Trial Outcomes & Findings for Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine (NCT NCT02038907)
NCT ID: NCT02038907
Last Updated: 2017-08-08
Results Overview
Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
420 participants
Primary outcome timeframe
Baseline and Day 56
Results posted on
2017-08-08
Participant Flow
Participants took part in the study at 2 investigative sites in Belgium from 28 March 2014 (first participants signed the informed consent form) to 19 June 2015.
Healthy volunteers were enrolled equally in 1 of 14 unique formulation treatment groups: 11 formulation arms received 1 dose and 3 formulation arms received 2 doses.
Participant milestones
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
31
|
30
|
31
|
30
|
32
|
29
|
30
|
29
|
28
|
29
|
31
|
|
Overall Study
COMPLETED
|
30
|
30
|
30
|
31
|
30
|
31
|
30
|
32
|
29
|
30
|
27
|
28
|
29
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine
Baseline characteristics by cohort
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.0 years
FULL_RANGE 14.70 • n=5 Participants
|
51.0 years
FULL_RANGE 14.36 • n=7 Participants
|
50.0 years
FULL_RANGE 12.95 • n=5 Participants
|
50.0 years
FULL_RANGE 14.95 • n=4 Participants
|
49.5 years
FULL_RANGE 13.79 • n=21 Participants
|
50.0 years
FULL_RANGE 14.39 • n=10 Participants
|
49.5 years
FULL_RANGE 14.19 • n=115 Participants
|
48.5 years
FULL_RANGE 14.13 • n=24 Participants
|
41.0 years
FULL_RANGE 14.82 • n=42 Participants
|
51.0 years
FULL_RANGE 15.26 • n=42 Participants
|
49.0 years
FULL_RANGE 15.41 • n=42 Participants
|
48.5 years
FULL_RANGE 14.05 • n=42 Participants
|
48.0 years
FULL_RANGE 15.06 • n=36 Participants
|
44.0 years
FULL_RANGE 16.11 • n=36 Participants
|
49.5 years
n=24 Participants
|
|
Age, Customized
18-49 Years
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
15 participants
n=5 Participants
|
15 participants
n=4 Participants
|
15 participants
n=21 Participants
|
15 participants
n=10 Participants
|
15 participants
n=115 Participants
|
16 participants
n=24 Participants
|
15 participants
n=42 Participants
|
15 participants
n=42 Participants
|
15 participants
n=42 Participants
|
14 participants
n=42 Participants
|
15 participants
n=36 Participants
|
16 participants
n=36 Participants
|
210 participants
n=24 Participants
|
|
Age, Customized
50-64 Years
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
15 participants
n=5 Participants
|
16 participants
n=4 Participants
|
15 participants
n=21 Participants
|
16 participants
n=10 Participants
|
15 participants
n=115 Participants
|
16 participants
n=24 Participants
|
14 participants
n=42 Participants
|
15 participants
n=42 Participants
|
14 participants
n=42 Participants
|
14 participants
n=42 Participants
|
14 participants
n=36 Participants
|
15 participants
n=36 Participants
|
210 participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
18 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
20 Participants
n=36 Participants
|
18 Participants
n=36 Participants
|
268 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
14 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
13 Participants
n=36 Participants
|
152 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
1 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
1 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
5 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
30 participants
n=5 Participants
|
30 participants
n=4 Participants
|
30 participants
n=21 Participants
|
29 participants
n=10 Participants
|
30 participants
n=115 Participants
|
32 participants
n=24 Participants
|
28 participants
n=42 Participants
|
29 participants
n=42 Participants
|
29 participants
n=42 Participants
|
28 participants
n=42 Participants
|
29 participants
n=36 Participants
|
31 participants
n=36 Participants
|
414 participants
n=24 Participants
|
|
Region of Enrollment
Belgium
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
30 participants
n=5 Participants
|
31 participants
n=4 Participants
|
30 participants
n=21 Participants
|
31 participants
n=10 Participants
|
30 participants
n=115 Participants
|
32 participants
n=24 Participants
|
29 participants
n=42 Participants
|
30 participants
n=42 Participants
|
29 participants
n=42 Participants
|
28 participants
n=42 Participants
|
29 participants
n=36 Participants
|
31 participants
n=36 Participants
|
420 participants
n=24 Participants
|
|
Height
|
173.0 cm
n=5 Participants
|
167.0 cm
n=7 Participants
|
166.5 cm
n=5 Participants
|
167.0 cm
n=4 Participants
|
171.0 cm
n=21 Participants
|
169.0 cm
n=10 Participants
|
173.5 cm
n=115 Participants
|
169.5 cm
n=24 Participants
|
171.0 cm
n=42 Participants
|
167.0 cm
n=42 Participants
|
172.0 cm
n=42 Participants
|
171.5 cm
n=42 Participants
|
170.0 cm
n=36 Participants
|
175.0 cm
n=36 Participants
|
170.0 cm
n=24 Participants
|
|
Weight
|
69.50 kg
n=5 Participants
|
65.60 kg
n=7 Participants
|
70.60 kg
n=5 Participants
|
66.60 kg
n=4 Participants
|
71.60 kg
n=21 Participants
|
68.50 kg
n=10 Participants
|
72.50 kg
n=115 Participants
|
74.35 kg
n=24 Participants
|
76.00 kg
n=42 Participants
|
69.85 kg
n=42 Participants
|
70.00 kg
n=42 Participants
|
75.50 kg
n=42 Participants
|
70.60 kg
n=36 Participants
|
69.90 kg
n=36 Participants
|
70.8 kg
n=24 Participants
|
|
Body Mass Index (BMI)
|
25.22 kg/m^2
n=5 Participants
|
23.97 kg/m^2
n=7 Participants
|
26.11 kg/m^2
n=5 Participants
|
23.62 kg/m^2
n=4 Participants
|
24.51 kg/m^2
n=21 Participants
|
24.73 kg/m^2
n=10 Participants
|
24.40 kg/m^2
n=115 Participants
|
24.06 kg/m^2
n=24 Participants
|
26.06 kg/m^2
n=42 Participants
|
25.02 kg/m^2
n=42 Participants
|
23.66 kg/m^2
n=42 Participants
|
24.24 kg/m^2
n=42 Participants
|
23.19 kg/m^2
n=36 Participants
|
24.54 kg/m^2
n=36 Participants
|
24.52 kg/m^2
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 56Population: Full Analysis Set included all randomized participants who received at least one dose of trial vaccine.
Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=26 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Seroresponse (Pan-Ig ELISA)
|
43.3 percentage of participants
Interval 25.5 to 62.6
|
62.1 percentage of participants
Interval 42.3 to 79.3
|
46.4 percentage of participants
Interval 27.5 to 66.1
|
35.5 percentage of participants
Interval 19.2 to 54.6
|
80.0 percentage of participants
Interval 61.4 to 92.3
|
67.7 percentage of participants
Interval 48.6 to 83.3
|
30.0 percentage of participants
Interval 14.7 to 49.4
|
62.5 percentage of participants
Interval 43.7 to 78.9
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
66.7 percentage of participants
Interval 47.2 to 82.7
|
46.2 percentage of participants
Interval 26.6 to 66.6
|
71.4 percentage of participants
Interval 51.3 to 86.8
|
69.0 percentage of participants
Interval 49.2 to 84.7
|
56.7 percentage of participants
Interval 37.4 to 74.5
|
PRIMARY outcome
Timeframe: Days 1 through 7Population: Safety population included all participants who received at least one dose of trial vaccine.
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1
Pain
|
43.3 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
32.3 percentage of participants
|
46.7 percentage of participants
|
38.7 percentage of participants
|
40.0 percentage of participants
|
53.1 percentage of participants
|
44.8 percentage of participants
|
53.3 percentage of participants
|
48.3 percentage of participants
|
46.4 percentage of participants
|
31.0 percentage of participants
|
32.3 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1
Erythema
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1
Induration
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1
Swelling
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Days 28 through 34Population: Safety population included all participants who received at least one dose of trial vaccine.
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2
Pain
|
60.0 percentage of participants
|
36.7 percentage of participants
|
66.7 percentage of participants
|
51.6 percentage of participants
|
53.3 percentage of participants
|
58.1 percentage of participants
|
33.3 percentage of participants
|
43.8 percentage of participants
|
48.3 percentage of participants
|
46.7 percentage of participants
|
34.5 percentage of participants
|
32.1 percentage of participants
|
41.4 percentage of participants
|
35.5 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2
Erythema
|
0 percentage of participants
|
0 percentage of participants
|
3.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.4 percentage of participants
|
3.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2
Induration
|
0 percentage of participants
|
0 percentage of participants
|
3.3 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.4 percentage of participants
|
3.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2
Swelling
|
0 percentage of participants
|
3.3 percentage of participants
|
0 percentage of participants
|
3.2 percentage of participants
|
0 percentage of participants
|
3.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Days 1 through 7Population: Safety population included all participants who received at least one dose of trial vaccine.
Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1
Headache
|
20.0 percentage of participants
|
26.7 percentage of participants
|
3.3 percentage of participants
|
19.4 percentage of participants
|
16.7 percentage of participants
|
12.9 percentage of participants
|
13.3 percentage of participants
|
25.0 percentage of participants
|
27.6 percentage of participants
|
20.0 percentage of participants
|
13.8 percentage of participants
|
17.9 percentage of participants
|
31.0 percentage of participants
|
19.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1
Fatigue
|
23.3 percentage of participants
|
23.3 percentage of participants
|
16.7 percentage of participants
|
19.4 percentage of participants
|
10.0 percentage of participants
|
12.9 percentage of participants
|
13.3 percentage of participants
|
15.6 percentage of participants
|
17.2 percentage of participants
|
20.0 percentage of participants
|
24.1 percentage of participants
|
25.0 percentage of participants
|
17.2 percentage of participants
|
22.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1
Myalgia
|
20.0 percentage of participants
|
6.7 percentage of participants
|
13.3 percentage of participants
|
6.5 percentage of participants
|
3.3 percentage of participants
|
9.7 percentage of participants
|
6.7 percentage of participants
|
18.8 percentage of participants
|
10.3 percentage of participants
|
10.0 percentage of participants
|
17.2 percentage of participants
|
10.7 percentage of participants
|
3.4 percentage of participants
|
19.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1
Arthralgia
|
0 percentage of participants
|
3.3 percentage of participants
|
6.7 percentage of participants
|
0 percentage of participants
|
3.3 percentage of participants
|
0 percentage of participants
|
3.3 percentage of participants
|
6.3 percentage of participants
|
6.9 percentage of participants
|
3.3 percentage of participants
|
3.4 percentage of participants
|
3.6 percentage of participants
|
3.4 percentage of participants
|
3.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1
Vomiting
|
0 percentage of participants
|
3.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.3 percentage of participants
|
3.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1
Diarrhea
|
0 percentage of participants
|
23.3 percentage of participants
|
3.3 percentage of participants
|
16.1 percentage of participants
|
20.0 percentage of participants
|
6.5 percentage of participants
|
13.3 percentage of participants
|
12.5 percentage of participants
|
13.8 percentage of participants
|
10.0 percentage of participants
|
6.9 percentage of participants
|
7.1 percentage of participants
|
10.3 percentage of participants
|
12.9 percentage of participants
|
PRIMARY outcome
Timeframe: Days 28 through 34Population: Safety population included all participants who received at least one dose of trial vaccine.
Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2
Vomiting
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.3 percentage of participants
|
3.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2
Headache
|
13.3 percentage of participants
|
13.3 percentage of participants
|
13.3 percentage of participants
|
22.6 percentage of participants
|
23.3 percentage of participants
|
16.1 percentage of participants
|
10.0 percentage of participants
|
21.9 percentage of participants
|
20.7 percentage of participants
|
10.0 percentage of participants
|
13.8 percentage of participants
|
14.3 percentage of participants
|
34.5 percentage of participants
|
19.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2
Fatigue
|
16.7 percentage of participants
|
13.3 percentage of participants
|
20.0 percentage of participants
|
12.9 percentage of participants
|
10.0 percentage of participants
|
12.9 percentage of participants
|
10.0 percentage of participants
|
18.8 percentage of participants
|
17.2 percentage of participants
|
13.3 percentage of participants
|
13.8 percentage of participants
|
7.1 percentage of participants
|
13.8 percentage of participants
|
12.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2
Myalgia
|
13.3 percentage of participants
|
3.3 percentage of participants
|
13.3 percentage of participants
|
0 percentage of participants
|
13.3 percentage of participants
|
12.9 percentage of participants
|
0 percentage of participants
|
6.3 percentage of participants
|
6.9 percentage of participants
|
0 percentage of participants
|
10.3 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
6.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2
Arthralgia
|
0 percentage of participants
|
3.3 percentage of participants
|
3.3 percentage of participants
|
0 percentage of participants
|
3.3 percentage of participants
|
3.2 percentage of participants
|
0 percentage of participants
|
3.1 percentage of participants
|
0 percentage of participants
|
3.3 percentage of participants
|
3.4 percentage of participants
|
3.6 percentage of participants
|
0 percentage of participants
|
3.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2
Diarrhea
|
3.3 percentage of participants
|
10.0 percentage of participants
|
16.7 percentage of participants
|
12.9 percentage of participants
|
16.7 percentage of participants
|
9.7 percentage of participants
|
6.7 percentage of participants
|
15.6 percentage of participants
|
17.2 percentage of participants
|
10.0 percentage of participants
|
3.4 percentage of participants
|
7.1 percentage of participants
|
6.9 percentage of participants
|
3.2 percentage of participants
|
PRIMARY outcome
Timeframe: Days 1 through 7Population: Safety population included all participants who received at least one dose of trial vaccine.
Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site.
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Oral Body Temperature Within 7 Days After Dose 1
|
36.54 degrees Celsius
Standard Deviation 0.294
|
36.76 degrees Celsius
Standard Deviation 0.376
|
36.66 degrees Celsius
Standard Deviation 0.345
|
36.71 degrees Celsius
Standard Deviation 0.260
|
36.65 degrees Celsius
Standard Deviation 0.388
|
36.67 degrees Celsius
Standard Deviation 0.255
|
36.74 degrees Celsius
Standard Deviation 0.323
|
36.63 degrees Celsius
Standard Deviation 0.366
|
36.52 degrees Celsius
Standard Deviation 0.405
|
36.77 degrees Celsius
Standard Deviation 0.341
|
36.71 degrees Celsius
Standard Deviation 0.404
|
36.61 degrees Celsius
Standard Deviation 0.368
|
36.70 degrees Celsius
Standard Deviation 0.362
|
36.61 degrees Celsius
Standard Deviation 0.381
|
PRIMARY outcome
Timeframe: Days 28 through 34Population: Safety population included all participants who received at least one dose of trial vaccine.
Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site.
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=27 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Oral Body Temperature Within 7 Days After Dose 2
|
36.54 degrees Celsius
Standard Deviation 0.282
|
36.76 degrees Celsius
Standard Deviation 0.301
|
36.68 degrees Celsius
Standard Deviation 0.351
|
36.75 degrees Celsius
Standard Deviation 0.466
|
36.60 degrees Celsius
Standard Deviation 0.286
|
36.72 degrees Celsius
Standard Deviation 0.317
|
36.71 degrees Celsius
Standard Deviation 0.394
|
36.64 degrees Celsius
Standard Deviation 0.342
|
36.59 degrees Celsius
Standard Deviation 0.463
|
36.73 degrees Celsius
Standard Deviation 0.293
|
36.68 degrees Celsius
Standard Deviation 0.345
|
36.56 degrees Celsius
Standard Deviation 0.351
|
36.76 degrees Celsius
Standard Deviation 0.391
|
36.61 degrees Celsius
Standard Deviation 0.386
|
PRIMARY outcome
Timeframe: Day 1 up to Day 56Population: Safety population included all participants who received at least one dose of trial vaccine.
Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Unsolicited Adverse Events (AEs)
|
56.7 percentage of participants
|
60.0 percentage of participants
|
53.3 percentage of participants
|
45.2 percentage of participants
|
43.3 percentage of participants
|
54.8 percentage of participants
|
43.3 percentage of participants
|
62.5 percentage of participants
|
69.0 percentage of participants
|
43.3 percentage of participants
|
48.3 percentage of participants
|
50.0 percentage of participants
|
51.7 percentage of participants
|
61.3 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 393Population: Safety population included all participants who received at least one dose of trial vaccine.
A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs)
|
6.7 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
6.5 percentage of participants
|
3.3 percentage of participants
|
0 percentage of participants
|
10.0 percentage of participants
|
9.4 percentage of participants
|
3.4 percentage of participants
|
3.3 percentage of participants
|
3.4 percentage of participants
|
7.1 percentage of participants
|
3.4 percentage of participants
|
3.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Days 28, 208 and 393Population: Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)
|
17.2 percentage of participants
Interval 5.8 to 35.8
|
20.7 percentage of participants
Interval 8.0 to 39.7
|
13.3 percentage of participants
Interval 3.8 to 30.7
|
16.1 percentage of participants
Interval 5.5 to 33.7
|
10.0 percentage of participants
Interval 2.1 to 26.5
|
13.8 percentage of participants
Interval 3.9 to 31.7
|
10.3 percentage of participants
Interval 2.2 to 27.4
|
15.6 percentage of participants
Interval 5.3 to 32.8
|
6.9 percentage of participants
Interval 0.8 to 22.8
|
13.3 percentage of participants
Interval 3.8 to 30.7
|
7.4 percentage of participants
Interval 0.9 to 24.3
|
21.4 percentage of participants
Interval 8.3 to 41.0
|
20.7 percentage of participants
Interval 8.0 to 39.7
|
20.7 percentage of participants
Interval 8.0 to 39.7
|
|
Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 12.3
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 12.8
|
71.4 percentage of participants
Interval 51.3 to 86.8
|
79.3 percentage of participants
Interval 60.3 to 92.0
|
67.7 percentage of participants
Interval 48.6 to 83.3
|
|
Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)
|
10.0 percentage of participants
Interval 2.1 to 26.5
|
17.2 percentage of participants
Interval 5.8 to 35.8
|
10.0 percentage of participants
Interval 2.1 to 26.5
|
19.4 percentage of participants
Interval 7.5 to 37.5
|
20.0 percentage of participants
Interval 7.7 to 38.6
|
20.0 percentage of participants
Interval 7.7 to 38.6
|
6.7 percentage of participants
Interval 0.8 to 22.1
|
34.4 percentage of participants
Interval 18.6 to 53.2
|
17.2 percentage of participants
Interval 5.8 to 35.8
|
23.3 percentage of participants
Interval 9.9 to 42.3
|
14.8 percentage of participants
Interval 4.2 to 33.7
|
32.1 percentage of participants
Interval 15.9 to 52.4
|
34.5 percentage of participants
Interval 17.9 to 54.3
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
SECONDARY outcome
Timeframe: Baseline and Days 28, 56, 208 and 393Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=24 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)
|
60.0 percentage of participants
Interval 40.6 to 77.3
|
65.5 percentage of participants
Interval 45.7 to 82.1
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
72.4 percentage of participants
Interval 52.8 to 87.3
|
70.0 percentage of participants
Interval 50.6 to 85.3
|
73.3 percentage of participants
Interval 54.1 to 87.7
|
66.7 percentage of participants
Interval 47.2 to 82.7
|
62.5 percentage of participants
Interval 43.7 to 78.9
|
85.7 percentage of participants
Interval 67.3 to 96.0
|
60.0 percentage of participants
Interval 40.6 to 77.3
|
54.2 percentage of participants
Interval 32.8 to 74.4
|
71.4 percentage of participants
Interval 51.3 to 86.8
|
75.9 percentage of participants
Interval 56.5 to 89.7
|
74.1 percentage of participants
Interval 53.7 to 88.9
|
|
Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.9
|
0 percentage of participants
Interval 0.0 to 12.8
|
6.9 percentage of participants
Interval 0.8 to 22.8
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 12.8
|
0 percentage of participants
Interval 0.0 to 11.6
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
85.7 percentage of participants
Interval 67.3 to 96.0
|
93.1 percentage of participants
Interval 77.2 to 99.2
|
93.3 percentage of participants
Interval 77.9 to 99.2
|
|
Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
80.0 percentage of participants
Interval 61.4 to 92.3
|
89.7 percentage of participants
Interval 72.6 to 97.8
|
100.0 percentage of participants
Interval 87.7 to 100.0
|
89.7 percentage of participants
Interval 72.6 to 97.8
|
93.3 percentage of participants
Interval 77.9 to 99.2
|
96.8 percentage of participants
Interval 83.3 to 99.9
|
86.7 percentage of participants
Interval 69.3 to 96.2
|
87.5 percentage of participants
Interval 71.0 to 96.5
|
92.9 percentage of participants
Interval 76.5 to 99.1
|
90.0 percentage of participants
Interval 73.5 to 97.9
|
83.3 percentage of participants
Interval 62.6 to 95.3
|
85.7 percentage of participants
Interval 67.3 to 96.0
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
86.7 percentage of participants
Interval 69.3 to 96.2
|
|
Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)
|
55.2 percentage of participants
Interval 35.7 to 73.6
|
46.4 percentage of participants
Interval 27.5 to 66.1
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
69.0 percentage of participants
Interval 49.2 to 84.7
|
63.3 percentage of participants
Interval 43.9 to 80.1
|
65.5 percentage of participants
Interval 45.7 to 82.1
|
55.2 percentage of participants
Interval 35.7 to 73.6
|
53.1 percentage of participants
Interval 34.7 to 70.9
|
82.1 percentage of participants
Interval 63.1 to 93.9
|
43.3 percentage of participants
Interval 25.5 to 62.6
|
45.8 percentage of participants
Interval 25.6 to 67.2
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
72.4 percentage of participants
Interval 52.8 to 87.3
|
78.6 percentage of participants
Interval 59.0 to 91.7
|
SECONDARY outcome
Timeframe: Baseline and Days 28, 56, 208 and 393Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
The percentage of participants with a 4-fold rise or greater from in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=24 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)
|
16.7 percentage of participants
Interval 5.6 to 34.7
|
27.6 percentage of participants
Interval 12.7 to 47.2
|
7.1 percentage of participants
Interval 0.9 to 23.5
|
27.6 percentage of participants
Interval 12.7 to 47.2
|
36.7 percentage of participants
Interval 19.9 to 56.1
|
23.3 percentage of participants
Interval 9.9 to 42.3
|
16.7 percentage of participants
Interval 5.6 to 34.7
|
46.9 percentage of participants
Interval 29.1 to 65.3
|
14.3 percentage of participants
Interval 4.0 to 32.7
|
30.0 percentage of participants
Interval 14.7 to 49.4
|
16.7 percentage of participants
Interval 4.7 to 37.4
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
41.4 percentage of participants
Interval 23.5 to 61.1
|
33.3 percentage of participants
Interval 16.5 to 54.0
|
|
Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.9
|
0 percentage of participants
Interval 0.0 to 12.8
|
0 percentage of participants
Interval 0.0 to 11.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.2
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
0 percentage of participants
Interval 0.0 to 12.8
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
0 percentage of participants
Interval 0.0 to 14.2
|
78.6 percentage of participants
Interval 59.0 to 91.7
|
86.2 percentage of participants
Interval 68.3 to 96.1
|
70.0 percentage of participants
Interval 50.6 to 85.3
|
|
Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
50.0 percentage of participants
Interval 31.3 to 68.7
|
65.5 percentage of participants
Interval 45.7 to 82.1
|
46.4 percentage of participants
Interval 27.5 to 66.1
|
41.4 percentage of participants
Interval 23.5 to 61.1
|
83.3 percentage of participants
Interval 65.3 to 94.4
|
71.0 percentage of participants
Interval 52.0 to 85.8
|
33.3 percentage of participants
Interval 17.3 to 52.8
|
71.9 percentage of participants
Interval 53.3 to 86.3
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
73.3 percentage of participants
Interval 54.1 to 87.7
|
54.2 percentage of participants
Interval 32.8 to 74.4
|
78.6 percentage of participants
Interval 59.0 to 91.7
|
72.4 percentage of participants
Interval 52.8 to 87.3
|
63.3 percentage of participants
Interval 43.9 to 80.1
|
|
Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)
|
20.7 percentage of participants
Interval 8.0 to 39.7
|
32.1 percentage of participants
Interval 15.9 to 52.4
|
10.7 percentage of participants
Interval 2.3 to 28.2
|
27.6 percentage of participants
Interval 12.7 to 47.2
|
20.0 percentage of participants
Interval 7.7 to 38.6
|
17.2 percentage of participants
Interval 5.8 to 35.8
|
17.2 percentage of participants
Interval 5.8 to 35.8
|
21.9 percentage of participants
Interval 9.3 to 40.0
|
10.7 percentage of participants
Interval 2.3 to 28.2
|
13.3 percentage of participants
Interval 3.8 to 30.7
|
8.3 percentage of participants
Interval 1.0 to 27.0
|
28.6 percentage of participants
Interval 13.2 to 48.7
|
27.6 percentage of participants
Interval 12.7 to 47.2
|
21.4 percentage of participants
Interval 8.3 to 41.0
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Days 28, 56, 208 and 393Population: Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)
|
798.9 titer
Standard Deviation 4.66
|
737.9 titer
Standard Deviation 4.42
|
548.5 titer
Standard Deviation 4.47
|
806.6 titer
Standard Deviation 5.36
|
573.6 titer
Standard Deviation 3.08
|
514.6 titer
Standard Deviation 5.19
|
910.4 titer
Standard Deviation 4.37
|
821.5 titer
Standard Deviation 4.84
|
638.5 titer
Standard Deviation 3.90
|
780.6 titer
Standard Deviation 5.11
|
889.7 titer
Standard Deviation 5.34
|
14488.6 titer
Standard Deviation 3.00
|
20839.2 titer
Standard Deviation 1.96
|
15967.7 titer
Standard Deviation 2.39
|
|
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)
|
14417.7 titer
Standard Deviation 2.74
|
14171.3 titer
Standard Deviation 2.76
|
17504.8 titer
Standard Deviation 2.64
|
14220.4 titer
Standard Deviation 3.23
|
13982.2 titer
Standard Deviation 2.33
|
18266.0 titer
Standard Deviation 1.99
|
16082.5 titer
Standard Deviation 2.07
|
15974.2 titer
Standard Deviation 3.95
|
25808.9 titer
Standard Deviation 2.55
|
15466.3 titer
Standard Deviation 2.59
|
14045.2 titer
Standard Deviation 2.94
|
12613.2 titer
Standard Deviation 2.46
|
17696.3 titer
Standard Deviation 1.92
|
12235.7 titer
Standard Deviation 2.11
|
|
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)
|
3886.0 titer
Standard Deviation 2.98
|
3179.7 titer
Standard Deviation 2.78
|
4470.4 titer
Standard Deviation 2.55
|
5009.0 titer
Standard Deviation 2.80
|
3209.6 titer
Standard Deviation 2.54
|
3874.5 titer
Standard Deviation 2.55
|
4940.3 titer
Standard Deviation 2.48
|
4773.3 titer
Standard Deviation 2.62
|
5550.1 titer
Standard Deviation 2.70
|
3542.9 titer
Standard Deviation 2.54
|
3960.0 titer
Standard Deviation 2.55
|
4715.8 titer
Standard Deviation 2.51
|
5686.7 titer
Standard Deviation 2.17
|
4404.7 titer
Standard Deviation 2.19
|
|
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)
|
833.4 titer
Standard Deviation 4.64
|
790.3 titer
Standard Deviation 4.50
|
636.7 titer
Standard Deviation 4.60
|
647.6 titer
Standard Deviation 5.17
|
625.3 titer
Standard Deviation 2.96
|
520.3 titer
Standard Deviation 4.99
|
890.5 titer
Standard Deviation 4.75
|
842.9 titer
Standard Deviation 4.92
|
677.2 titer
Standard Deviation 3.75
|
827.3 titer
Standard Deviation 4.82
|
856.7 titer
Standard Deviation 5.34
|
741.5 titer
Standard Deviation 5.28
|
897.5 titer
Standard Deviation 3.74
|
742.7 titer
Standard Deviation 3.69
|
|
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)
|
5725.2 titer
Standard Deviation 2.37
|
5069.7 titer
Standard Deviation 2.48
|
6084.3 titer
Standard Deviation 2.43
|
5613.9 titer
Standard Deviation 2.68
|
4467.6 titer
Standard Deviation 2.05
|
5106.4 titer
Standard Deviation 2.06
|
5660.5 titer
Standard Deviation 2.22
|
7174.8 titer
Standard Deviation 2.47
|
7542.0 titer
Standard Deviation 2.28
|
5361.1 titer
Standard Deviation 2.37
|
5162.8 titer
Standard Deviation 2.18
|
6863.9 titer
Standard Deviation 2.27
|
7459.1 titer
Standard Deviation 1.72
|
5912.6 titer
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Days 28, 56, 208 and 393Population: Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)
|
1106.6 titer
Standard Deviation 4.68
|
1249.2 titer
Standard Deviation 3.45
|
1477.7 titer
Standard Deviation 4.13
|
1109.2 titer
Standard Deviation 4.10
|
921.7 titer
Standard Deviation 3.15
|
1130.9 titer
Standard Deviation 4.18
|
1340.4 titer
Standard Deviation 4.08
|
1238.6 titer
Standard Deviation 3.92
|
1201.2 titer
Standard Deviation 3.57
|
1473.2 titer
Standard Deviation 3.88
|
1832.3 titer
Standard Deviation 2.69
|
977.7 titer
Standard Deviation 3.73
|
1324.4 titer
Standard Deviation 3.34
|
1647.0 titer
Standard Deviation 3.39
|
|
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)
|
4595.7 titer
Standard Deviation 3.00
|
8636.7 titer
Standard Deviation 2.05
|
5750.4 titer
Standard Deviation 2.15
|
4391.5 titer
Standard Deviation 2.66
|
7545.2 titer
Standard Deviation 2.61
|
7802.7 titer
Standard Deviation 2.03
|
3444.6 titer
Standard Deviation 2.92
|
9945.7 titer
Standard Deviation 2.98
|
5129.9 titer
Standard Deviation 2.91
|
10624.2 titer
Standard Deviation 2.15
|
10034.2 titer
Standard Deviation 1.96
|
6622.0 titer
Standard Deviation 2.22
|
9995.5 titer
Standard Deviation 2.13
|
8164.0 titer
Standard Deviation 2.32
|
|
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)
|
2341.2 titer
Standard Deviation 3.93
|
3653.0 titer
Standard Deviation 2.24
|
2993.2 titer
Standard Deviation 3.61
|
2887.7 titer
Standard Deviation 2.78
|
2984.6 titer
Standard Deviation 2.62
|
3212.2 titer
Standard Deviation 2.44
|
2251.1 titer
Standard Deviation 3.15
|
5017.6 titer
Standard Deviation 2.82
|
2615.1 titer
Standard Deviation 2.91
|
4531.4 titer
Standard Deviation 2.21
|
4667.0 titer
Standard Deviation 2.20
|
3837.9 titer
Standard Deviation 2.30
|
4693.8 titer
Standard Deviation 2.52
|
4546.8 titer
Standard Deviation 2.26
|
|
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)
|
2236.5 titer
Standard Deviation 3.84
|
3103.0 titer
Standard Deviation 3.03
|
2450.2 titer
Standard Deviation 2.87
|
2175.3 titer
Standard Deviation 2.91
|
1946.4 titer
Standard Deviation 2.51
|
2173.7 titer
Standard Deviation 2.73
|
2267.2 titer
Standard Deviation 3.29
|
2969.9 titer
Standard Deviation 2.92
|
1898.2 titer
Standard Deviation 3.41
|
2550.0 titer
Standard Deviation 2.29
|
2871.1 titer
Standard Deviation 2.43
|
2425.1 titer
Standard Deviation 2.46
|
3133.0 titer
Standard Deviation 2.50
|
3060.7 titer
Standard Deviation 2.44
|
|
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)
|
1016.8 titer
Standard Deviation 5.56
|
1232.6 titer
Standard Deviation 3.46
|
1540.6 titer
Standard Deviation 3.83
|
1110.4 titer
Standard Deviation 3.84
|
839.4 titer
Standard Deviation 3.04
|
1097.8 titer
Standard Deviation 4.14
|
1268.1 titer
Standard Deviation 3.68
|
1311.0 titer
Standard Deviation 3.98
|
1139.9 titer
Standard Deviation 3.48
|
1494.7 titer
Standard Deviation 3.05
|
1924.8 titer
Standard Deviation 2.52
|
8459.4 titer
Standard Deviation 2.19
|
12901.7 titer
Standard Deviation 2.12
|
11116.3 titer
Standard Deviation 2.55
|
SECONDARY outcome
Timeframe: Days 28, 56, 208 and 393Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=24 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
|
1.0 ratio
Standard Deviation 1.13
|
0.9 ratio
Standard Deviation 1.18
|
0.8 ratio
Standard Deviation 1.50
|
1.2 ratio
Standard Deviation 2.85
|
0.9 ratio
Standard Deviation 1.26
|
1.0 ratio
Standard Deviation 1.16
|
1.0 ratio
Standard Deviation 1.36
|
1.0 ratio
Standard Deviation 1.18
|
0.9 ratio
Standard Deviation 1.28
|
0.9 ratio
Standard Deviation 1.28
|
1.0 ratio
Standard Deviation 1.58
|
19.5 ratio
Standard Deviation 3.73
|
23.2 ratio
Standard Deviation 3.00
|
22.0 ratio
Standard Deviation 2.57
|
|
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)
|
4.4 ratio
Standard Deviation 3.27
|
4.1 ratio
Standard Deviation 4.46
|
7.0 ratio
Standard Deviation 3.56
|
8.0 ratio
Standard Deviation 4.65
|
5.1 ratio
Standard Deviation 2.41
|
7.4 ratio
Standard Deviation 3.36
|
5.3 ratio
Standard Deviation 3.40
|
5.7 ratio
Standard Deviation 3.41
|
7.8 ratio
Standard Deviation 2.87
|
4.3 ratio
Standard Deviation 2.58
|
4.0 ratio
Standard Deviation 3.08
|
6.4 ratio
Standard Deviation 4.07
|
6.3 ratio
Standard Deviation 2.95
|
6.1 ratio
Standard Deviation 2.85
|
|
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
17.3 ratio
Standard Deviation 3.69
|
18.8 ratio
Standard Deviation 3.46
|
25.8 ratio
Standard Deviation 3.09
|
22.4 ratio
Standard Deviation 4.38
|
22.4 ratio
Standard Deviation 3.02
|
35.1 ratio
Standard Deviation 3.88
|
18.1 ratio
Standard Deviation 4.35
|
19.0 ratio
Standard Deviation 3.67
|
36.5 ratio
Standard Deviation 4.85
|
18.7 ratio
Standard Deviation 3.31
|
13.5 ratio
Standard Deviation 3.07
|
17.0 ratio
Standard Deviation 3.63
|
19.7 ratio
Standard Deviation 2.78
|
16.8 ratio
Standard Deviation 2.74
|
|
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)
|
6.9 ratio
Standard Deviation 3.63
|
6.7 ratio
Standard Deviation 3.71
|
9.3 ratio
Standard Deviation 3.77
|
9.0 ratio
Standard Deviation 4.32
|
7.1 ratio
Standard Deviation 2.63
|
10.4 ratio
Standard Deviation 3.79
|
6.4 ratio
Standard Deviation 3.62
|
8.5 ratio
Standard Deviation 3.90
|
10.7 ratio
Standard Deviation 3.00
|
6.5 ratio
Standard Deviation 2.96
|
5.2 ratio
Standard Deviation 3.27
|
9.3 ratio
Standard Deviation 3.57
|
8.3 ratio
Standard Deviation 2.79
|
7.8 ratio
Standard Deviation 3.52
|
SECONDARY outcome
Timeframe: Days 28, 56, 208 and 393Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=24 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
|
0.9 ratio
Standard Deviation 1.56
|
1.0 ratio
Standard Deviation 1.14
|
1.0 ratio
Standard Deviation 1.23
|
1.0 ratio
Standard Deviation 1.21
|
0.9 ratio
Standard Deviation 1.18
|
1.0 ratio
Standard Deviation 1.13
|
0.9 ratio
Standard Deviation 1.37
|
1.1 ratio
Standard Deviation 1.57
|
1.0 ratio
Standard Deviation 1.17
|
1.0 ratio
Standard Deviation 1.58
|
1.0 ratio
Standard Deviation 1.25
|
8.7 ratio
Standard Deviation 3.25
|
9.7 ratio
Standard Deviation 3.02
|
6.7 ratio
Standard Deviation 3.11
|
|
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
4.2 ratio
Standard Deviation 3.11
|
7.2 ratio
Standard Deviation 2.98
|
4.0 ratio
Standard Deviation 2.66
|
4.1 ratio
Standard Deviation 2.97
|
8.2 ratio
Standard Deviation 2.72
|
6.9 ratio
Standard Deviation 3.31
|
2.6 ratio
Standard Deviation 2.60
|
8.0 ratio
Standard Deviation 3.36
|
4.0 ratio
Standard Deviation 3.00
|
7.2 ratio
Standard Deviation 3.38
|
4.7 ratio
Standard Deviation 1.97
|
6.8 ratio
Standard Deviation 2.99
|
7.5 ratio
Standard Deviation 2.74
|
5.0 ratio
Standard Deviation 2.70
|
|
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)
|
2.1 ratio
Standard Deviation 2.45
|
3.0 ratio
Standard Deviation 2.74
|
1.9 ratio
Standard Deviation 1.96
|
2.6 ratio
Standard Deviation 2.50
|
3.2 ratio
Standard Deviation 2.36
|
2.7 ratio
Standard Deviation 2.21
|
1.7 ratio
Standard Deviation 2.17
|
4.1 ratio
Standard Deviation 2.45
|
2.0 ratio
Standard Deviation 2.06
|
3.1 ratio
Standard Deviation 2.61
|
2.2 ratio
Standard Deviation 1.92
|
3.9 ratio
Standard Deviation 2.70
|
3.5 ratio
Standard Deviation 2.24
|
2.5 ratio
Standard Deviation 2.57
|
|
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)
|
1.9 ratio
Standard Deviation 2.77
|
2.6 ratio
Standard Deviation 3.20
|
1.7 ratio
Standard Deviation 2.41
|
2.0 ratio
Standard Deviation 2.33
|
2.1 ratio
Standard Deviation 2.34
|
1.9 ratio
Standard Deviation 1.99
|
1.6 ratio
Standard Deviation 2.46
|
2.4 ratio
Standard Deviation 2.40
|
1.5 ratio
Standard Deviation 2.27
|
1.7 ratio
Standard Deviation 2.41
|
1.4 ratio
Standard Deviation 2.27
|
2.5 ratio
Standard Deviation 2.60
|
2.4 ratio
Standard Deviation 2.22
|
1.7 ratio
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: Baseline and Days 28, 56, 208 and 393Population: Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.2
|
3.03 percentage of participants
Interval 0.1 to 17.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 12.3
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 12.8
|
71.4 percentage of participants
Interval 51.3 to 86.8
|
72.4 percentage of participants
Interval 52.8 to 87.3
|
64.5 percentage of participants
Interval 45.4 to 80.8
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)
|
53.3 percentage of participants
Interval 34.3 to 71.7
|
58.6 percentage of participants
Interval 38.9 to 76.5
|
39.3 percentage of participants
Interval 21.5 to 59.4
|
45.2 percentage of participants
Interval 27.3 to 64.0
|
70.0 percentage of participants
Interval 50.6 to 85.3
|
58.1 percentage of participants
Interval 39.1 to 75.5
|
36.7 percentage of participants
Interval 19.9 to 56.1
|
65.6 percentage of participants
Interval 46.8 to 81.4
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
66.7 percentage of participants
Interval 47.2 to 82.7
|
50.0 percentage of participants
Interval 29.9 to 70.1
|
57.1 percentage of participants
Interval 37.2 to 75.5
|
51.7 percentage of participants
Interval 32.5 to 70.6
|
46.7 percentage of participants
Interval 28.3 to 65.7
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
30.0 percentage of participants
Interval 14.7 to 49.4
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
25.0 percentage of participants
Interval 11.5 to 43.4
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
13.3 percentage of participants
Interval 3.8 to 30.7
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
6.5 percentage of participants
Interval 0.8 to 21.4
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
SECONDARY outcome
Timeframe: Baseline and Days 28, 56, 208 and 393Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=24 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
80.0 percentage of participants
Interval 61.4 to 92.3
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
71.9 percentage of participants
Interval 53.3 to 86.3
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.9
|
0 percentage of participants
Interval 0.0 to 12.8
|
6.9 percentage of participants
Interval 0.8 to 22.8
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.2
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 12.8
|
0 percentage of participants
Interval 0.0 to 11.6
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
100.0 percentage of participants
Interval 88.1 to 100.0
|
100.0 percentage of participants
Interval 88.4 to 100.0
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
93.3 percentage of participants
Interval 77.9 to 99.2
|
89.7 percentage of participants
Interval 72.6 to 97.8
|
100.0 percentage of participants
Interval 87.7 to 100.0
|
89.7 percentage of participants
Interval 72.6 to 97.8
|
96.7 percentage of participants
Interval 82.8 to 99.9
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
90.0 percentage of participants
Interval 73.5 to 97.9
|
90.6 percentage of participants
Interval 75.0 to 98.0
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
100.0 percentage of participants
Interval 88.4 to 100.0
|
87.5 percentage of participants
Interval 67.6 to 97.3
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
100.0 percentage of participants
Interval 88.1 to 100.0
|
100.0 percentage of participants
Interval 88.4 to 100.0
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
73.3 percentage of participants
Interval 54.1 to 87.7
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
54.8 percentage of participants
Interval 36.0 to 72.7
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
SECONDARY outcome
Timeframe: Baseline and Days 28, 56, 208 and 393Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
The percentage of participants with a 4-fold rise from or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=24 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.9
|
0 percentage of participants
Interval 0.0 to 12.8
|
0 percentage of participants
Interval 0.0 to 11.7
|
0 percentage of participants
Interval 0.0 to 11.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
0 percentage of participants
Interval 0.0 to 12.8
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
0 percentage of participants
Interval 0.0 to 14.2
|
75.0 percentage of participants
Interval 55.1 to 89.3
|
72.4 percentage of participants
Interval 52.8 to 87.3
|
63.3 percentage of participants
Interval 43.9 to 80.1
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
23.3 percentage of participants
Interval 9.9 to 42.3
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
16.1 percentage of participants
Interval 5.5 to 33.7
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
53.3 percentage of participants
Interval 34.3 to 71.7
|
65.5 percentage of participants
Interval 45.7 to 82.1
|
39.3 percentage of participants
Interval 21.5 to 59.4
|
51.7 percentage of participants
Interval 32.5 to 70.6
|
73.3 percentage of participants
Interval 54.1 to 87.7
|
58.1 percentage of participants
Interval 39.1 to 75.5
|
36.7 percentage of participants
Interval 19.9 to 56.1
|
68.8 percentage of participants
Interval 50.0 to 83.9
|
46.4 percentage of participants
Interval 27.5 to 66.1
|
66.7 percentage of participants
Interval 47.2 to 82.7
|
54.2 percentage of participants
Interval 32.8 to 74.4
|
60.7 percentage of participants
Interval 40.6 to 78.5
|
51.7 percentage of participants
Interval 32.5 to 70.6
|
46.7 percentage of participants
Interval 28.3 to 65.7
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
36.7 percentage of participants
Interval 19.9 to 56.1
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
34.4 percentage of participants
Interval 18.6 to 53.2
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
NA percentage of participants
Data not collected
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Days 28, 56, 208 and 393Population: Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)
|
52.9 titer
Standard Deviation 4.86
|
37.4 titer
Standard Deviation 3.59
|
42.1 titer
Standard Deviation 3.63
|
32.1 titer
Standard Deviation 5.26
|
30.1 titer
Standard Deviation 3.26
|
44.5 titer
Standard Deviation 6.06
|
53.6 titer
Standard Deviation 5.76
|
60.1 titer
Standard Deviation 6.45
|
36.8 titer
Standard Deviation 5.30
|
58.5 titer
Standard Deviation 4.08
|
47.0 titer
Standard Deviation 4.91
|
73.3 titer
Standard Deviation 5.24
|
40.8 titer
Standard Deviation 4.25
|
41.5 titer
Standard Deviation 3.74
|
|
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30
|
1358.4 titer
Standard Deviation 4.02
|
996.2 titer
Standard Deviation 5.02
|
2223.3 titer
Standard Deviation 2.91
|
1068.7 titer
Standard Deviation 5.39
|
1368.6 titer
Standard Deviation 3.99
|
1849.8 titer
Standard Deviation 3.35
|
1594.9 titer
Standard Deviation 4.87
|
1435.5 titer
Standard Deviation 7.02
|
2074.3 titer
Standard Deviation 4.40
|
1510.6 titer
Standard Deviation 4.45
|
1131.2 titer
Standard Deviation 4.28
|
810.7 titer
Standard Deviation 5.58
|
922.6 titer
Standard Deviation 3.73
|
848.2 titer
Standard Deviation 3.63
|
|
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)
|
48.9 titer
Standard Deviation 4.99
|
34.6 titer
Standard Deviation 3.38
|
41.2 titer
Standard Deviation 3.85
|
41.0 titer
Standard Deviation 4.38
|
29.4 titer
Standard Deviation 3.31
|
46.2 titer
Standard Deviation 6.22
|
54.4 titer
Standard Deviation 5.67
|
59.8 titer
Standard Deviation 6.23
|
37.8 titer
Standard Deviation 5.20
|
56.3 titer
Standard Deviation 3.95
|
57.0 titer
Standard Deviation 5.31
|
1649.9 titer
Standard Deviation 4.88
|
2148.2 titer
Standard Deviation 2.98
|
1703.2 titer
Standard Deviation 2.62
|
|
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
302.5 titer
Standard Deviation 4.10
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
512.4 titer
Standard Deviation 5.85
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
|
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
224.0 titer
Standard Deviation 2.73
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
340.1 titer
Standard Deviation 3.91
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Days 28, 56, 208 and 393Population: Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)
|
495.7 titer
Standard Deviation 3.30
|
840.8 titer
Standard Deviation 2.87
|
583.7 titer
Standard Deviation 2.34
|
467.9 titer
Standard Deviation 2.79
|
803.3 titer
Standard Deviation 3.24
|
714.2 titer
Standard Deviation 2.44
|
336.7 titer
Standard Deviation 3.74
|
1088.9 titer
Standard Deviation 3.72
|
513.9 titer
Standard Deviation 3.82
|
1117.7 titer
Standard Deviation 3.03
|
1027.3 titer
Standard Deviation 2.36
|
578.8 titer
Standard Deviation 3.11
|
552.2 titer
Standard Deviation 2.60
|
691.2 titer
Standard Deviation 3.12
|
|
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)
|
83.4 titer
Standard Deviation 6.63
|
113.6 titer
Standard Deviation 4.43
|
145.5 titer
Standard Deviation 4.72
|
119.5 titer
Standard Deviation 4.47
|
72.8 titer
Standard Deviation 4.64
|
114.6 titer
Standard Deviation 4.56
|
100.2 titer
Standard Deviation 4.47
|
133.0 titer
Standard Deviation 4.77
|
114.3 titer
Standard Deviation 4.65
|
158.5 titer
Standard Deviation 3.41
|
201.7 titer
Standard Deviation 3.30
|
105.9 titer
Standard Deviation 4.08
|
121.9 titer
Standard Deviation 4.16
|
174.5 titer
Standard Deviation 4.13
|
|
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)
|
77.8 titer
Standard Deviation 6.49
|
110.0 titer
Standard Deviation 4.31
|
151.2 titer
Standard Deviation 4.70
|
125.3 titer
Standard Deviation 4.34
|
73.8 titer
Standard Deviation 4.42
|
116.3 titer
Standard Deviation 4.49
|
106.3 titer
Standard Deviation 4.05
|
139.2 titer
Standard Deviation 5.48
|
106.3 titer
Standard Deviation 4.71
|
164.8 titer
Standard Deviation 3.16
|
218.8 titer
Standard Deviation 3.07
|
953.5 titer
Standard Deviation 2.83
|
948.2 titer
Standard Deviation 2.52
|
1118.0 titer
Standard Deviation 2.91
|
|
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
251.8 titer
Standard Deviation 3.94
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
427.9 titer
Standard Deviation 3.95
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
|
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
139.7 titer
Standard Deviation 4.07
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
273.4 titer
Standard Deviation 3.59
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
SECONDARY outcome
Timeframe: Days 28, 56, 208 and 393Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=24 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
|
0.9 ratio
Standard Deviation 1.52
|
0.9 ratio
Standard Deviation 1.49
|
1.0 ratio
Standard Deviation 1.23
|
1.3 ratio
Standard Deviation 2.65
|
1.0 ratio
Standard Deviation 1.23
|
1.0 ratio
Standard Deviation 1.14
|
1.0 ratio
Standard Deviation 1.44
|
1.0 ratio
Standard Deviation 1.10
|
1.0 ratio
Standard Deviation 1.13
|
1.0 ratio
Standard Deviation 1.46
|
1.2 ratio
Standard Deviation 1.86
|
22.5 ratio
Standard Deviation 2.95
|
52.7 ratio
Standard Deviation 2.79
|
42.3 ratio
Standard Deviation 2.39
|
|
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
25.7 ratio
Standard Deviation 4.46
|
28.0 ratio
Standard Deviation 4.40
|
49.2 ratio
Standard Deviation 2.81
|
34.2 ratio
Standard Deviation 5.55
|
45.4 ratio
Standard Deviation 3.47
|
41.5 ratio
Standard Deviation 3.50
|
29.8 ratio
Standard Deviation 4.63
|
23.9 ratio
Standard Deviation 4.13
|
52.1 ratio
Standard Deviation 3.61
|
25.8 ratio
Standard Deviation 3.15
|
20.8 ratio
Standard Deviation 2.77
|
11.1 ratio
Standard Deviation 2.19
|
22.6 ratio
Standard Deviation 2.29
|
21.1 ratio
Standard Deviation 2.81
|
|
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
10.0 ratio
Standard Deviation 2.89
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
8.5 ratio
Standard Deviation 3.77
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
|
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
7.4 ratio
Standard Deviation 2.41
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
5.2 ratio
Standard Deviation 3.34
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
SECONDARY outcome
Timeframe: Days 28, 56, 208 and 393Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=24 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
|
0.9 ratio
Standard Deviation 1.33
|
1.0 ratio
Standard Deviation 1.42
|
1.0 ratio
Standard Deviation 1.13
|
1.1 ratio
Standard Deviation 1.27
|
1.0 ratio
Standard Deviation 1.14
|
1.0 ratio
Standard Deviation 1.09
|
1.1 ratio
Standard Deviation 1.44
|
1.0 ratio
Standard Deviation 1.60
|
1.0 ratio
Standard Deviation 1.10
|
1.0 ratio
Standard Deviation 1.36
|
1.0 ratio
Standard Deviation 1.22
|
9.0 ratio
Standard Deviation 2.85
|
7.8 ratio
Standard Deviation 2.89
|
6.3 ratio
Standard Deviation 3.11
|
|
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
5.9 ratio
Standard Deviation 4.37
|
7.7 ratio
Standard Deviation 3.92
|
3.6 ratio
Standard Deviation 2.45
|
4.2 ratio
Standard Deviation 2.54
|
11.0 ratio
Standard Deviation 3.48
|
6.2 ratio
Standard Deviation 3.36
|
3.4 ratio
Standard Deviation 2.70
|
8.2 ratio
Standard Deviation 3.36
|
4.0 ratio
Standard Deviation 3.14
|
7.1 ratio
Standard Deviation 2.81
|
4.9 ratio
Standard Deviation 2.35
|
5.5 ratio
Standard Deviation 4.74
|
4.5 ratio
Standard Deviation 2.53
|
3.9 ratio
Standard Deviation 2.41
|
|
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
3.5 ratio
Standard Deviation 2.67
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
3.2 ratio
Standard Deviation 2.44
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
|
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
1.9 ratio
Standard Deviation 2.47
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
1.9 ratio
Standard Deviation 2.26
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
NA ratio
Standard Deviation NA
Data not collected
|
SECONDARY outcome
Timeframe: Baseline and Days 28, 56, 208 and 393Population: Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 12.3
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 12.8
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
62.1 percentage of participants
Interval 42.3 to 79.3
|
67.7 percentage of participants
Interval 48.6 to 83.3
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)
|
33.3 percentage of participants
Interval 17.3 to 52.8
|
55.2 percentage of participants
Interval 35.7 to 73.6
|
32.1 percentage of participants
Interval 15.9 to 52.4
|
35.5 percentage of participants
Interval 19.2 to 54.6
|
66.7 percentage of participants
Interval 47.2 to 82.7
|
51.6 percentage of participants
Interval 33.1 to 69.8
|
26.7 percentage of participants
Interval 12.3 to 45.9
|
59.4 percentage of participants
Interval 40.6 to 76.3
|
28.6 percentage of participants
Interval 13.2 to 48.7
|
60.0 percentage of participants
Interval 40.6 to 77.3
|
53.8 percentage of participants
Interval 33.4 to 73.4
|
75.0 percentage of participants
Interval 55.1 to 89.3
|
58.6 percentage of participants
Interval 38.9 to 76.5
|
56.7 percentage of participants
Interval 37.4 to 74.5
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)
|
10.0 percentage of participants
Interval 2.1 to 26.5
|
20.7 percentage of participants
Interval 8.0 to 39.7
|
16.7 percentage of participants
Interval 5.6 to 34.7
|
6.5 percentage of participants
Interval 0.8 to 21.4
|
13.3 percentage of participants
Interval 3.8 to 30.7
|
13.3 percentage of participants
Interval 3.8 to 30.7
|
20.0 percentage of participants
Interval 7.7 to 38.6
|
31.3 percentage of participants
Interval 16.1 to 50.0
|
20.7 percentage of participants
Interval 8.0 to 39.7
|
16.7 percentage of participants
Interval 5.6 to 34.7
|
7.4 percentage of participants
Interval 0.9 to 24.3
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
34.5 percentage of participants
Interval 17.9 to 54.3
|
21.4 percentage of participants
Interval 8.3 to 41.0
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)
|
3.4 percentage of participants
Interval 0.1 to 17.8
|
13.8 percentage of participants
Interval 3.9 to 31.7
|
6.7 percentage of participants
Interval 0.8 to 22.1
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
6.7 percentage of participants
Interval 0.8 to 22.1
|
3.4 percentage of participants
Interval 0.1 to 17.8
|
6.9 percentage of participants
Interval 0.8 to 22.8
|
9.4 percentage of participants
Interval 2.0 to 25.0
|
3.4 percentage of participants
Interval 0.1 to 17.8
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
3.7 percentage of participants
Interval 0.1 to 19.0
|
7.1 percentage of participants
Interval 0.9 to 23.5
|
10.3 percentage of participants
Interval 2.2 to 27.4
|
7.1 percentage of participants
Interval 0.9 to 23.5
|
SECONDARY outcome
Timeframe: Baseline and Days 28, 56, 208 and 393Population: Per-Protocol Set included all participants who received both doses of study drug and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by HBGA binding assay. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=24 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.9
|
0 percentage of participants
Interval 0.0 to 12.8
|
0 percentage of participants
Interval 0.0 to 11.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 12.8
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 14.2
|
82.1 percentage of participants
Interval 63.1 to 93.9
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
93.3 percentage of participants
Interval 77.9 to 99.2
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
80.0 percentage of participants
Interval 61.4 to 92.3
|
79.3 percentage of participants
Interval 60.3 to 92.0
|
85.7 percentage of participants
Interval 67.3 to 96.0
|
82.8 percentage of participants
Interval 64.2 to 94.2
|
86.7 percentage of participants
Interval 69.3 to 96.2
|
87.1 percentage of participants
Interval 70.2 to 96.4
|
76.7 percentage of participants
Interval 57.7 to 90.1
|
78.1 percentage of participants
Interval 60.0 to 90.7
|
85.7 percentage of participants
Interval 67.3 to 96.0
|
90.0 percentage of participants
Interval 73.5 to 97.9
|
70.8 percentage of participants
Interval 48.9 to 87.4
|
100.0 percentage of participants
Interval 87.7 to 100.0
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
93.3 percentage of participants
Interval 77.9 to 99.2
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)
|
53.3 percentage of participants
Interval 34.3 to 71.7
|
65.5 percentage of participants
Interval 45.7 to 82.1
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
58.6 percentage of participants
Interval 38.9 to 76.5
|
43.3 percentage of participants
Interval 25.5 to 62.6
|
70.0 percentage of participants
Interval 50.6 to 85.3
|
60.0 percentage of participants
Interval 40.6 to 77.3
|
78.1 percentage of participants
Interval 60.0 to 90.7
|
82.1 percentage of participants
Interval 63.1 to 93.9
|
56.7 percentage of participants
Interval 37.4 to 74.5
|
33.3 percentage of participants
Interval 15.6 to 55.3
|
85.7 percentage of participants
Interval 67.3 to 96.0
|
93.1 percentage of participants
Interval 77.2 to 99.2
|
77.8 percentage of participants
Interval 57.7 to 91.4
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)
|
31.0 percentage of participants
Interval 15.3 to 50.8
|
32.1 percentage of participants
Interval 15.9 to 52.4
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
37.9 percentage of participants
Interval 20.7 to 57.7
|
23.3 percentage of participants
Interval 9.9 to 42.3
|
37.9 percentage of participants
Interval 20.7 to 57.7
|
44.8 percentage of participants
Interval 26.4 to 64.3
|
53.1 percentage of participants
Interval 34.7 to 70.9
|
53.6 percentage of participants
Interval 33.9 to 72.5
|
26.7 percentage of participants
Interval 12.3 to 45.9
|
29.2 percentage of participants
Interval 12.6 to 51.1
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
51.7 percentage of participants
Interval 32.5 to 70.6
|
46.4 percentage of participants
Interval 27.5 to 66.1
|
SECONDARY outcome
Timeframe: Baseline and Days 28, 56, 208 and 393Population: Per-Protocol Set included all participants who received both doses of study drug and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by HBGA binding assay. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=24 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
0 percentage of participants
Interval 0.0 to 11.9
|
3.7 percentage of participants
Interval 0.1 to 19.0
|
0 percentage of participants
Interval 0.0 to 11.9
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
3.7 percentage of participants
Interval 0.1 to 19.0
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
0 percentage of participants
Interval 0.0 to 14.2
|
82.1 percentage of participants
Interval 63.1 to 93.9
|
65.5 percentage of participants
Interval 45.7 to 82.1
|
70.0 percentage of participants
Interval 50.6 to 85.3
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
46.7 percentage of participants
Interval 28.3 to 65.7
|
72.4 percentage of participants
Interval 52.8 to 87.3
|
39.3 percentage of participants
Interval 21.5 to 59.4
|
41.4 percentage of participants
Interval 23.5 to 61.1
|
80.0 percentage of participants
Interval 61.4 to 92.3
|
61.3 percentage of participants
Interval 42.2 to 78.2
|
26.7 percentage of participants
Interval 12.3 to 45.9
|
71.9 percentage of participants
Interval 53.3 to 86.3
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
63.3 percentage of participants
Interval 43.9 to 80.1
|
66.7 percentage of participants
Interval 44.7 to 84.4
|
75.0 percentage of participants
Interval 55.1 to 89.3
|
58.6 percentage of participants
Interval 38.9 to 76.5
|
60.0 percentage of participants
Interval 40.6 to 77.3
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)
|
26.7 percentage of participants
Interval 12.3 to 45.9
|
31.0 percentage of participants
Interval 15.3 to 50.8
|
17.9 percentage of participants
Interval 6.1 to 36.9
|
20.7 percentage of participants
Interval 8.0 to 39.7
|
43.3 percentage of participants
Interval 25.5 to 62.6
|
20.0 percentage of participants
Interval 7.7 to 38.6
|
20.0 percentage of participants
Interval 7.7 to 38.6
|
43.8 percentage of participants
Interval 26.4 to 62.3
|
21.4 percentage of participants
Interval 8.3 to 41.0
|
33.3 percentage of participants
Interval 17.3 to 52.8
|
25.0 percentage of participants
Interval 9.8 to 46.7
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
37.9 percentage of participants
Interval 20.7 to 57.7
|
22.2 percentage of participants
Interval 8.6 to 42.3
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)
|
13.8 percentage of participants
Interval 3.9 to 31.7
|
21.4 percentage of participants
Interval 8.3 to 41.0
|
3.6 percentage of participants
Interval 0.1 to 18.3
|
17.2 percentage of participants
Interval 5.8 to 35.8
|
23.3 percentage of participants
Interval 9.9 to 42.3
|
3.4 percentage of participants
Interval 0.1 to 17.8
|
10.3 percentage of participants
Interval 2.2 to 27.4
|
12.5 percentage of participants
Interval 3.5 to 29.0
|
10.7 percentage of participants
Interval 2.3 to 28.2
|
16.7 percentage of participants
Interval 5.6 to 34.7
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
21.4 percentage of participants
Interval 8.3 to 41.0
|
24.1 percentage of participants
Interval 10.3 to 43.5
|
10.7 percentage of participants
Interval 2.3 to 28.2
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Days 28, 56, 208 and 393Population: Full Analysis Set included all participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)
|
130.0 titer
Standard Deviation 3.38
|
98.2 titer
Standard Deviation 3.46
|
159.0 titer
Standard Deviation 3.23
|
136.4 titer
Standard Deviation 3.67
|
80.1 titer
Standard Deviation 3.49
|
139.3 titer
Standard Deviation 2.68
|
159.8 titer
Standard Deviation 2.73
|
202.1 titer
Standard Deviation 3.34
|
208.6 titer
Standard Deviation 3.28
|
114.5 titer
Standard Deviation 2.89
|
107.9 titer
Standard Deviation 3.28
|
196.4 titer
Standard Deviation 2.86
|
219.2 titer
Standard Deviation 2.29
|
182.0 titer
Standard Deviation 2.40
|
|
Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)
|
280.5 titer
Standard Deviation 3.94
|
236.3 titer
Standard Deviation 4.61
|
403.3 titer
Standard Deviation 3.74
|
286.9 titer
Standard Deviation 5.01
|
22.86 titer
Standard Deviation 3.94
|
356.4 titer
Standard Deviation 3.74
|
400.1 titer
Standard Deviation 3.33
|
412.9 titer
Standard Deviation 4.78
|
510.0 titer
Standard Deviation 4.36
|
247.2 titer
Standard Deviation 3.43
|
271.3 titer
Standard Deviation 5.00
|
398.6 titer
Standard Deviation 2.70
|
463.5 titer
Standard Deviation 2.32
|
355.8 titer
Standard Deviation 2.58
|
|
Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)
|
24.8 titer
Standard Deviation 2.75
|
18.7 titer
Standard Deviation 1.85
|
26.0 titer
Standard Deviation 2.73
|
26.8 titer
Standard Deviation 3.35
|
19.1 titer
Standard Deviation 1.68
|
24.8 titer
Standard Deviation 2.31
|
30.5 titer
Standard Deviation 3.04
|
24.5 titer
Standard Deviation 2.59
|
23.8 titer
Standard Deviation 2.46
|
23.2 titer
Standard Deviation 2.19
|
26.3 titer
Standard Deviation 2.68
|
23.1 titer
Standard Deviation 2.25
|
22.3 titer
Standard Deviation 2.26
|
20.6 titer
Standard Deviation 2.04
|
|
Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)
|
25.0 titer
Standard Deviation 2.60
|
18.6 titer
Standard Deviation 1.86
|
23.8 titer
Standard Deviation 2.44
|
26.7 titer
Standard Deviation 3.19
|
18.6 titer
Standard Deviation 1.70
|
23.0 titer
Standard Deviation 2.24
|
27.3 titer
Standard Deviation 2.46
|
25.1 titer
Standard Deviation 2.52
|
25.5 titer
Standard Deviation 2.52
|
24.8 titer
Standard Deviation 2.37
|
28.5 titer
Standard Deviation 2.66
|
347.6 titer
Standard Deviation 4.62
|
385.9 titer
Standard Deviation 3.64
|
391.1 titer
Standard Deviation 3.56
|
|
Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)
|
67.8 titer
Standard Deviation 3.78
|
51.3 titer
Standard Deviation 3.23
|
88.1 titer
Standard Deviation 3.54
|
74.8 titer
Standard Deviation 4.26
|
44.0 titer
Standard Deviation 3.39
|
71.9 titer
Standard Deviation 3.40
|
91.5 titer
Standard Deviation 3.14
|
107.5 titer
Standard Deviation 3.97
|
99.6 titer
Standard Deviation 4.09
|
55.0 titer
Standard Deviation 3.22
|
66.1 titer
Standard Deviation 3.86
|
103.4 titer
Standard Deviation 3.95
|
113.6 titer
Standard Deviation 3.30
|
81.0 titer
Standard Deviation 2.85
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Days 28, 56, 208 and 393Population: Full Analysis Set included all participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)
|
66.0 titer
Standard Deviation 4.85
|
80.1 titer
Standard Deviation 3.44
|
115.3 titer
Standard Deviation 4.24
|
91.4 titer
Standard Deviation 4.15
|
60.9 titer
Standard Deviation 3.84
|
96.6 titer
Standard Deviation 4.03
|
80.7 titer
Standard Deviation 4.48
|
89.8 titer
Standard Deviation 4.41
|
96.2 titer
Standard Deviation 3.93
|
102.3 titer
Standard Deviation 3.39
|
121.9 titer
Standard Deviation 3.47
|
56.1 titer
Standard Deviation 3.48
|
92.0 titer
Standard Deviation 3.96
|
117.8 titer
Standard Deviation 3.91
|
|
Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)
|
69.3 titer
Standard Deviation 4.56
|
75.7 titer
Standard Deviation 3.63
|
124.9 titer
Standard Deviation 3.98
|
87.9 titer
Standard Deviation 3.75
|
67.7 titer
Standard Deviation 3.76
|
94.5 titer
Standard Deviation 4.30
|
74.6 titer
Standard Deviation 4.17
|
98.1 titer
Standard Deviation 5.11
|
92.9 titer
Standard Deviation 3.87
|
123.3 titer
Standard Deviation 3.25
|
117.6 titer
Standard Deviation 3.62
|
552.6 titer
Standard Deviation 3.65
|
688.4 titer
Standard Deviation 3.16
|
904.4 titer
Standard Deviation 2.67
|
|
Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)
|
336.9 titer
Standard Deviation 3.40
|
686.3 titer
Standard Deviation 3.47
|
429.0 titer
Standard Deviation 2.40
|
317.8 titer
Standard Deviation 2.94
|
675.7 titer
Standard Deviation 3.21
|
632.1 titer
Standard Deviation 2.11
|
189.2 titer
Standard Deviation 4.63
|
842.8 titer
Standard Deviation 3.23
|
360.1 titer
Standard Deviation 3.85
|
862.8 titer
Standard Deviation 3.12
|
778.0 titer
Standard Deviation 2.57
|
426.5 titer
Standard Deviation 3.46
|
596.3 titer
Standard Deviation 2.86
|
604.4 titer
Standard Deviation 2.91
|
|
Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)
|
186.7 titer
Standard Deviation 3.19
|
241.5 titer
Standard Deviation 3.24
|
244.6 titer
Standard Deviation 2.78
|
206.3 titer
Standard Deviation 2.84
|
229.9 titer
Standard Deviation 3.60
|
259.7 titer
Standard Deviation 2.66
|
142.5 titer
Standard Deviation 4.09
|
346.8 titer
Standard Deviation 2.92
|
201.0 titer
Standard Deviation 3.49
|
340.6 titer
Standard Deviation 2.60
|
324.6 titer
Standard Deviation 3.07
|
277.5 titer
Standard Deviation 2.53
|
350.9 titer
Standard Deviation 2.36
|
295.3 titer
Standard Deviation 3.07
|
|
Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)
|
120.5 titer
Standard Deviation 4.21
|
180.2 titer
Standard Deviation 3.95
|
123.5 titer
Standard Deviation 3.87
|
133.2 titer
Standard Deviation 3.81
|
104.7 titer
Standard Deviation 4.01
|
134.4 titer
Standard Deviation 3.74
|
109.3 titer
Standard Deviation 4.44
|
182.9 titer
Standard Deviation 3.60
|
121.9 titer
Standard Deviation 3.88
|
179.7 titer
Standard Deviation 2.53
|
209.0 titer
Standard Deviation 3.38
|
126.2 titer
Standard Deviation 3.56
|
171.2 titer
Standard Deviation 3.61
|
192.9 titer
Standard Deviation 3.52
|
SECONDARY outcome
Timeframe: Days 28, 56, 208 and 393Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=24 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)
|
2.7 titer
Standard Deviation 3.29
|
2.7 titer
Standard Deviation 2.71
|
3.3 titer
Standard Deviation 2.87
|
2.6 titer
Standard Deviation 2.97
|
2.3 titer
Standard Deviation 2.65
|
3.0 titer
Standard Deviation 2.35
|
2.9 titer
Standard Deviation 2.61
|
4.4 titer
Standard Deviation 3.30
|
4.0 titer
Standard Deviation 3.10
|
2.4 titer
Standard Deviation 2.35
|
2.4 titer
Standard Deviation 2.73
|
4.5 titer
Standard Deviation 3.29
|
5.1 titer
Standard Deviation 2.81
|
3.8 titer
Standard Deviation 2.60
|
|
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
|
1.0 titer
Standard Deviation 1.30
|
1.0 titer
Standard Deviation 1.08
|
0.9 titer
Standard Deviation 1.30
|
1.0 titer
Standard Deviation 1.21
|
1.0 titer
Standard Deviation 1.37
|
0.9 titer
Standard Deviation 1.26
|
0.9 titer
Standard Deviation 1.59
|
1.0 titer
Standard Deviation 1.22
|
1.1 titer
Standard Deviation 1.37
|
1.1 titer
Standard Deviation 1.28
|
1.0 titer
Standard Deviation 1.31
|
15.0 titer
Standard Deviation 3.80
|
17.3 titer
Standard Deviation 3.02
|
19.3 titer
Standard Deviation 3.33
|
|
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
11.3 titer
Standard Deviation 4.25
|
13.2 titer
Standard Deviation 4.31
|
14.9 titer
Standard Deviation 3.54
|
10.0 titer
Standard Deviation 4.07
|
12.0 titer
Standard Deviation 3.36
|
14.3 titer
Standard Deviation 2.98
|
13.1 titer
Standard Deviation 3.96
|
16.9 titer
Standard Deviation 4.60
|
21.1 titer
Standard Deviation 3.72
|
10.7 titer
Standard Deviation 2.53
|
9.7 titer
Standard Deviation 4.29
|
17.2 titer
Standard Deviation 2.36
|
20.8 titer
Standard Deviation 2.20
|
17.9 titer
Standard Deviation 2.68
|
|
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)
|
5.2 titer
Standard Deviation 3.41
|
5.5 titer
Standard Deviation 3.18
|
6.0 titer
Standard Deviation 2.97
|
4.8 titer
Standard Deviation 2.91
|
4.2 titer
Standard Deviation 2.94
|
5.9 titer
Standard Deviation 2.00
|
5.2 titer
Standard Deviation 2.69
|
8.2 titer
Standard Deviation 3.14
|
8.6 titer
Standard Deviation 2.63
|
4.9 titer
Standard Deviation 2.24
|
3.7 titer
Standard Deviation 2.95
|
8.5 titer
Standard Deviation 2.52
|
9.8 titer
Standard Deviation 2.18
|
7.9 titer
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: Days 28, 56, 208 and 393Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=24 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
|
1.1 titer
Standard Deviation 1.68
|
0.9 titer
Standard Deviation 1.59
|
1.0 titer
Standard Deviation 1.47
|
1.0 titer
Standard Deviation 1.73
|
1.1 titer
Standard Deviation 1.62
|
1.0 titer
Standard Deviation 1.38
|
0.9 titer
Standard Deviation 1.29
|
1.1 titer
Standard Deviation 1.89
|
1.0 titer
Standard Deviation 1.59
|
1.2 titer
Standard Deviation 2.45
|
1.0 titer
Standard Deviation 1.46
|
9.8 titer
Standard Deviation 3.48
|
7.5 titer
Standard Deviation 3.13
|
7.0 titer
Standard Deviation 2.96
|
|
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
5.1 titer
Standard Deviation 4.42
|
8.9 titer
Standard Deviation 3.31
|
3.6 titer
Standard Deviation 2.71
|
3.7 titer
Standard Deviation 3.43
|
11.1 titer
Standard Deviation 3.32
|
6.5 titer
Standard Deviation 3.33
|
2.3 titer
Standard Deviation 2.95
|
9.4 titer
Standard Deviation 3.95
|
3.5 titer
Standard Deviation 3.61
|
8.4 titer
Standard Deviation 3.59
|
6.0 titer
Standard Deviation 2.24
|
7.6 titer
Standard Deviation 3.19
|
6.5 titer
Standard Deviation 2.94
|
4.8 titer
Standard Deviation 2.46
|
|
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)
|
2.8 titer
Standard Deviation 3.10
|
3.1 titer
Standard Deviation 2.51
|
2.0 titer
Standard Deviation 2.42
|
2.4 titer
Standard Deviation 2.58
|
3.8 titer
Standard Deviation 2.56
|
2.5 titer
Standard Deviation 1.99
|
1.8 titer
Standard Deviation 2.27
|
3.9 titer
Standard Deviation 3.03
|
2.0 titer
Standard Deviation 2.30
|
3.3 titer
Standard Deviation 2.66
|
2.5 titer
Standard Deviation 1.73
|
4.9 titer
Standard Deviation 2.72
|
3.8 titer
Standard Deviation 2.81
|
2.5 titer
Standard Deviation 2.35
|
|
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)
|
1.7 titer
Standard Deviation 3.14
|
2.3 titer
Standard Deviation 2.42
|
1.0 titer
Standard Deviation 2.43
|
1.5 titer
Standard Deviation 2.56
|
1.7 titer
Standard Deviation 2.32
|
1.4 titer
Standard Deviation 1.82
|
1.3 titer
Standard Deviation 2.25
|
2.0 titer
Standard Deviation 2.59
|
1.3 titer
Standard Deviation 2.28
|
1.8 titer
Standard Deviation 2.11
|
1.6 titer
Standard Deviation 1.90
|
2.2 titer
Standard Deviation 2.70
|
1.9 titer
Standard Deviation 2.62
|
1.4 titer
Standard Deviation 2.23
|
SECONDARY outcome
Timeframe: Days 28, 56, 208 and 393Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
GMFR of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=24 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
|
1.0 titer
Standard Deviation 1.17
|
1.0 titer
Standard Deviation 1.18
|
0.9 titer
Standard Deviation 1.12
|
1.0 titer
Standard Deviation 1.22
|
1.0 titer
Standard Deviation 1.11
|
0.9 titer
Standard Deviation 1.22
|
0.9 titer
Standard Deviation 1.18
|
1.0 titer
Standard Deviation 1.67
|
0.9 titer
Standard Deviation 1.98
|
1.0 titer
Standard Deviation 1.12
|
1.0 titer
Standard Deviation 1.13
|
7.4 titer
Standard Deviation 2.97
|
4.5 titer
Standard Deviation 2.94
|
5.7 titer
Standard Deviation 3.01
|
|
GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
3.4 titer
Standard Deviation 2.91
|
5.1 titer
Standard Deviation 2.78
|
1.7 titer
Standard Deviation 1.81
|
2.6 titer
Standard Deviation 2.78
|
4.2 titer
Standard Deviation 3.20
|
3.7 titer
Standard Deviation 3.17
|
1.6 titer
Standard Deviation 2.06
|
5.9 titer
Standard Deviation 4.17
|
2.7 titer
Standard Deviation 3.16
|
4.6 titer
Standard Deviation 2.73
|
3.1 titer
Standard Deviation 2.36
|
4.6 titer
Standard Deviation 2.94
|
3.6 titer
Standard Deviation 2.62
|
4.0 titer
Standard Deviation 2.45
|
|
GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
1.8 titer
Standard Deviation 2.34
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
2.4 titer
Standard Deviation 2.89
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
|
GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)
D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
1.4 titer
Standard Deviation 2.08
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
1.9 titer
Standard Deviation 2.56
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
SECONDARY outcome
Timeframe: Days 28, 56, 208 and 393Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
GMFR of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=24 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
|
0.9 titer
Standard Deviation 1.22
|
1.0 titer
Standard Deviation 1.26
|
0.9 titer
Standard Deviation 1.12
|
1.0 titer
Standard Deviation 1.18
|
0.9 titer
Standard Deviation 1.22
|
1.0 titer
Standard Deviation 1.09
|
0.9 titer
Standard Deviation 1.47
|
1.1 titer
Standard Deviation 1.91
|
1.0 titer
Standard Deviation 1.05
|
1.0 titer
Standard Deviation 1.25
|
1.0 titer
Standard Deviation 1.06
|
2.2 titer
Standard Deviation 2.48
|
2.5 titer
Standard Deviation 2.80
|
2.8 titer
Standard Deviation 2.77
|
|
GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
1.5 titer
Standard Deviation 2.59
|
2.3 titer
Standard Deviation 2.10
|
1.3 titer
Standard Deviation 1.67
|
1.3 titer
Standard Deviation 1.48
|
2.0 titer
Standard Deviation 2.46
|
1.7 titer
Standard Deviation 1.82
|
1.1 titer
Standard Deviation 1.60
|
2.9 titer
Standard Deviation 3.50
|
1.6 titer
Standard Deviation 1.77
|
2.5 titer
Standard Deviation 2.62
|
2.0 titer
Standard Deviation 2.02
|
1.8 titer
Standard Deviation 2.25
|
1.9 titer
Standard Deviation 2.30
|
2.1 titer
Standard Deviation 2.25
|
|
GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
1.4 titer
Standard Deviation 1.93
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
1.6 titer
Standard Deviation 2.10
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
|
GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)
D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
1.0 titer
Standard Deviation 1.78
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
1.4 titer
Standard Deviation 2.28
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
SECONDARY outcome
Timeframe: Day 56Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.
GMFR of anti-norovirus Cross-Protection Assays: GII.2 EC50, GI.3 EC50 and GII.4.2012 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection Assays
GII.2 EC50
|
1.1 titer
Standard Deviation 1.92
|
0.8 titer
Standard Deviation 3.73
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection Assays
GI.3 EC50
|
5.9 titer
Standard Deviation 3.23
|
3.0 titer
Standard Deviation 3.36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection Assays
GII.4.2012 EC50
|
3.2 titer
Standard Deviation 2.50
|
4.1 titer
Standard Deviation 3.51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Days 28, 56, 208 and 393Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Blocking titers 50 (BT50) of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=24 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)
D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
63.7 titer
Standard Deviation 4.34
|
75.1 titer
Standard Deviation 3.85
|
114.7 titer
Standard Deviation 4.28
|
85.8 titer
Standard Deviation 4.19
|
63.0 titer
Standard Deviation 4.08
|
89.1 titer
Standard Deviation 4.13
|
99.8 titer
Standard Deviation 4.47
|
85.0 titer
Standard Deviation 4.64
|
91.8 titer
Standard Deviation 4.02
|
112.6 titer
Standard Deviation 3.26
|
134.8 titer
Standard Deviation 3.07
|
54.0 titer
Standard Deviation 3.95
|
81.8 titer
Standard Deviation 3.86
|
93.2 titer
Standard Deviation 3.75
|
|
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
|
63.6 titer
Standard Deviation 4.31
|
72.9 titer
Standard Deviation 3.95
|
113.8 titer
Standard Deviation 4.02
|
83.3 titer
Standard Deviation 4.05
|
61.7 titer
Standard Deviation 4.04
|
84.4 titer
Standard Deviation 4.23
|
90.5 titer
Standard Deviation 4.16
|
88.0 titer
Standard Deviation 5.49
|
78.6 titer
Standard Deviation 4.06
|
109.0 titer
Standard Deviation 3.25
|
130.6 titer
Standard Deviation 2.95
|
400.0 titer
Standard Deviation 3.57
|
366.9 titer
Standard Deviation 4.60
|
534.2 titer
Standard Deviation 3.17
|
|
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
217.3 titer
Standard Deviation 3.57
|
380.7 titer
Standard Deviation 3.61
|
200.3 titer
Standard Deviation 4.33
|
221.0 titer
Standard Deviation 3.66
|
263.7 titer
Standard Deviation 5.77
|
327.5 titer
Standard Deviation 4.12
|
161.5 titer
Standard Deviation 4.66
|
501.4 titer
Standard Deviation 5.07
|
248.5 titer
Standard Deviation 4.56
|
518.8 titer
Standard Deviation 3.40
|
415.5 titer
Standard Deviation 4.11
|
248.3 titer
Standard Deviation 4.01
|
296.5 titer
Standard Deviation 4.12
|
373.4 titer
Standard Deviation 3.40
|
|
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
113.5 titer
Standard Deviation 5.03
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
202.5 titer
Standard Deviation 4.06
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
|
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)
D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
88.9 titer
Standard Deviation 3.90
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
160.8 titer
Standard Deviation 3.96
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Days 28, 56, 208 and 393Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Blocking Titers 50 (BT50) of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=28 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=24 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=30 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
53.5 titer
Standard Deviation 3.93
|
59.3 titer
Standard Deviation 2.79
|
56.7 titer
Standard Deviation 3.06
|
40.6 titer
Standard Deviation 3.37
|
55.5 titer
Standard Deviation 3.33
|
62.1 titer
Standard Deviation 3.26
|
31.2 titer
Standard Deviation 3.04
|
80.6 titer
Standard Deviation 4.37
|
51.2 titer
Standard Deviation 3.31
|
70.4 titer
Standard Deviation 3.22
|
64.4 titer
Standard Deviation 3.52
|
38.8 titer
Standard Deviation 2.98
|
56.7 titer
Standard Deviation 3.15
|
79.1 titer
Standard Deviation 3.18
|
|
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
40.2 titer
Standard Deviation 3.14
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
44.2 titer
Standard Deviation 3.17
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
|
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)
D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
28.5 titer
Standard Deviation 2.37
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
38.3 titer
Standard Deviation 2.87
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
NA titer
Standard Deviation NA
Data not collected
|
|
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
|
32.6 titer
Standard Deviation 3.49
|
24.8 titer
Standard Deviation 2.29
|
42.5 titer
Standard Deviation 3.10
|
31.1 titer
Standard Deviation 3.12
|
26.4 titer
Standard Deviation 2.44
|
36.3 titer
Standard Deviation 3.09
|
25.9 titer
Standard Deviation 3.08
|
30.2 titer
Standard Deviation 3.87
|
32.9 titer
Standard Deviation 3.09
|
27.8 titer
Standard Deviation 2.28
|
31.8 titer
Standard Deviation 2.73
|
48.0 titer
Standard Deviation 3.37
|
75.1 titer
Standard Deviation 3.35
|
104.8 titer
Standard Deviation 3.35
|
|
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)
D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
|
35.0 titer
Standard Deviation 3.86
|
26.0 titer
Standard Deviation 2.30
|
43.3 titer
Standard Deviation 3.29
|
32.4 titer
Standard Deviation 3.24
|
28.3 titer
Standard Deviation 2.45
|
37.5 titer
Standard Deviation 3.18
|
29.7 titer
Standard Deviation 3.34
|
28.0 titer
Standard Deviation 2.93
|
32.2 titer
Standard Deviation 3.09
|
28.1 titer
Standard Deviation 2.31
|
32.3 titer
Standard Deviation 2.79
|
21.6 titer
Standard Deviation 2.11
|
29.7 titer
Standard Deviation 2.48
|
37.3 titer
Standard Deviation 3.42
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 56Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.
Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GII.2 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.2 EC50 (HBGA)
Day 1
|
266.2 titer
Standard Deviation 2.62
|
265.5 titer
Standard Deviation 4.79
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.2 EC50 (HBGA)
Day 56
|
295.8 titer
Standard Deviation 2.31
|
216.5 titer
Standard Deviation 4.46
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 56Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.
Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GI.3 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GI.3 EC50 (HBGA)
Day 1
|
59.7 titer
Standard Deviation 2.98
|
74.1 titer
Standard Deviation 3.70
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GI.3 EC50 (HBGA)
Day 56
|
350.5 titer
Standard Deviation 3.05
|
222.7 titer
Standard Deviation 5.09
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 56Population: Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.
Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GII.4.2012 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only. D=Day
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.4.2012 EC50 (HBGA)
Day 1
|
45.5 titer
Standard Deviation 4.07
|
50.7 titer
Standard Deviation 5.10
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.4.2012 EC50 (HBGA)
Day 56
|
146.6 titer
Standard Deviation 3.11
|
208.5 titer
Standard Deviation 3.80
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Day 56Population: Safety Analysis Set included all participants who received at least one dose of trial vaccine.
Significant new medical conditions will be evaluated by the investigator for the co-existence of any of the following conditions: Adverse events of special interest (AESIs) are predefined events for potential immune mediated disorders. All AESIs are medically evaluated to assess if they might indicate an immune-mediated disorder. Immune mediated events (IMEs) are AEs that represent a new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment.
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Significant New Medical Conditions
AESIs
|
6.7 percentage of participants
|
3.3 percentage of participants
|
0 percentage of participants
|
6.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
7.1 percentage of participants
|
3.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Significant New Medical Conditions
IMEs
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 56Population: Safety Analysis Set included all participants who received at least one dose of trial vaccine.
Withdrawal due to an AE will occur if the participant experiences an AE that requires early termination because continued participation imposes an unacceptable risk to the participant's health or the participants is unwilling to continue because of the AE.
Outcome measures
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 Participants
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 Participants
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 Participants
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 Participants
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 Participants
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
GI.1/GII.4 (15/15) - MPL (50)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
GI.1/GII.4 (15/50) - MPL (50)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
GI.1/GII.4 (50/50) - MPL (50)
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
GI.1/GII.4 (15/15) - MPL (15)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
GI.1/GII.4 (15/50) - MPL (15)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
GI.1/GII.4 (50/50) - MPL (15)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
GI.1/GII.4 (15/15)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
GI.1/GII.4 (15/50)
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
GI.1/GII.4 (50/50)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
GI.1/GII.4 (50/150)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
GI.1/GII.4 (15/50) - Al(OH)3 (167)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
GI.1/GII.4 (15/50) x2
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
GI.1/GII.4 (50/150) x2
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GI.1/GII.4 (15/15) - MPL (50)
n=30 participants at risk
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 participants at risk
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 participants at risk
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 participants at risk
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 participants at risk
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Osteoarthritis
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
1/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Chondropathy
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Foot deformity
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Appendicitis
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
1/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Erysipelas
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
1/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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 bacterial
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Leptospirosis
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Meningitis aseptic
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Pneumonia
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Compression fracture
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Tendon injury
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Tendon rupture
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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 upper
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
1/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Intestinal polyp
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Large intestinal polyp
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
1/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Biliary colic
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
1/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Endocrine disorders
Goitre
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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)
Cervix carcinoma
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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)
Rectal adenocarcinoma
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Transient ischaemic attack
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Chronic obstructive pulmonary disease
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Pharyngeal abscess
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
1/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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 |
GI.1/GII.4 (15/15) - MPL (50)
n=30 participants at risk
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
|
GI.1/GII.4 (15/50) - MPL (50)
n=30 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (50)
n=30 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15) - MPL (15)
n=31 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - MPL (15)
n=30 participants at risk
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
|
GI.1/GII.4 (50/50) - MPL (15)
n=31 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/15)
n=30 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50)
n=32 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/50)
n=29 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (50/150)
n=30 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167)
n=29 participants at risk
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
|
GI.1/GII.4 (15/50) x2
n=28 participants at risk
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (50/150) x2
n=29 participants at risk
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
n=31 participants at risk
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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%
3/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.5%
2/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
2/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
1/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
4/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
1/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.7%
3/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
1/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
1/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
|
6.7%
2/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
2/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
2/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.9%
2/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
2/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
1/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
2/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.9%
2/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
1/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.5%
2/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
2/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
1/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
1/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.5%
2/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Fatigue
|
6.7%
2/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
2/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
2/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
1/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
2/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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 pain
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
2/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.5%
2/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.9%
2/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
1/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Influenza like illness
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
1/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.7%
3/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
1/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
1/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
Nasopharyngitis
|
10.0%
3/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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%
3/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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%
3/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
1/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
1/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
1/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.5%
2/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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%
3/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
26.7%
8/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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%
3/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.7%
3/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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%
3/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.7%
3/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
1/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.8%
4/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
2/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.9%
2/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.5%
2/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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%
3/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.5%
2/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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%
3/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
1/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.4%
3/32 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.3%
3/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
1/28 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.9%
2/29 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
1/31 • Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
At each visit the investigator had to document any occurrence of adverse events and 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 The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER