 fold rise
Interval 3.5 to 32.9
|
5 fold rise
Interval 2.2 to 11.0
|
1 fold rise
Interval 0.9 to 1.1
|
9.7 fold rise
Interval 3.0 to 30.6
|
1 fold rise
Interval 1.0 to 1.1
|
4.4 fold rise
Interval 2.1 to 9.6
|
1.2 fold rise
Interval 0.9 to 1.4
|
19.9 fold rise
Interval 5.9 to 67.6
|
1 fold rise
Interval 1.0 to 1.1
|
|
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
GII.4: I Run:7 Days PD2
|
5.2 fold rise
Interval 2.1 to 12.6
|
6.1 fold rise
Interval 2.9 to 12.7
|
3.2 fold rise
Interval 1.1 to 9.4
|
2.5 fold rise
Interval 1.0 to 5.9
|
1.3 fold rise
Interval 0.4 to 3.6
|
4.6 fold rise
Interval 2.1 to 10.3
|
1.1 fold rise
Interval 1.0 to 1.1
|
2.4 fold rise
Interval 0.9 to 6.3
|
1.1 fold rise
Interval 0.9 to 1.5
|
7.5 fold rise
Interval 3.0 to 18.6
|
1 fold rise
Interval 0.8 to 1.1
|
|
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
GII.4: I Run:28 Days PD2
|
5.2 fold rise
Interval 2.1 to 12.6
|
5.2 fold rise
Interval 2.6 to 10.2
|
3.4 fold rise
Interval 1.4 to 8.4
|
2 fold rise
Interval 1.0 to 4.4
|
1.3 fold rise
Interval 0.5 to 3.3
|
3.5 fold rise
Interval 1.7 to 7.4
|
1 fold rise
Interval 1.0 to 1.1
|
2.3 fold rise
Interval 1.0 to 5.7
|
1.1 fold rise
Interval 0.9 to 1.4
|
6.4 fold rise
Interval 2.6 to 15.6
|
1.1 fold rise
Interval 1.0 to 1.2
|
|
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
GII.4: II Run:152 Days PD2
|
2.6 fold rise
Interval 1.8 to 3.9
|
4.8 fold rise
Interval 2.4 to 9.4
|
2 fold rise
Interval 1.0 to 4.0
|
1.9 fold rise
Interval 0.8 to 4.5
|
1.3 fold rise
Interval 0.7 to 2.4
|
2.8 fold rise
Interval 1.5 to 5.2
|
1.2 fold rise
Interval 0.9 to 1.6
|
1.6 fold rise
Interval 0.5 to 4.8
|
1.1 fold rise
Interval 0.9 to 1.4
|
4.8 fold rise
Interval 1.8 to 12.7
|
0.8 fold rise
Interval 0.6 to 1.2
|
|
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
GII.4: II Run:365 Days PD2
|
2 fold rise
Interval 1.2 to 3.2
|
3.1 fold rise
Interval 1.3 to 7.3
|
1.7 fold rise
Interval 0.9 to 3.5
|
1.8 fold rise
Interval 0.8 to 4.2
|
1.3 fold rise
Interval 0.8 to 2.1
|
1.8 fold rise
Interval 0.9 to 3.6
|
1.5 fold rise
Interval 0.9 to 2.6
|
1.3 fold rise
Interval 0.4 to 4.1
|
1.4 fold rise
Interval 0.8 to 2.3
|
4.4 fold rise
Interval 1.6 to 12.0
|
0.8 fold rise
Interval 0.6 to 1.1
|
|
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
GI.1: I Run:28 Days PD1
|
16.2 fold rise
Interval 6.1 to 42.8
|
22.6 fold rise
Interval 11.1 to 46.0
|
33.7 fold rise
Interval 11.7 to 46.0
|
25.4 fold rise
Interval 10.5 to 61.3
|
1 fold rise
Interval 0.8 to 1.2
|
57.5 fold rise
Interval 30.6 to 108.0
|
1 fold rise
Interval 0.9 to 1.1
|
19.6 fold rise
Interval 6.4 to 60.5
|
1 fold rise
Interval 0.9 to 1.0
|
6.6 fold rise
Interval 2.4 to 18.8
|
1 fold rise
Confidence interval could not be calculated because there was no variance in the observed data.
|
|
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
GII.4: I Run:21 Days PD1
|
5.7 fold rise
Interval 2.0 to 16.5
|
9 fold rise
Interval 4.1 to 20.0
|
5 fold rise
Interval 1.3 to 18.9
|
2.7 fold rise
Interval 1.3 to 5.5
|
0.9 fold rise
Interval 0.7 to 1.0
|
6.6 fold rise
Interval 3.0 to 14.4
|
1.1 fold rise
Interval 0.9 to 1.2
|
3.5 fold rise
Interval 1.2 to 9.7
|
1.1 fold rise
Interval 0.8 to 1.6
|
11.4 fold rise
Interval 3.9 to 33.3
|
1 fold rise
Interval 1.0 to 1.1
|
|
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
GII.4: I Run:28 Days PD1
|
5.6 fold rise
Interval 2.1 to 14.8
|
5.5 fold rise
Interval 2.4 to 12.3
|
3.6 fold rise
Interval 1.1 to 12.0
|
2 fold rise
Interval 1.0 to 4.3
|
1 fold rise
Interval 0.6 to 1.9
|
4.5 fold rise
Interval 1.9 to 10.7
|
1 fold rise
Interval 0.9 to 1.1
|
2.4 fold rise
Interval 0.9 to 6.4
|
1 fold rise
Interval 0.8 to 1.2
|
8.1 fold rise
Interval 3.2 to 20.4
|
1 fold rise
Interval 0.9 to 1.1
|
|
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
GII.4: II Run:28 Days PD2
|
4.7 fold rise
Interval 2.9 to 7.7
|
7.5 fold rise
Interval 4.6 to 12.2
|
3.9 fold rise
Interval 1.6 to 9.1
|
2.5 fold rise
Interval 1.0 to 5.9
|
1.5 fold rise
Interval 0.6 to 3.6
|
4 fold rise
Interval 1.9 to 8.3
|
1.1 fold rise
Interval 0.9 to 1.4
|
2.4 fold rise
Interval 0.8 to 7.2
|
1 fold rise
Interval 0.9 to 1.2
|
8.1 fold rise
Interval 3.2 to 20.4
|
1 fold rise
Interval 0.9 to 1.0
|
|
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
GI.1: I Run:7 Days PD1
|
23.1 fold rise
Interval 7.4 to 71.9
|
76.1 fold rise
Interval 38.1 to 152.0
|
84.4 fold rise
Interval 20.6 to 345.1
|
122.9 fold rise
Interval 30.0 to 503.7
|
0.8 fold rise
Interval 0.3 to 1.8
|
115.2 fold rise
Interval 35.5 to 373.7
|
1 fold rise
Interval 1.0 to 1.0
|
39.1 fold rise
Interval 10.3 to 148.2
|
1 fold rise
Interval 1.0 to 1.0
|
12.6 fold rise
Interval 4.2 to 37.6
|
1 fold rise
Confidence interval could not be calculated because there was no variance in the observed data.
|
|
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
GI.1: I Run:21 Days PD1
|
18.5 fold rise
Interval 7.0 to 49.0
|
34.9 fold rise
Interval 16.6 to 73.4
|
49.6 fold rise
Interval 18.2 to 134.9
|
52.1 fold rise
Interval 19.3 to 140.4
|
1 fold rise
Interval 0.9 to 1.2
|
81.2 fold rise
Interval 48.6 to 135.7
|
1 fold rise
Interval 0.9 to 1.1
|
24.2 fold rise
Interval 6.9 to 85.7
|
1 fold rise
Interval 0.9 to 1.0
|
9.7 fold rise
Interval 3.1 to 30.2
|
1 fold rise
Confidence interval could not be calculated because there was no variance in the observed data.
|
|
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
GI.1: I Run:28 Days PD2
|
13 fold rise
Interval 5.0 to 33.6
|
16 fold rise
Interval 7.4 to 34.5
|
12.1 fold rise
Interval 4.8 to 30.7
|
13.2 fold rise
Interval 5.0 to 34.7
|
1 fold rise
Interval 0.7 to 1.3
|
31.3 fold rise
Interval 15.4 to 63.7
|
1.1 fold rise
Interval 0.9 to 1.3
|
14.2 fold rise
Interval 5.1 to 39.8
|
1 fold rise
Interval 1.0 to 1.1
|
5.3 fold rise
Interval 2.1 to 13.1
|
1 fold rise
Confidence interval could not be calculated because there was no variance in the observed data.
|
|
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
GI.1: II Run:28 Days PD2
|
7 fold rise
Interval 3.7 to 13.3
|
5 fold rise
Interval 2.3 to 10.7
|
3.6 fold rise
Interval 1.9 to 6.8
|
4.7 fold rise
Interval 1.9 to 11.7
|
1 fold rise
Interval 1.0 to 1.0
|
38.6 fold rise
Interval 19.9 to 74.6
|
1 fold rise
Interval 0.9 to 1.1
|
25.5 fold rise
Interval 9.1 to 71.4
|
1 fold rise
Interval 1.0 to 1.0
|
9.6 fold rise
Interval 3.7 to 24.9
|
1.1 fold rise
Interval 0.9 to 1.5
|
|
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
GI.1: II Run:152 Days PD2
|
3.6 fold rise
Interval 1.8 to 7.1
|
4.1 fold rise
Interval 2.0 to 8.3
|
3.3 fold rise
Interval 1.8 to 6.0
|
4.6 fold rise
Interval 1.7 to 12.0
|
1 fold rise
Interval 1.0 to 1.0
|
18.5 fold rise
Interval 11.5 to 29.8
|
1.1 fold rise
Interval 0.9 to 1.3
|
12.9 fold rise
Interval 5.5 to 30.0
|
1.1 fold rise
Interval 0.9 to 1.3
|
6.6 fold rise
Interval 2.9 to 15.1
|
1.1 fold rise
Interval 0.9 to 1.4
|
|
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
GI.1: II Run:365 Days PD2
|
4.1 fold rise
Interval 1.3 to 13.5
|
3.7 fold rise
Interval 1.9 to 7.1
|
2.6 fold rise
Interval 1.6 to 4.4
|
4.5 fold rise
Interval 1.4 to 14.1
|
1 fold rise
Interval 0.9 to 1.0
|
12.2 fold rise
Interval 7.1 to 20.9
|
1 fold rise
Interval 0.9 to 1.2
|
8.8 fold rise
Interval 3.9 to 20.2
|
1.3 fold rise
Interval 0.9 to 1.9
|
5.2 fold rise
Interval 2.1 to 12.7
|
1 fold rise
Confidence interval could not be calculated because there was no variance in the observed data.
|
SECONDARY outcome
Timeframe: I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)Population: PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=8 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=7 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
GI.1: I Run:28 Days PD1
|
20 fold rise
Interval 4.9 to 81.6
|
18.9 fold rise
Interval 6.8 to 52.6
|
32.8 fold rise
Interval 18.2 to 59.2
|
39.2 fold rise
Interval 17.6 to 87.6
|
1 fold rise
Interval 0.8 to 1.2
|
49.3 fold rise
Interval 11.2 to 217.8
|
0.8 fold rise
Interval 0.5 to 1.3
|
7.9 fold rise
Interval 3.1 to 20.4
|
0.9 fold rise
Interval 0.8 to 1.0
|
12.7 fold rise
Interval 2.7 to 59.3
|
1.1 fold rise
Interval 0.9 to 1.2
|
|
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
GI.1: II Run:28 Days PD2
|
17 fold rise
Interval 4.9 to 59.2
|
14.1 fold rise
Interval 7.9 to 25.3
|
18.8 fold rise
Interval 9.3 to 37.9
|
23.9 fold rise
Interval 14.4 to 39.7
|
1.4 fold rise
Interval 0.8 to 2.5
|
32 fold rise
Interval 14.5 to 70.5
|
0.8 fold rise
Interval 0.6 to 1.3
|
10.9 fold rise
Interval 3.8 to 31.0
|
1 fold rise
Interval 0.8 to 1.2
|
26.6 fold rise
Interval 11.2 to 63.0
|
1.1 fold rise
Interval 0.9 to 1.3
|
|
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
GI.1: II Run:365 Days PD2
|
9.3 fold rise
Interval 1.7 to 49.5
|
7.9 fold rise
Interval 4.1 to 14.9
|
6.1 fold rise
Interval 3.6 to 10.4
|
11.7 fold rise
Interval 5.0 to 27.4
|
1.1 fold rise
Interval 0.6 to 2.1
|
8.9 fold rise
Interval 4.1 to 19.3
|
0.9 fold rise
Interval 0.5 to 1.6
|
6 fold rise
Interval 2.4 to 15.0
|
1.3 fold rise
Interval 0.7 to 2.5
|
8.2 fold rise
Interval 3.6 to 18.6
|
1 fold rise
Interval 0.9 to 1.2
|
|
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
GII.4: I Run:7 Days PD1
|
2.6 fold rise
Interval 0.8 to 8.3
|
7.1 fold rise
Interval 2.4 to 20.3
|
8.3 fold rise
Interval 3.4 to 20.1
|
2.4 fold rise
Interval 1.1 to 5.1
|
1 fold rise
Interval 0.9 to 1.1
|
6.8 fold rise
Interval 2.2 to 21.1
|
1 fold rise
Interval 1.0 to 1.1
|
2.3 fold rise
Interval 1.2 to 4.4
|
1.4 fold rise
Interval 0.9 to 2.0
|
16.1 fold rise
Interval 5.7 to 45.4
|
1.3 fold rise
Interval 1.0 to 1.6
|
|
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
GI.1: I Run:7 Days PD1
|
16.2 fold rise
Interval 3.8 to 68.7
|
29.4 fold rise
Interval 11.2 to 77.2
|
59.5 fold rise
Interval 27.2 to 130.2
|
54.9 fold rise
Interval 17.6 to 171.0
|
0.7 fold rise
Interval 0.2 to 2.0
|
43 fold rise
Interval 5.9 to 315.7
|
0.9 fold rise
Interval 0.6 to 1.4
|
6.8 fold rise
Interval 2.3 to 20.8
|
0.9 fold rise
Interval 0.8 to 1.0
|
11.2 fold rise
Interval 2.4 to 52.4
|
1 fold rise
Interval 0.9 to 1.1
|
|
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
GI.1: I Run:21 Days PD1
|
20.5 fold rise
Interval 5.2 to 80.2
|
22.8 fold rise
Interval 8.7 to 59.8
|
42 fold rise
Interval 22.6 to 78.3
|
55.2 fold rise
Interval 25.7 to 118.7
|
1 fold rise
Interval 0.8 to 1.2
|
52.5 fold rise
Interval 10.2 to 270.8
|
0.8 fold rise
Interval 0.5 to 1.2
|
7.5 fold rise
Interval 2.4 to 23.1
|
0.9 fold rise
Interval 0.8 to 1.1
|
14.4 fold rise
Interval 2.9 to 71.8
|
1 fold rise
Interval 0.9 to 1.1
|
|
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
GI.1: I Run:7 Days PD2
|
21.6 fold rise
Interval 5.4 to 86.1
|
23.8 fold rise
Interval 9.0 to 63.2
|
26.1 fold rise
Interval 15.2 to 44.8
|
42.8 fold rise
Interval 17.4 to 104.8
|
1.2 fold rise
Interval 0.7 to 2.1
|
59 fold rise
Interval 14.4 to 241.0
|
1 fold rise
Interval 0.6 to 1.7
|
11.3 fold rise
Interval 4.3 to 29.8
|
0.9 fold rise
Interval 0.8 to 1.0
|
14.7 fold rise
Interval 3.1 to 70.3
|
1 fold rise
Interval 0.8 to 1.2
|
|
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
GI.1: I Run:28 Days PD2
|
22 fold rise
Interval 5.6 to 86.3
|
23.1 fold rise
Interval 8.8 to 60.6
|
19.7 fold rise
Interval 11.8 to 32.9
|
32.9 fold rise
Interval 14.6 to 74.5
|
1.2 fold rise
Interval 0.8 to 1.9
|
59.5 fold rise
Interval 16.9 to 209.6
|
0.9 fold rise
Interval 0.5 to 1.5
|
12.6 fold rise
Interval 4.9 to 32.8
|
0.9 fold rise
Interval 0.9 to 1.0
|
17.2 fold rise
Interval 3.6 to 82.7
|
1.1 fold rise
Interval 0.9 to 1.2
|
|
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
GI.1: II Run:152 Days PD2
|
7.9 fold rise
Interval 2.3 to 26.6
|
9.8 fold rise
Interval 5.2 to 18.5
|
9.6 fold rise
Interval 5.1 to 18.0
|
15.5 fold rise
Interval 7.1 to 33.9
|
1.1 fold rise
Interval 0.7 to 1.9
|
15.9 fold rise
Interval 6.5 to 38.9
|
1 fold rise
Interval 0.7 to 1.4
|
8.7 fold rise
Interval 3.3 to 22.7
|
1 fold rise
Interval 0.7 to 1.3
|
11.5 fold rise
Interval 5.1 to 26.0
|
0.9 fold rise
Interval 0.6 to 1.3
|
|
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
GII.4: I Run:21 Days PD1
|
3.8 fold rise
Interval 1.1 to 12.8
|
6.6 fold rise
Interval 2.5 to 17.6
|
6.8 fold rise
Interval 2.8 to 16.1
|
2.3 fold rise
Interval 1.2 to 4.2
|
0.9 fold rise
Interval 0.8 to 1.0
|
11.7 fold rise
Interval 4.7 to 29.2
|
1 fold rise
Interval 0.9 to 1.1
|
3.3 fold rise
Interval 1.4 to 8.0
|
1.3 fold rise
Interval 0.9 to 1.8
|
16.4 fold rise
Interval 7.0 to 38.3
|
1.4 fold rise
Interval 1.0 to 1.8
|
|
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
GII.4: I Run:28 Days PD1
|
3.7 fold rise
Interval 1.1 to 12.8
|
5.1 fold rise
Interval 1.9 to 13.4
|
6 fold rise
Interval 2.6 to 14.3
|
2.2 fold rise
Interval 1.1 to 4.4
|
1.1 fold rise
Interval 0.6 to 2.2
|
10.8 fold rise
Interval 4.2 to 27.9
|
0.9 fold rise
Interval 0.9 to 1.0
|
3 fold rise
Interval 1.4 to 6.4
|
1 fold rise
Interval 0.9 to 1.2
|
13.4 fold rise
Interval 5.7 to 31.6
|
1.3 fold rise
Interval 1.0 to 1.6
|
|
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
GII.4: I Run:7 Days PD2
|
3.8 fold rise
Interval 1.1 to 13.9
|
4.8 fold rise
Interval 1.8 to 12.6
|
6.6 fold rise
Interval 2.7 to 16.1
|
2.5 fold rise
Interval 1.1 to 5.5
|
1.4 fold rise
Interval 0.5 to 4.1
|
12.3 fold rise
Interval 4.6 to 32.6
|
1 fold rise
Interval 0.9 to 1.1
|
3.4 fold rise
Interval 1.4 to 7.9
|
1.2 fold rise
Interval 1.0 to 1.6
|
13.1 fold rise
Interval 6.1 to 27.8
|
1.2 fold rise
Interval 0.9 to 1.5
|
|
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
GII.4: I Run:28 Days PD2
|
4.6 fold rise
Interval 1.3 to 16.3
|
4.6 fold rise
Interval 1.8 to 11.6
|
5.8 fold rise
Interval 2.5 to 13.8
|
2.4 fold rise
Interval 1.2 to 5.0
|
1.5 fold rise
Interval 0.5 to 4.5
|
12.8 fold rise
Interval 4.6 to 35.5
|
1.1 fold rise
Interval 0.9 to 1.3
|
3.7 fold rise
Interval 1.6 to 8.5
|
1.1 fold rise
Interval 0.9 to 1.4
|
12.7 fold rise
Interval 6.3 to 25.5
|
1.3 fold rise
Interval 1.0 to 1.8
|
|
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
GII.4: II Run:28 Days PD2
|
5 fold rise
Interval 2.3 to 10.8
|
6.8 fold rise
Interval 2.8 to 16.4
|
12 fold rise
Interval 5.5 to 26.2
|
3.5 fold rise
Interval 1.1 to 11.5
|
1.6 fold rise
Interval 0.5 to 4.5
|
18.1 fold rise
Interval 4.4 to 74.6
|
1.3 fold rise
Interval 1.0 to 1.6
|
5.7 fold rise
Interval 1.7 to 19.6
|
1 fold rise
Interval 0.7 to 1.5
|
12.2 fold rise
Interval 5.7 to 26.3
|
1 fold rise
Interval 0.9 to 1.2
|
|
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
GII.4: II Run:152 Days PD2
|
3.1 fold rise
Interval 1.4 to 6.7
|
4 fold rise
Interval 1.6 to 10.0
|
3.9 fold rise
Interval 1.5 to 10.0
|
1.7 fold rise
Interval 0.7 to 4.2
|
1.4 fold rise
Interval 0.8 to 2.6
|
13.4 fold rise
Interval 3.4 to 51.9
|
1.2 fold rise
Interval 0.8 to 1.8
|
3.6 fold rise
Interval 0.9 to 14.9
|
1.2 fold rise
Interval 0.6 to 2.3
|
6.5 fold rise
Interval 3.4 to 12.2
|
0.9 fold rise
Interval 0.6 to 1.2
|
|
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
GII.4: II Run:365 Days PD2
|
2.7 fold rise
Interval 1.0 to 7.4
|
4.6 fold rise
Interval 2.0 to 10.6
|
2.4 fold rise
Interval 0.8 to 7.5
|
1.9 fold rise
Interval 0.6 to 5.9
|
1.3 fold rise
Interval 0.7 to 2.5
|
7.7 fold rise
Interval 2.5 to 23.7
|
1.4 fold rise
Interval 0.8 to 2.5
|
2.5 fold rise
Interval 0.6 to 9.9
|
1.9 fold rise
Interval 0.9 to 4.3
|
6 fold rise
Interval 3.2 to 11.2
|
0.9 fold rise
Interval 0.7 to 1.1
|
SECONDARY outcome
Timeframe: I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)Population: Data was not collected because serum specimens were not tested for specific IgM antibodies to Norovirus GI.1 and GII.4 VLPs as per the change in planned analysis, because this measurement was not informative in a previous study LV01-103 (NCT00973284).
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)Population: PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=8 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=7 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
GI.1: I Run:7 Days PD1
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
90.0 percentage of participants
Interval 55.5 to 99.7
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
GII.4: I Run:21 Days PD1
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
50.0 percentage of participants
Interval 18.7 to 81.3
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
GII.4: I Run:28 Days PD1
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
50.0 percentage of participants
Interval 18.7 to 81.3
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
GII.4: I Run:28 Days PD2
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
GII.4: II Run:28 Days PD2
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
GII.4: II Run:152 Days PD2
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
GI.1: I Run:21 Days PD1
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
GII.4: I Run:7 Days PD2
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
50.0 percentage of participants
Interval 18.7 to 81.3
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
GII.4: II Run:365 Days PD2
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
42.6 percentage of participants
Interval 9.9 to 81.6
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
10.0 percentage of participants
Interval 0.3 to 44.5
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
GI.1: I Run:28 Days PD1
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
90.0 percentage of participants
Interval 55.5 to 99.7
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
GI.1: I Run:7 Days PD2
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
GI.1: II Run:365 Days PD2
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
GII.4: I Run:7 Days PD1
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
70.0 percentage of participants
Interval 34.8 to 93.3
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
GI.1: I Run:28 Days PD2
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
GI.1: II Run:28 Days PD2
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
GI.1: II Run:152 Days PD2
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
SECONDARY outcome
Timeframe: I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)Population: PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=8 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=7 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: I Run:7 Days PD2
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
70.0 percentage of participants
Interval 34.8 to 93.3
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: II Run:152 Days PD2
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
25.0 percentage of participants
Interval 3.5 to 65.1
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
10.0 percentage of participants
Interval 0.3 to 44.5
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: I Run:7 Days PD1
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: I Run:21 Days PD1
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: I Run:28 Days PD1
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: I Run:7 Days PD2
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: I Run:28 Days PD2
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: II Run:28 Days PD2
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: II Run:152 Days PD2
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GI.1: II Run:365 Days PD2
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: I Run:7 Days PD1
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
80.0 percentage of participants
Interval 44.4 to 97.5
|
28.6 percentage of participants
Interval 3.7 to 871.0
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: I Run:21 Days PD1
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
70.0 percentage of participants
Interval 34.8 to 93.3
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: I Run:28 Days PD1
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
70.0 percentage of participants
Interval 34.8 to 93.3
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
44.4 percentage of participants
Interval 13.7 to 878.8
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: I Run:28 Days PD2
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: II Run:28 Days PD2
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
GII.4: II Run:365 Days PD2
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
50.0 percentage of participants
Interval 15.7 to 584.3
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
10.0 percentage of participants
Interval 0.3 to 44.5
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
SECONDARY outcome
Timeframe: I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)Population: Data was not collected because serum specimens were not tested for specific IgM antibodies to Norovirus GI.1 and GII.4 VLPs as per the change in planned analysis, because this measurement was not informative in a previous study LV01-103 (NCT00973284).
Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: I run: predose 1, 7, 21, 28 days PD1, 7 and 28 days PD2; II run: predose 1, 28, 152 and 365 days PD2 (up to Day 393)Population: PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
GMTs were assessed for Anti-norovirus GI.1 and GII.4 VLP by Pan-Ig ELISA. A pan ELISA assay captured IgG, IgA and IgM combined. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=7 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GII.4: I Run:28 Days PD1
|
70225 titer
Interval 33407.0 to 147623.0
|
40960 titer
Interval 19180.0 to 87472.0
|
38217 titer
Interval 17951.0 to 81361.0
|
275545 titer
Interval 151249.0 to 501988.0
|
6451 titer
Interval 2151.0 to 19348.0
|
150242 titer
Interval 84602.0 to 266810.0
|
2079 titer
Interval 426.0 to 10158.0
|
111476 titer
Interval 52201.0 to 238058.0
|
7525 titer
Interval 1588.0 to 35664.0
|
126338 titer
Interval 74298.0 to 214829.0
|
7608 titer
Interval 1665.0 to 34773.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GII.4: I Run:7 Days PD1
|
55738 titer
Interval 32476.0 to 95661.0
|
53119 titer
Interval 23492.0 to 120106.0
|
71316 titer
Interval 35649.0 to 142667.0
|
593575 titer
Interval 250592.0 to 1405995.0
|
4740 titer
Interval 1381.0 to 16278.0
|
115852 titer
Interval 45745.0 to 293407.0
|
1940 titer
Interval 377.0 to 9997.0
|
88478 titer
Interval 42773.0 to 183024.0
|
6451 titer
Interval 1429.0 to 29113.0
|
300484 titer
Interval 110464.0 to 817377.0
|
7608 titer
Interval 1665.0 to 34773.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GII.4: I Run:21 Days PD1
|
70225 titer
Interval 39229.0 to 125714.0
|
44667 titer
Interval 20355.0 to 98017.0
|
50428 titer
Interval 24962.0 to 101872.0
|
505352 titer
Interval 297190.0 to 859315.0
|
5120 titer
Interval 1603.0 to 16352.0
|
163840 titer
Interval 81963.0 to 327507.0
|
1810 titer
Interval 329.0 to 9966.0
|
126338 titer
Interval 55875.0 to 285662.0
|
9390 titer
Interval 1854.0 to 47567.0
|
212474 titer
Interval 114914.0 to 392862.0
|
8400 titer
Interval 1694.0 to 41653.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GII.4: I Run:7 Days PD2
|
75848 titer
Interval 40737.0 to 141221.0
|
60866 titer
Interval 36756.0 to 100792.0
|
43900 titer
Interval 24247.0 to 79483.0
|
300484 titer
Interval 185267.0 to 487353.0
|
10240 titer
Interval 3502.0 to 29943.0
|
163840 titer
Interval 88181.0 to 304413.0
|
1810 titer
Interval 329.0 to 9966.0
|
130040 titer
Interval 67714.0 to 249731.0
|
8127 titer
Interval 1573.0 to 41991.0
|
178669 titer
Interval 100609.0 to 317292.0
|
10240 titer
Interval 2130.0 to 49233.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GII.4: I Run:28 Days PD2
|
75848 titer
Interval 34973.0 to 164493.0
|
60866 titer
Interval 36756.0 to 100792.0
|
47781 titer
Interval 25186.0 to 90647.0
|
212474 titer
Interval 106756.0 to 422883.0
|
11167 titer
Interval 3442.0 to 36230.0
|
126338 titer
Interval 68328.0 to 233597.0
|
1810 titer
Interval 363.0 to 9026.0
|
103213 titer
Interval 46414.0 to 229521.0
|
6967 titer
Interval 1405.0 to 34539.0
|
115852 titer
Interval 57957.0 to 231582.0
|
10240 titer
Interval 2330.0 to 45004.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GII.4: II Run:Pre-Dose 1
|
13934 titer
Interval 3481.0 to 55783.0
|
10240 titer
Interval 2841.0 to 36907.0
|
4389 titer
Interval 1026.0 to 18781.0
|
18780 titer
Interval 3498.0 to 100825.0
|
4200 titer
Interval 968.0 to 18216.0
|
3948 titer
Interval 544.0 to 28648.0
|
2560 titer
Interval 606.0 to 10815.0
|
7525 titer
Interval 1257.0 to 45038.0
|
6967 titer
Interval 1540.0 to 31526.0
|
5120 titer
Interval 2022.0 to 12967.0
|
5653 titer
Interval 1106.0 to 28892.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GII.4: II Run:28 Days PD2
|
88478 titer
Interval 44992.0 to 173997.0
|
90447 titer
Interval 38184.0 to 214241.0
|
103213 titer
Interval 65064.0 to 163729.0
|
126338 titer
Interval 63477.0 to 251448.0
|
8400 titer
Interval 1240.0 to 56896.0
|
150242 titer
Interval 78238.0 to 288514.0
|
2560 titer
Interval 727.0 to 9014.0
|
65020 titer
Interval 32132.0 to 131568.0
|
6967 titer
Interval 1577.0 to 30788.0
|
115852 titer
Interval 62354.0 to 215253.0
|
6241 titer
Interval 1439.0 to 27068.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GII.4: II Run:152 Days PD2
|
81920 titer
Interval 34112.0 to 196732.0
|
49931 titer
Interval 24467.0 to 101894.0
|
27869 titer
Interval 15260.0 to 50896.0
|
63169 titer
Interval 34164.0 to 116798.0
|
6241 titer
Interval 1158.0 to 33639.0
|
150242 titer
Interval 48269.0 to 467639.0
|
2744 titer
Interval 740.0 to 10177.0
|
35113 titer
Interval 14643.0 to 84196.0
|
8778 titer
Interval 2002.0 to 38482.0
|
48710 titer
Interval 23176.0 to 102374.0
|
5653 titer
Interval 1321.0 to 24190.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GI.1: I Run: Pre-Dose 1
|
3763 titer
Interval 894.0 to 15838.0
|
2348 titer
Interval 599.0 to 9198.0
|
2560 titer
Interval 950.0 to 6901.0
|
2153 titer
Interval 447.0 to 10366.0
|
1396 titer
Interval 162.0 to 12052.0
|
1810 titer
Interval 486.0 to 6737.0
|
2744 titer
Interval 806.0 to 9337.0
|
6451 titer
Interval 2020.0 to 20603.0
|
2763 titer
Interval 668.0 to 21197.0
|
1280 titer
Interval 320.0 to 5115.0
|
861 titer
Interval 147.0 to 5054.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GII.4: II Run:365 Days PD2
|
45976 titer
Interval 13134.0 to 160938.0
|
49931 titer
Interval 19137.0 to 130278.0
|
20480 titer
Interval 11977.0 to 35021.0
|
67202 titer
Interval 25756.0 to 175341.0
|
3948 titer
Interval 957.0 to 16290.0
|
57926 titer
Interval 33875.0 to 99054.0
|
3378 titer
Interval 690.0 to 16544.0
|
27869 titer
Interval 11467.0 to 67729.0
|
12902 titer
Interval 3151.0 to 52826.0
|
37098 titer
Interval 17025.0 to 80838.0
|
5653 titer
Interval 1321.0 to 24190.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GI.1: I Run:7 Days PD1
|
163840 titer
Interval 77123.0 to 348063.0
|
231705 titer
Interval 135499.0 to 396217.0
|
351199 titer
Interval 159240.0 to 774559.0
|
220512 titer
Interval 57489.0 to 831259.0
|
1185 titer
Interval 179.0 to 7861.0
|
150242 titer
Interval 52704.0 to 428288.0
|
2229 titer
Interval 596.0 to 8327.0
|
151695 titer
Interval 57115.0 to 402894.0
|
3763 titer
Interval 668.0 to 21197.0
|
126338 titer
Interval 39749.0 to 401554.0
|
861 titer
Interval 153.0 to 4860.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GI.1: I Run:21 Days PD1
|
260080 titer
Interval 122425.0 to 552516.0
|
194840 titer
Interval 92705.0 to 409496.0
|
285262 titer
Interval 127800.0 to 636731.0
|
212474 titer
Interval 93970.0 to 480425.0
|
1185 titer
Interval 193.0 to 7282.0
|
212474 titer
Interval 114914.0 to 392862.0
|
2389 titer
Interval 658.0 to 8676.0
|
115852 titer
Interval 51050.0 to 262916.0
|
7241 titer
Interval 2719.0 to 19283.0
|
137772 titer
Interval 58166.0 to 326329.0
|
861 titer
Interval 207.0 to 3587.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GI.1: I Run:28 Days PD1
|
222952 titer
Interval 109569.0 to 453664.0
|
126338 titer
Interval 59394.0 to 268734.0
|
216188 titer
Interval 102476.0 to 456081.0
|
194840 titer
Interval 106949.0 to 354959.0
|
1280 titer
Interval 219.0 to 7493.0
|
212474 titer
Interval 106756.0 to 422883.0
|
2389 titer
Interval 658.0 to 8676.0
|
120401 titer
Interval 56380.0 to 257117.0
|
3763 titer
Interval 696.0 to 20334.0
|
106230 titer
Interval 42084.0 to 268187.0
|
707 titer
Interval 122.0 to 4078.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GI.1: I Run:7 Days PD2
|
176957 titer
Interval 85545.0 to 366049.0
|
163840 titer
Interval 86301.0 to 311047.0
|
266159 titer
Interval 143088.0 to 495085.0
|
212474 titer
Interval 124953.0 to 361298.0
|
1974 titer
Interval 396.0 to 9852.0
|
231705 titer
Interval 169986.0 to 315832.0
|
2229 titer
Interval 584.0 to 8500.0
|
176957 titer
Interval 116676.0 to 268383.0
|
4389 titer
Interval 872.0 to 22081.0
|
126338 titer
Interval 68328.0 to 233597.0
|
861 titer
Interval 207.0 to 3587.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GI.1: I Run:28 Days PD2
|
206425 titer
Interval 102014.0 to 417702.0
|
148394 titer
Interval 83353.0 to 264185.0
|
176957 titer
Interval 81595.0 to 383771.0
|
150242 titer
Interval 92634.0 to 243676.0
|
1974 titer
Interval 352.0 to 11056.0
|
300484 titer
Interval 156475.0 to 577028.0
|
2079 titer
Interval 532.0 to 8134.0
|
176957 titer
Interval 128475.0 to 243735.0
|
5120 titer
Interval 1388.0 to 18883.0
|
89334 titer
Interval 61622.0 to 129510.0
|
861 titer
Interval 180.0 to 4116.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GI.1: II Run:Pre-Dose 1
|
4389 titer
Interval 978.0 to 19405.0
|
3121 titer
Interval 657.0 to 14817.0
|
3484 titer
Interval 870.0 to 13946.0
|
1974 titer
Interval 408.0 to 9540.0
|
3121 titer
Interval 415.0 to 23466.0
|
2560 titer
Interval 803.0 to 8158.0
|
2941 titer
Interval 804.0 to 10760.0
|
4389 titer
Interval 156.0 to 12222.0
|
2560 titer
Interval 567.0 to 11554.0
|
587 titer
Interval 155.0 to 2219.0
|
390 titer
Interval 82.0 to 1852.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GI.1: II Run:28 Days PD2
|
260080 titer
Interval 112007.0 to 603906.0
|
243465 titer
Interval 117694.0 to 503640.0
|
222952 titer
Interval 91740.0 to 541832.0
|
212474 titer
Interval 124953.0 to 361298.0
|
3446 titer
Interval 506.0 to 23456.0
|
357338 titer
Interval 246486.0 to 518042.0
|
2744 titer
Interval 696.0 to 10819.0
|
140451 titer
Interval 98461.0 to 200348.0
|
2195 titer
Interval 392.0 to 12279.0
|
89334 titer
Interval 61622.0 to 129510.0
|
353 titer
Interval 53.0 to 2369.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GI.1: II Run:152 Days PD2
|
97420 titer
Interval 41130.0 to 230749.0
|
121733 titer
Interval 53847.0 to 275205.0
|
95562 titer
Interval 43402.0 to 210408.0
|
126338 titer
Interval 93602.0 to 170523.0
|
3121 titer
Interval 478.0 to 20386.0
|
150242 titer
Interval 103635.0 to 217810.0
|
2941 titer
Interval 756.0 to 11445.0
|
81920 titer
Interval 56204.0 to 119401.0
|
2370 titer
Interval 409.0 to 13721.0
|
31584 titer
Interval 20522.0 to 48609.0
|
390 titer
Interval 75.0 to 2018.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GI.1: II Run:365 Days PD2
|
145965 titer
Interval 62364.0 to 341636.0
|
67202 titer
Interval 25756.0 to 175341.0
|
63169 titer
Interval 21663.0 to 184198.0
|
81920 titer
Interval 48537.0 to 138264.0
|
2153 titer
Interval 409.0 to 11331.0
|
75121 titer
Interval 51817.0 to 108905.0
|
2941 titer
Interval 699.0 to 12376.0
|
47781 titer
Interval 30650.0 to 74487.0
|
3484 titer
Interval 560.0 to 21684.0
|
18549 titer
Interval 10419.0 to 33023.0
|
353 titer
Interval 64.0 to 1960.0
|
|
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GII.4: I Run: Pre-Dose 1
|
11945 titer
Interval 3089.0 to 46196.0
|
3948 titer
Interval 1103.0 to 14126.0
|
1470 titer
Interval 287.0 to 7526.0
|
28963 titer
Interval 5792.0 to 144824.0
|
5583 titer
Interval 1425.0 to 21877.0
|
4695 titer
Interval 804.0 to 27403.0
|
2229 titer
Interval 408.0 to 12181.0
|
9481 titer
Interval 1706.0 to 52683.0
|
8127 titer
Interval 1540.0 to 42902.0
|
6089 titer
Interval 2015.0 to 18402.0
|
9275 titer
Interval 2069.0 to 41572.0
|
SECONDARY outcome
Timeframe: I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)Population: PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
GMFRs in GMTs of Anti-norovirus GI.1 and GII.4 VLP by Pan-Ig ELISA. A pan ELISA assay captured IgG, IgA and IgM combined. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=8 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=7 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GII.4: II Run:152 Days PD2
|
3.7 fold rise
Interval 1.5 to 9.0
|
4.9 fold rise
Interval 1.4 to 17.3
|
6.3 fold rise
Interval 1.9 to 21.5
|
3.4 fold rise
Interval 0.8 to 13.3
|
1.5 fold rise
Interval 0.5 to 4.2
|
38.1 fold rise
Interval 7.0 to 206.1
|
1.1 fold rise
Interval 0.7 to 1.7
|
4.7 fold rise
Interval 0.9 to 23.0
|
1.3 fold rise
Interval 0.5 to 3.4
|
9.5 fold rise
Interval 3.8 to 23.8
|
1 fold rise
Interval 0.7 to 1.4
|
|
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GII.4: II Run:28 Days PD2
|
6.3 fold rise
Interval 1.6 to 24.7
|
8.8 fold rise
Interval 2.5 to 30.9
|
23.5 fold rise
Interval 6.5 to 84.6
|
6.7 fold rise
Interval 1.5 to 29.5
|
2 fold rise
Interval 0.5 to 8.4
|
38.1 fold rise
Interval 6.0 to 242.5
|
1 fold rise
Interval 0.8 to 1.3
|
8.6 fold rise
Interval 1.9 to 40.3
|
1 fold rise
Interval 0.8 to 1.3
|
22.6 fold rise
Interval 8.5 to 60.3
|
1.1 fold rise
Interval 0.9 to 1.4
|
|
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GII.4: I Run:7 Days PD2
|
6.3 fold rise
Interval 2.0 to 20.3
|
10.8 fold rise
Interval 2.9 to 40.6
|
29.9 fold rise
Interval 6.1 to 146.9
|
10.4 fold rise
Interval 2.1 to 50.2
|
1.8 fold rise
Interval 0.5 to 6.2
|
34.9 fold rise
Interval 6.3 to 192.7
|
0.8 fold rise
Interval 0.6 to 1.1
|
13.7 fold rise
Interval 3.1 to 60.1
|
1 fold rise
Interval 0.8 to 1.3
|
29.3 fold rise
Interval 8.4 to 103.0
|
1.1 fold rise
Interval 0.7 to 1.7
|
|
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GI.1: I Run:7 Days PD1
|
43.5 fold rise
Interval 9.9 to 192.4
|
98.7 fold rise
Interval 21.7 to 449.2
|
137.2 fold rise
Interval 50.3 to 374.4
|
128 fold rise
Interval 61.1 to 268.3
|
1 fold rise
Confidence interval could not be calculated because there was no variance in the observed data.
|
83 fold rise
Interval 9.7 to 708.7
|
0.8 fold rise
Interval 0.6 to 1.0
|
23.5 fold rise
Interval 5.5 to 101.4
|
1 fold rise
Confidence interval could not be calculated because there was no variance in the observed data.
|
98.7 fold rise
Interval 28.7 to 339.9
|
1 fold rise
Interval 0.7 to 1.4
|
|
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GI.1: I Run:21 Days PD1
|
69.1 fold rise
Interval 15.9 to 300.6
|
83 fold rise
Interval 17.7 to 389.8
|
111.4 fold rise
Interval 51.7 to 240.2
|
98.7 fold rise
Interval 41.2 to 236.2
|
1.1 fold rise
Interval 0.8 to 1.6
|
117.4 fold rise
Interval 23.2 to 594.6
|
0.9 fold rise
Interval 0.7 to 1.1
|
20.7 fold rise
Interval 4.2 to 103.6
|
1 fold rise
Confidence interval could not be calculated because there was no variance in the observed data.
|
107.6 fold rise
Interval 23.8 to 487.0
|
1 fold rise
Interval 0.6 to 1.7
|
|
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GI.1: I Run:28 Days PD1
|
59.3 fold rise
Interval 12.4 to 283.0
|
53.8 fold rise
Interval 11.5 to 251.3
|
84.4 fold rise
Interval 49.6 to 143.9
|
90.5 fold rise
Interval 31.0 to 264.7
|
1.2 fold rise
Interval 0.8 to 1.8
|
117.4 fold rise
Interval 19.1 to 722.8
|
0.9 fold rise
Interval 0.7 to 1.1
|
18.7 fold rise
Interval 5.7 to 61.0
|
1 fold rise
Interval 0.8 to 1.3
|
83 fold rise
Interval 18.2 to 377.8
|
0.8 fold rise
Interval 0.6 to 1.1
|
|
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GI.1: I Run:7 Days PD2
|
47 fold rise
Interval 8.9 to 248.9
|
78 fold rise
Interval 15.1 to 403.5
|
104 fold rise
Interval 58.5 to 184.8
|
98.7 fold rise
Interval 31.1 to 313.7
|
1.4 fold rise
Interval 0.6 to 3.2
|
128 fold rise
Interval 29.0 to 565.4
|
0.8 fold rise
Interval 0.6 to 1.0
|
27.4 fold rise
Interval 8.9 to 84.3
|
1.2 fold rise
Interval 0.9 to 1.5
|
98.7 fold rise
Interval 28.7 to 339.9
|
1 fold rise
Interval 0.6 to 1.7
|
|
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GI.1: I Run:28 Days PD2
|
54.9 fold rise
Interval 10.2 to 294.4
|
70.7 fold rise
Interval 16.5 to 302.4
|
64 fold rise
Interval 37.6 to 109.0
|
69.8 fold rise
Interval 20.7 to 235.7
|
1.4 fold rise
Interval 0.6 to 3.2
|
166 fold rise
Interval 35.3 to 779.6
|
0.8 fold rise
Interval 0.5 to 1.1
|
27.4 fold rise
Interval 9.9 to 76.4
|
1.4 fold rise
Interval 0.7 to 2.5
|
69.8 fold rise
Interval 19.9 to 245.0
|
1 fold rise
Interval 0.7 to 1.4
|
|
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GI.1: II Run:28 Days PD2
|
59.3 fold rise
Interval 13.0 to 270.2
|
78 fold rise
Interval 16.4 to 370.4
|
64 fold rise
Interval 31.6 to 129.5
|
107.6 fold rise
Interval 34.1 to 339.4
|
1.1 fold rise
Interval 0.6 to 2.0
|
139.6 fold rise
Interval 46.8 to 416.2
|
0.9 fold rise
Interval 0.6 to 1.3
|
32 fold rise
Interval 12.2 to 83.6
|
0.9 fold rise
Interval 0.7 to 1.1
|
152.2 fold rise
Interval 41.3 to 561.3
|
0.9 fold rise
Interval 0.6 to 1.4
|
|
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GI.1: II Run:152 Days PD2
|
17.4 fold rise
Interval 4.3 to 70.8
|
39 fold rise
Interval 7.9 to 193.4
|
27.4 fold rise
Interval 11.9 to 63.1
|
64 fold rise
Interval 15.0 to 273.6
|
1 fold rise
Interval 0.7 to 1.4
|
58.7 fold rise
Interval 21.6 to 159.6
|
1 fold rise
Interval 0.7 to 1.5
|
18.7 fold rise
Interval 8.5 to 41.1
|
0.9 fold rise
Interval 0.7 to 1.3
|
53.8 fold rise
Interval 15.7 to 184.0
|
1 fold rise
Interval 0.7 to 1.4
|
|
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GI.1: II Run:365 Days PD2
|
25.4 fold rise
Interval 2.1 to 311.2
|
21.5 fold rise
Interval 4.7 to 98.4
|
19 fold rise
Interval 8.5 to 42.5
|
58 fold rise
Interval 16.6 to 202.6
|
1 fold rise
Interval 0.6 to 1.7
|
29.3 fold rise
Interval 10.8 to 79.8
|
1 fold rise
Interval 0.7 to 1.5
|
10.9 fold rise
Interval 3.7 to 31.7
|
1.4 fold rise
Interval 0.7 to 2.5
|
43.1 fold rise
Interval 19.7 to 97.4
|
0.9 fold rise
Interval 0.6 to 1.4
|
|
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GII.4: I Run:7 Days PD1
|
4.7 fold rise
Interval 1.5 to 14.3
|
13.5 fold rise
Interval 3.0 to 60.9
|
48.5 fold rise
Interval 7.9 to 297.4
|
19.5 fold rise
Interval 1.8 to 213.0
|
1 fold rise
Confidence interval could not be calculated because there was no variance in the observed data.
|
24.7 fold rise
Interval 4.7 to 130.6
|
0.9 fold rise
Interval 0.6 to 1.2
|
9.3 fold rise
Interval 2.2 to 39.9
|
0.8 fold rise
Interval 0.6 to 1.0
|
49.4 fold rise
Interval 9.6 to 253.7
|
0.8 fold rise
Interval 0.6 to 1.1
|
|
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GII.4: I Run:21 Days PD1
|
5.9 fold rise
Interval 1.5 to 23.5
|
11.3 fold rise
Interval 3.6 to 36.1
|
34.3 fold rise
Interval 7.3 to 160.1
|
17.4 fold rise
Interval 3.2 to 96.4
|
1.1 fold rise
Interval 0.8 to 1.6
|
34.9 fold rise
Interval 7.1 to 171.6
|
0.8 fold rise
Interval 0.6 to 1.1
|
19 fold rise
Interval 5.4 to 67.6
|
0.8 fold rise
Interval 0.6 to 1.1
|
34.9 fold rise
Interval 7.5 to 131.4
|
0.9 fold rise
Interval 0.6 to 1.4
|
|
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GII.4: I Run:28 Days PD1
|
5.9 fold rise
Interval 1.5 to 22.3
|
10.4 fold rise
Interval 3.6 to 30.3
|
26 fold rise
Interval 5.1 to 131.4
|
9.5 fold rise
Interval 1.8 to 50.1
|
1.4 fold rise
Interval 0.8 to 2.6
|
32 fold rise
Interval 7.7 to 132.3
|
0.9 fold rise
Interval 0.7 to 1.2
|
11.8 fold rise
Interval 3.0 to 45.9
|
0.9 fold rise
Interval 0.8 to 1.1
|
20.7 fold rise
Interval 5.2 to 82.7
|
0.8 fold rise
Interval 0.6 to 1.1
|
|
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GII.4: I Run:28 Days PD2
|
6.3 fold rise
Interval 1.7 to 24.1
|
10.8 fold rise
Interval 3.4 to 34.4
|
21.8 fold rise
Interval 6.6 to 71.9
|
7.3 fold rise
Interval 1.5 to 35.0
|
2 fold rise
Interval 0.5 to 8.3
|
26.9 fold rise
Interval 5.4 to 133.6
|
0.8 fold rise
Interval 0.6 to 1.1
|
10.9 fold rise
Interval 2.5 to 48.1
|
0.9 fold rise
Interval 0.7 to 1.1
|
19 fold rise
Interval 5.4 to 67.6
|
1.1 fold rise
Interval 0.7 to 1.7
|
|
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GII.4: II Run:365 Days PD2
|
4 fold rise
Interval 0.7 to 23.8
|
4.9 fold rise
Interval 1.2 to 19.2
|
3.4 fold rise
Interval 0.8 to 13.3
|
3.3 fold rise
Interval 0.6 to 17.0
|
1.2 fold rise
Interval 0.5 to 2.7
|
14.7 fold rise
Interval 2.2 to 100.1
|
1.3 fold rise
Interval 0.6 to 2.8
|
3.7 fold rise
Interval 0.9 to 16.1
|
1.9 fold rise
Interval 0.8 to 4.4
|
8.8 fold rise
Interval 4.1 to 19.2
|
1 fold rise
Interval 0.7 to 1.4
|
SECONDARY outcome
Timeframe: I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)Population: PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Outcome measures
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=8 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 Participants
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=7 Participants
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
GI.1: I Run:7 Days PD1
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
GI.1: II Run:152 Days PD2
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
GI.1: II Run:365 Days PD2
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
GII.4: I Run:7 Days PD1
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
80.0 percentage of participants
Interval 44.4 to 97.5
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
GII.4: I Run:21 Days PD1
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
80.0 percentage of participants
Interval 44.4 to 97.5
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
GII.4: I Run:7 Days PD2
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
80.0 percentage of participants
Interval 44.4 to 97.5
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
GII.4: I Run:28 Days PD2
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
85.7 percentage of participants
Interval 42.1 to 96.6
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
GII.4: II Run:28 Days PD2
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
GII.4: I Run:28 Days PD1
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
80.0 percentage of participants
Interval 44.4 to 97.5
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
GI.1: I Run:21 Days PD1
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
GI.1: I Run:28 Days PD1
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
GI.1: I Run:7 Days PD2
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
GI.1: I Run:28 Days PD2
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
GI.1: II Run:28 Days PD2
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
GII.4: II Run:152 Days PD2
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
10.0 percentage of participants
Interval 0.3 to 44.5
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
GII.4: II Run:365 Days PD2
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
14.3 percentage of participants
Interval 0.4 to 57.6
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
10.0 percentage of participants
Interval 0.3 to 44.5
|
55.6 percentage of participants
Interval 21.2 to 86.3
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
Adverse Events
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort A1-A4: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort B: Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort C: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort D: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=10 participants at risk
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=10 participants at risk
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 participants at risk
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=9 participants at risk
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=9 participants at risk
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 participants at risk
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 participants at risk
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 participants at risk
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 participants at risk
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 participants at risk
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=8 participants at risk
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Idiopathic central retinal vein occlusion
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Chest pain
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastroparesis
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fractured right fibula
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Bleeding following urologic surgery
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg
n=10 participants at risk
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg
n=10 participants at risk
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 participants at risk
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg
n=9 participants at risk
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort A1-A4: Placebo
n=9 participants at risk
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=9 participants at risk
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort B: Placebo
n=10 participants at risk
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
|
Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg
n=10 participants at risk
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort C: Placebo
n=9 participants at risk
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
|
Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg
n=8 participants at risk
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
Cohort D: Placebo
n=8 participants at risk
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chills
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site haematoma
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site pruritus
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Croup infectious
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
30.0%
3/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
22.2%
2/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
22.2%
2/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood glucose increased
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cell count increased
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Capillary fragility
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Nodule
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nail bed infection
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Otitis media
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Mean cell haemoglobin decreased
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Red cell distribution width increased
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 365 Days after post dose 2 (Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER