Trial Outcomes & Findings for Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in an Elderly Population (NCT NCT02661490)
NCT ID: NCT02661490
Last Updated: 2020-05-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
320 participants
Primary outcome timeframe
Day 57
Results posted on
2020-05-18
Participant Flow
Participants took part in the study at 10 investigative sites in United States from 1 February 2016 to 31 October 2017.
Healthy elderly volunteers were enrolled and randomized in 1:1:1:1 ratio in 4 arm groups to receive either one or two doses of one of the 2 formulations (A or B) of norovirus (NoV) GI.1/GII4 bivalent virus like particle (VLP) vaccine or placebo. Healthy young adults received both placebo and formulation A.
Participant milestones
| Measure |
Arm 1: NoV Vaccine Formulation A_1-Dose
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
Arm 2: NoV Vaccine Formulation A_2-Dose
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
76
|
74
|
72
|
72
|
26
|
|
Overall Study
COMPLETED
|
73
|
72
|
70
|
71
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
2
|
1
|
3
|
Reasons for withdrawal
| Measure |
Arm 1: NoV Vaccine Formulation A_1-Dose
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
Arm 2: NoV Vaccine Formulation A_2-Dose
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
0
|
0
|
|
Overall Study
Death
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Reason not Specified
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Data is reported for elderly participants only.
Baseline characteristics by cohort
| Measure |
Arm 1: NoV Vaccine Formulation A_1-Dose
n=76 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
Arm 2: NoV Vaccine Formulation A_2-Dose
n=74 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=72 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=26 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Total
n=320 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
78.0 years
STANDARD_DEVIATION 9.14 • n=76 Participants • Data is reported for elderly participants only.
|
77.4 years
STANDARD_DEVIATION 9.32 • n=74 Participants • Data is reported for elderly participants only.
|
76.7 years
STANDARD_DEVIATION 9.22 • n=72 Participants • Data is reported for elderly participants only.
|
77.7 years
STANDARD_DEVIATION 9.07 • n=72 Participants • Data is reported for elderly participants only.
|
34.6 years
STANDARD_DEVIATION 8.46 • n=26 Participants • Data is reported for young adult participants only.
|
34.6 years
STANDARD_DEVIATION 8.46 • n=26 Participants • Data is reported for young adult participants only.
|
|
Sex: Female, Male
Female
|
44 Participants
n=76 Participants
|
41 Participants
n=74 Participants
|
40 Participants
n=72 Participants
|
40 Participants
n=72 Participants
|
16 Participants
n=26 Participants
|
181 Participants
n=320 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=76 Participants
|
33 Participants
n=74 Participants
|
32 Participants
n=72 Participants
|
32 Participants
n=72 Participants
|
10 Participants
n=26 Participants
|
139 Participants
n=320 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=76 Participants
|
6 Participants
n=74 Participants
|
3 Participants
n=72 Participants
|
4 Participants
n=72 Participants
|
2 Participants
n=26 Participants
|
19 Participants
n=320 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=76 Participants
|
68 Participants
n=74 Participants
|
69 Participants
n=72 Participants
|
68 Participants
n=72 Participants
|
24 Participants
n=26 Participants
|
301 Participants
n=320 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=76 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=320 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=76 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=320 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=76 Participants
|
0 Participants
n=74 Participants
|
1 Participants
n=72 Participants
|
2 Participants
n=72 Participants
|
2 Participants
n=26 Participants
|
7 Participants
n=320 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=76 Participants
|
0 Participants
n=74 Participants
|
1 Participants
n=72 Participants
|
0 Participants
n=72 Participants
|
1 Participants
n=26 Participants
|
2 Participants
n=320 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=76 Participants
|
5 Participants
n=74 Participants
|
2 Participants
n=72 Participants
|
0 Participants
n=72 Participants
|
2 Participants
n=26 Participants
|
11 Participants
n=320 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=76 Participants
|
69 Participants
n=74 Participants
|
68 Participants
n=72 Participants
|
70 Participants
n=72 Participants
|
20 Participants
n=26 Participants
|
299 Participants
n=320 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=76 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=72 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=320 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=76 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=320 Participants
|
|
Region of Enrollment
United States
|
76 Participants
n=76 Participants
|
74 Participants
n=74 Participants
|
72 Participants
n=72 Participants
|
72 Participants
n=72 Participants
|
26 Participants
n=26 Participants
|
320 Participants
n=320 Participants
|
|
Height
|
166.8 cm
STANDARD_DEVIATION 9.95 • n=76 Participants • Data is reported for elderly participants only.
|
167.3 cm
STANDARD_DEVIATION 9.52 • n=74 Participants • Data is reported for elderly participants only.
|
168.0 cm
STANDARD_DEVIATION 9.17 • n=72 Participants • Data is reported for elderly participants only.
|
167.4 cm
STANDARD_DEVIATION 10.26 • n=72 Participants • Data is reported for elderly participants only.
|
169.4 cm
STANDARD_DEVIATION 11.42 • n=25 Participants • Data is reported for young adult participants only for whom data for height was available at Baseline.
|
169.4 cm
STANDARD_DEVIATION 11.42 • n=25 Participants • Data is reported for young adult participants only for whom data for height was available at Baseline.
|
|
Weight
|
75.56 kg
STANDARD_DEVIATION 14.376 • n=76 Participants • Data is reported for elderly participants only.
|
73.76 kg
STANDARD_DEVIATION 13.804 • n=74 Participants • Data is reported for elderly participants only.
|
77.26 kg
STANDARD_DEVIATION 14.404 • n=72 Participants • Data is reported for elderly participants only.
|
74.34 kg
STANDARD_DEVIATION 13.965 • n=72 Participants • Data is reported for elderly participants only.
|
78.22 kg
STANDARD_DEVIATION 15.357 • n=25 Participants • Data is reported for young adult participants only for whom data for weight was available at Baseline.
|
78.22 kg
STANDARD_DEVIATION 15.357 • n=25 Participants • Data is reported for young adult participants only for whom data for weight was available at Baseline.
|
|
Body Mass Index (BMI)
|
27.01 kg/m^2
STANDARD_DEVIATION 3.554 • n=76 Participants • Data is reported for elderly participants only.
|
26.28 kg/m^2
STANDARD_DEVIATION 3.958 • n=74 Participants • Data is reported for elderly participants only.
|
27.29 kg/m^2
STANDARD_DEVIATION 3.899 • n=72 Participants • Data is reported for elderly participants only.
|
26.46 kg/m^2
STANDARD_DEVIATION 3.909 • n=72 Participants • Data is reported for elderly participants only.
|
27.22 kg/m^2
STANDARD_DEVIATION 4.481 • n=25 Participants • Data is reported for young adult participants only for whom data for BMI was available at Baseline.
|
27.22 kg/m^2
STANDARD_DEVIATION 4.481 • n=25 Participants • Data is reported for young adult participants only for whom data for BMI was available at Baseline.
|
PRIMARY outcome
Timeframe: Day 57Population: Per Protocol Set (PPS) included all participants in the Full Analysis Set (FAS), who receive the planned vaccination \[both doses of vaccine, i.e. Norovirus (NoV) VLP vaccine or placebo\], and did not have major protocol violations. Overall number of participants analyzed is the number of participants with data available for analyses.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=65 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=62 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=71 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 and GII.4 Virus Like Particles (VLP) as Measured by Histoblood Group Antigen (HBGA) Blocking Assay on Day 57
|
41.5 percentage of participants
Interval 29.4 to 54.4
|
56.5 percentage of participants
Interval 43.3 to 69.0
|
63.6 percentage of participants
Interval 50.9 to 75.1
|
45.8 percentage of participants
Interval 25.6 to 67.2
|
42.3 percentage of participants
Interval 30.6 to 54.6
|
PRIMARY outcome
Timeframe: Within 7 days of first vaccination on Day 1Population: Safety Analysis Set (SAF) included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Number analyzed is the number of participants with evaluable data for the specific category.
Solicited local AEs at the injection site that occurred within 7 days after each vaccination were collected using a diary and included pain, erythema swelling and induration.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=74 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=72 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=25 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=76 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
Any Solicited Local AEs
|
26.0 percentage of participants
|
15.3 percentage of participants
|
34.7 percentage of participants
|
4.0 percentage of participants
|
6.6 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
Pain
|
23.3 percentage of participants
|
9.7 percentage of participants
|
34.7 percentage of participants
|
4.0 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
Erythema
|
2.7 percentage of participants
|
4.2 percentage of participants
|
1.4 percentage of participants
|
4.0 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
Swelling
|
2.7 percentage of participants
|
2.8 percentage of participants
|
1.4 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
Induration
|
1.4 percentage of participants
|
1.4 percentage of participants
|
1.4 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Within 7 days of second vaccination on Day 29Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Overall number of participants analyzed is the number of participants with data available for analyses.
Solicited local AEs at the injection site that occurred within 7 days after each vaccination were collected using a diary and included pain, erythema, swelling and induration.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=69 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=68 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=73 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
Any Solicited Local AEs
|
21.7 percentage of participants
|
38.2 percentage of participants
|
39.4 percentage of participants
|
41.7 percentage of participants
|
37.0 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
Pain
|
21.7 percentage of participants
|
38.2 percentage of participants
|
37.9 percentage of participants
|
41.7 percentage of participants
|
32.9 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
Erythema
|
0.0 percentage of participants
|
1.5 percentage of participants
|
3.0 percentage of participants
|
0.0 percentage of participants
|
2.7 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
Swelling
|
0.0 percentage of participants
|
1.5 percentage of participants
|
1.5 percentage of participants
|
0.0 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
Induration
|
0.0 percentage of participants
|
1.5 percentage of participants
|
1.5 percentage of participants
|
0.0 percentage of participants
|
1.4 percentage of participants
|
PRIMARY outcome
Timeframe: Within 7 days of first vaccination on Day 1Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Number analyzed is the number of participants with evaluable data for the specific category.
Solicited systemic AEs that occurred within 7 days after each vaccination were collected using a diary and included headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=74 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=72 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=25 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=76 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
Any solicited systemic AEs
|
34.2 percentage of participants
|
30.6 percentage of participants
|
44.4 percentage of participants
|
36.0 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
Headache
|
2.7 percentage of participants
|
11.1 percentage of participants
|
12.5 percentage of participants
|
20.0 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
Fatigue
|
24.7 percentage of participants
|
9.7 percentage of participants
|
27.8 percentage of participants
|
28.0 percentage of participants
|
18.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
Myalgia
|
13.7 percentage of participants
|
11.1 percentage of participants
|
20.8 percentage of participants
|
16.0 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
Arthralgia
|
8.2 percentage of participants
|
6.9 percentage of participants
|
6.9 percentage of participants
|
4.0 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
Vomiting
|
1.4 percentage of participants
|
0.0 percentage of participants
|
2.8 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
Diarrhea
|
6.8 percentage of participants
|
8.3 percentage of participants
|
18.1 percentage of participants
|
8.0 percentage of participants
|
5.3 percentage of participants
|
PRIMARY outcome
Timeframe: Within 7 days of second vaccination on Day 29Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Overall number of participants analyzed is the number of participants with data available for analyses.
Solicited systemic AEs that occurred within 7 days after each vaccination were collected using a diary and included headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=69 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=68 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=73 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
Fatigue
|
15.9 percentage of participants
|
13.2 percentage of participants
|
15.2 percentage of participants
|
8.3 percentage of participants
|
12.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
Myalgia
|
5.8 percentage of participants
|
7.4 percentage of participants
|
13.6 percentage of participants
|
4.2 percentage of participants
|
6.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
Arthralgia
|
7.2 percentage of participants
|
4.4 percentage of participants
|
6.1 percentage of participants
|
4.2 percentage of participants
|
4.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
Vomiting
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.5 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
Any solicited systemic AEs
|
20.3 percentage of participants
|
20.6 percentage of participants
|
28.8 percentage of participants
|
16.7 percentage of participants
|
19.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
Headache
|
5.8 percentage of participants
|
5.9 percentage of participants
|
6.1 percentage of participants
|
4.2 percentage of participants
|
8.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
Diarrhea
|
4.3 percentage of participants
|
2.9 percentage of participants
|
4.5 percentage of participants
|
0.0 percentage of participants
|
1.4 percentage of participants
|
PRIMARY outcome
Timeframe: Within 7 days of first vaccination on Day 1Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Overall number of participants analyzed is the number of participants with data available for analyses.
The body temperature measurement was performed using the thermometer for 7 days after each vaccination. The highest body temperature observed each day was recorded on the diary card. An elevated temperature is ≥ 38 °C or 100.4°F (considered as fever).
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=72 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=71 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=25 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=76 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Within 7 days of second vaccination on Day 29Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Overall number of participants analyzed is the number of participants with data available for analyses.
The body temperature measurement was performed using the thermometer for 7 days after each vaccination. The highest body temperature observed each day was recorded on the diary card. An elevated temperature is ≥ 38 °C or 100.4°F (considered as fever).
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=69 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=68 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=73 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.5 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Within 28 days of first vaccination on Day 1Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=74 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=72 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=25 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=76 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After First Vaccination on Day 1
|
28.4 percentage of participants
|
33.3 percentage of participants
|
26.4 percentage of participants
|
20.0 percentage of participants
|
32.9 percentage of participants
|
PRIMARY outcome
Timeframe: Within 28 days of second vaccination on Day 29Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Overall number of participants analyzed is number of participants with data available for analyses.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=69 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=68 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=73 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After Second Vaccination on Day 29
|
18.8 percentage of participants
|
25.0 percentage of participants
|
30.3 percentage of participants
|
8.3 percentage of participants
|
34.2 percentage of participants
|
PRIMARY outcome
Timeframe: From first vaccination up to Day 393Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
An SAE is any untoward medical occurrence 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 |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=74 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=72 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=25 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=76 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants With At Least One Serious Adverse Event (SAE)
|
12.2 percentage of participants
|
23.6 percentage of participants
|
12.5 percentage of participants
|
0.0 percentage of participants
|
9.2 percentage of participants
|
SECONDARY outcome
Timeframe: Days 8, 29, 36, 211 and 393Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=67 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=66 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
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 HBGA Blocking Assay
Day 29
|
40.9 percentage of participants
Interval 29.0 to 53.7
|
0.0 percentage of participants
Interval 0.0 to 5.4
|
54.5 percentage of participants
Interval 41.8 to 66.9
|
0.0 percentage of participants
Interval 0.0 to 14.2
|
0.0 percentage of participants
Interval 0.0 to 5.0
|
|
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 HBGA Blocking Assay
Day 8
|
33.8 percentage of participants
Interval 22.6 to 46.6
|
0.0 percentage of participants
Interval 0.0 to 5.4
|
55.4 percentage of participants
Interval 42.5 to 67.7
|
0.0 percentage of participants
Interval 0.0 to 14.8
|
0.0 percentage of participants
Interval 0.0 to 5.0
|
|
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 HBGA Blocking Assay
Day 36
|
45.5 percentage of participants
Interval 33.1 to 58.2
|
34.4 percentage of participants
Interval 22.9 to 47.3
|
63.6 percentage of participants
Interval 50.9 to 75.1
|
43.5 percentage of participants
Interval 23.2 to 65.5
|
26.4 percentage of participants
Interval 16.7 to 38.1
|
|
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 HBGA Blocking Assay
Day 211
|
18.2 percentage of participants
Interval 9.8 to 29.6
|
28.1 percentage of participants
Interval 17.6 to 40.8
|
30.3 percentage of participants
Interval 19.6 to 42.9
|
8.7 percentage of participants
Interval 1.1 to 28.0
|
15.5 percentage of participants
Interval 8.0 to 26.0
|
|
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 HBGA Blocking Assay
Day 393
|
10.9 percentage of participants
Interval 4.5 to 21.2
|
19.0 percentage of participants
Interval 10.2 to 30.9
|
16.9 percentage of participants
Interval 8.8 to 28.3
|
13.0 percentage of participants
Interval 2.8 to 33.6
|
12.9 percentage of participants
Interval 6.1 to 23.0
|
SECONDARY outcome
Timeframe: Days 8, 29, 36, 57, 211 and 393Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=67 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=66 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA)
Day 8
|
63.1 percentage of participants
Interval 50.2 to 74.7
|
0.0 percentage of participants
Interval 0.0 to 5.4
|
76.9 percentage of participants
Interval 64.8 to 86.5
|
0.0 percentage of participants
Interval 0.0 to 14.8
|
1.4 percentage of participants
Interval 0.0 to 7.5
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA)
Day 29
|
72.7 percentage of participants
Interval 60.4 to 83.0
|
0.0 percentage of participants
Interval 0.0 to 5.4
|
77.3 percentage of participants
Interval 65.3 to 86.7
|
0.0 percentage of participants
Interval 0.0 to 14.2
|
0.0 percentage of participants
Interval 0.0 to 5.0
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA)
Day 36
|
74.2 percentage of participants
Interval 62.0 to 84.2
|
65.6 percentage of participants
Interval 52.7 to 77.1
|
89.4 percentage of participants
Interval 79.4 to 95.6
|
60.9 percentage of participants
Interval 38.5 to 80.3
|
55.6 percentage of participants
Interval 43.4 to 67.3
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA)
Day 57
|
80.0 percentage of participants
Interval 68.2 to 88.9
|
74.2 percentage of participants
Interval 61.5 to 84.5
|
89.4 percentage of participants
Interval 79.4 to 95.6
|
62.5 percentage of participants
Interval 40.6 to 81.2
|
64.8 percentage of participants
Interval 52.5 to 75.8
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA)
Day 211
|
57.6 percentage of participants
Interval 44.8 to 69.7
|
54.7 percentage of participants
Interval 41.7 to 67.2
|
57.6 percentage of participants
Interval 44.8 to 69.7
|
26.1 percentage of participants
Interval 10.2 to 48.4
|
33.8 percentage of participants
Interval 23.0 to 46.0
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA)
Day 393
|
50.0 percentage of participants
Interval 37.2 to 62.8
|
41.3 percentage of participants
Interval 29.0 to 54.4
|
47.7 percentage of participants
Interval 35.1 to 60.5
|
30.4 percentage of participants
Interval 13.2 to 52.9
|
25.7 percentage of participants
Interval 16.0 to 37.6
|
SECONDARY outcome
Timeframe: Days 8, 29, 36, 57, 211 and 393Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=67 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=66 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 8
|
54.5 percentage of participants
Interval 41.8 to 66.9
|
1.5 percentage of participants
Interval 0.0 to 8.2
|
69.2 percentage of participants
Interval 56.6 to 80.1
|
0.0 percentage of participants
Interval 0.0 to 14.8
|
0.0 percentage of participants
Interval 0.0 to 5.0
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 29
|
59.7 percentage of participants
Interval 47.0 to 71.5
|
0.0 percentage of participants
Interval 0.0 to 5.4
|
71.2 percentage of participants
Interval 58.7 to 81.7
|
0.0 percentage of participants
Interval 0.0 to 14.2
|
1.4 percentage of participants
Interval 0.0 to 7.5
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 36
|
62.7 percentage of participants
Interval 50.0 to 74.2
|
53.1 percentage of participants
Interval 40.2 to 65.7
|
71.2 percentage of participants
Interval 58.7 to 81.7
|
78.3 percentage of participants
Interval 56.3 to 92.5
|
56.9 percentage of participants
Interval 44.7 to 68.6
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 57
|
57.6 percentage of participants
Interval 44.8 to 69.7
|
74.2 percentage of participants
Interval 61.5 to 84.5
|
71.2 percentage of participants
Interval 58.7 to 81.7
|
66.7 percentage of participants
Interval 44.7 to 84.4
|
67.6 percentage of participants
Interval 55.5 to 78.2
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 211
|
34.8 percentage of participants
Interval 23.5 to 47.6
|
45.3 percentage of participants
Interval 32.8 to 58.3
|
45.5 percentage of participants
Interval 33.1 to 58.2
|
47.8 percentage of participants
Interval 26.8 to 69.4
|
39.4 percentage of participants
Interval 28.0 to 51.7
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 393
|
30.8 percentage of participants
Interval 19.9 to 43.4
|
33.3 percentage of participants
Interval 22.0 to 46.3
|
36.9 percentage of participants
Interval 25.3 to 49.8
|
39.1 percentage of participants
Interval 19.7 to 61.5
|
34.3 percentage of participants
Interval 23.3 to 46.6
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 8, 29, 36, 57, 211 and 393Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
GMT GI.1 VLP antibody titers measured by HBGA blocking assay are reported.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=67 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=66 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA)
Baseline (Day 1)
|
29.0 titer
Interval 22.3 to 37.7
|
26.7 titer
Interval 20.9 to 34.2
|
23.9 titer
Interval 19.8 to 28.8
|
22.0 titer
Interval 15.4 to 31.6
|
26.5 titer
Interval 20.9 to 33.6
|
|
Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA)
Day 8
|
282.4 titer
Interval 193.2 to 412.6
|
26.5 titer
Interval 20.9 to 33.6
|
332.3 titer
Interval 209.9 to 526.1
|
21.7 titer
Interval 15.3 to 30.8
|
26.6 titer
Interval 20.9 to 33.9
|
|
Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA)
Day 29
|
373.6 titer
Interval 266.9 to 523.0
|
27.3 titer
Interval 21.4 to 34.8
|
285.5 titer
Interval 192.9 to 422.6
|
21.7 titer
Interval 15.3 to 30.9
|
26.2 titer
Interval 20.8 to 33.0
|
|
Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA)
Day 36
|
361.1 titer
Interval 266.5 to 489.2
|
280.1 titer
Interval 184.3 to 425.7
|
338.9 titer
Interval 247.7 to 463.7
|
150.8 titer
Interval 75.0 to 303.4
|
194.2 titer
Interval 130.3 to 289.4
|
|
Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA)
Day 57
|
353.6 titer
Interval 268.6 to 465.6
|
262.2 titer
Interval 180.5 to 381.0
|
317.1 titer
Interval 238.3 to 421.9
|
117.7 titer
Interval 63.1 to 219.5
|
177.0 titer
Interval 124.4 to 251.9
|
|
Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA)
Day 211
|
160.5 titer
Interval 116.5 to 221.1
|
128.3 titer
Interval 92.7 to 177.7
|
126.7 titer
Interval 92.7 to 173.3
|
54.1 titer
Interval 30.1 to 97.0
|
81.8 titer
Interval 60.4 to 110.6
|
|
Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA)
Day 393
|
112.2 titer
Interval 80.4 to 156.5
|
85.7 titer
Interval 61.8 to 118.9
|
84.6 titer
Interval 60.3 to 118.5
|
41.0 titer
Interval 23.3 to 72.2
|
60.2 titer
Interval 43.9 to 82.5
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 8, 29, 36, 57, 211 and 393Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
GMT of anti-norovirus GII.4 VLP antibody titers measured by HBGA blocking assay are reported.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=67 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=66 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 29
|
787.7 titer
Interval 524.9 to 1182.1
|
82.8 titer
Interval 57.5 to 119.3
|
876.1 titer
Interval 648.5 to 1183.6
|
67.2 titer
Interval 38.0 to 118.8
|
58.6 titer
Interval 42.0 to 81.6
|
|
GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 36
|
757.1 titer
Interval 526.7 to 1088.4
|
733.8 titer
Interval 460.0 to 1170.7
|
799.4 titer
Interval 604.1 to 1057.9
|
1234.5 titer
Interval 627.3 to 2429.4
|
556.5 titer
Interval 354.6 to 873.2
|
|
GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 57
|
600.6 titer
Interval 417.3 to 864.5
|
790.8 titer
Interval 543.4 to 1151.0
|
613.6 titer
Interval 475.5 to 791.8
|
742.0 titer
Interval 406.9 to 1352.9
|
528.0 titer
Interval 366.2 to 761.2
|
|
GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 211
|
298.9 titer
Interval 204.6 to 436.6
|
318.6 titer
Interval 228.6 to 444.1
|
315.9 titer
Interval 233.7 to 427.1
|
280.3 titer
Interval 163.4 to 480.8
|
222.0 titer
Interval 158.2 to 311.6
|
|
GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 393
|
249.8 titer
Interval 164.4 to 379.8
|
265.9 titer
Interval 184.4 to 383.6
|
278.9 titer
Interval 204.9 to 379.7
|
223.4 titer
Interval 114.5 to 436.0
|
188.9 titer
Interval 129.7 to 275.1
|
|
GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Baseline (Day 1)
|
100.3 titer
Interval 70.8 to 142.2
|
99.5 titer
Interval 67.4 to 146.8
|
86.1 titer
Interval 60.7 to 122.2
|
78.7 titer
Interval 43.7 to 141.4
|
66.5 titer
Interval 48.4 to 91.4
|
|
GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 8
|
694.9 titer
Interval 462.6 to 1043.9
|
94.1 titer
Interval 65.2 to 135.8
|
994.9 titer
Interval 724.8 to 1365.8
|
75.2 titer
Interval 41.3 to 137.0
|
60.7 titer
Interval 43.8 to 84.2
|
SECONDARY outcome
Timeframe: Days 8, 29, 36, 57, 211 and 393Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
GMFR of anti-norovirus GI.1 VLP antibody titers measured by HBGA blocking assay are reported. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=67 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=66 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA)
Day 8
|
10.1 ratio
Interval 6.6 to 15.6
|
1.0 ratio
Interval 0.9 to 1.0
|
14.1 ratio
Interval 9.2 to 21.6
|
1.0 ratio
Interval 0.9 to 1.0
|
1.0 ratio
Interval 0.9 to 1.1
|
|
Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA)
Day 29
|
13.0 ratio
Interval 9.1 to 18.6
|
1.0 ratio
Interval 1.0 to 1.1
|
12.0 ratio
Interval 8.5 to 16.8
|
1.0 ratio
Interval 0.9 to 1.1
|
1.0 ratio
Interval 1.0 to 1.0
|
|
Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA)
Day 36
|
12.6 ratio
Interval 9.1 to 17.4
|
10.6 ratio
Interval 7.0 to 15.9
|
14.2 ratio
Interval 10.7 to 18.8
|
7.5 ratio
Interval 3.9 to 14.6
|
7.3 ratio
Interval 4.9 to 10.9
|
|
Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA)
Day 57
|
12.1 ratio
Interval 9.1 to 16.2
|
10.0 ratio
Interval 7.1 to 14.0
|
13.3 ratio
Interval 10.3 to 17.1
|
5.3 ratio
Interval 3.0 to 9.6
|
6.6 ratio
Interval 4.8 to 9.1
|
|
Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA)
Day 211
|
5.5 ratio
Interval 4.2 to 7.3
|
4.8 ratio
Interval 3.7 to 6.3
|
5.3 ratio
Interval 4.1 to 6.8
|
2.4 ratio
Interval 1.4 to 4.0
|
3.2 ratio
Interval 2.6 to 4.0
|
|
Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA)
Day 393
|
3.9 ratio
Interval 3.0 to 5.2
|
3.2 ratio
Interval 2.5 to 4.1
|
3.5 ratio
Interval 2.7 to 4.6
|
1.8 ratio
Interval 1.1 to 2.9
|
2.4 ratio
Interval 1.9 to 3.0
|
SECONDARY outcome
Timeframe: Days 8, 29, 36, 57, 211 and 393Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
GMFR of anti-norovirus GII.4 VLP antibody titers measured by HBGA blocking assay are reported. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=67 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=66 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 8
|
6.9 ratio
Interval 4.5 to 10.5
|
0.9 ratio
Interval 0.8 to 1.1
|
11.6 ratio
Interval 7.7 to 17.5
|
0.9 ratio
Interval 0.8 to 1.0
|
0.9 ratio
Interval 0.8 to 1.0
|
|
GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 29
|
7.9 ratio
Interval 5.6 to 11.0
|
0.8 ratio
Interval 0.7 to 1.0
|
10.2 ratio
Interval 7.2 to 14.5
|
0.9 ratio
Interval 0.8 to 1.0
|
0.9 ratio
Interval 0.8 to 1.0
|
|
GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 36
|
7.5 ratio
Interval 5.5 to 10.4
|
7.3 ratio
Interval 4.8 to 11.2
|
9.3 ratio
Interval 6.6 to 13.0
|
15.1 ratio
Interval 7.1 to 32.2
|
8.4 ratio
Interval 5.4 to 13.0
|
|
GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 57
|
5.8 ratio
Interval 4.3 to 7.8
|
8.4 ratio
Interval 6.1 to 11.7
|
7.1 ratio
Interval 5.3 to 9.6
|
9.4 ratio
Interval 4.8 to 18.4
|
8.1 ratio
Interval 5.8 to 11.4
|
|
GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 211
|
3.0 ratio
Interval 2.2 to 4.1
|
3.4 ratio
Interval 2.5 to 4.5
|
3.7 ratio
Interval 2.8 to 4.8
|
3.8 ratio
Interval 2.2 to 6.5
|
3.4 ratio
Interval 2.6 to 4.5
|
|
GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Day 393
|
2.6 ratio
Interval 2.0 to 3.5
|
2.7 ratio
Interval 2.1 to 3.5
|
3.2 ratio
Interval 2.4 to 4.1
|
3.0 ratio
Interval 1.7 to 5.4
|
3.0 ratio
Interval 2.3 to 3.8
|
SECONDARY outcome
Timeframe: Days 8, 29, 36, 57, 211 and 393Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data 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 measured by Pan-Ig ELISA are reported.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=67 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=66 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
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 Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA)
Day 8
|
31.8 percentage of participants
Interval 20.9 to 44.4
|
0.0 percentage of participants
Interval 0.0 to 5.4
|
52.3 percentage of participants
Interval 39.5 to 64.9
|
0.0 percentage of participants
Interval 0.0 to 14.8
|
0.0 percentage of participants
Interval 0.0 to 5.0
|
|
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 Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA)
Day 29
|
47.8 percentage of participants
Interval 35.4 to 60.3
|
0.0 percentage of participants
Interval 0.0 to 5.4
|
62.1 percentage of participants
Interval 49.3 to 73.8
|
0.0 percentage of participants
Interval 0.0 to 14.2
|
1.4 percentage of participants
Interval 0.0 to 7.5
|
|
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 Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA)
Day 36
|
49.3 percentage of participants
Interval 36.8 to 61.8
|
39.1 percentage of participants
Interval 27.1 to 52.1
|
63.6 percentage of participants
Interval 50.9 to 75.1
|
69.6 percentage of participants
Interval 47.1 to 86.8
|
37.5 percentage of participants
Interval 26.4 to 49.7
|
|
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 Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA)
Day 57
|
43.9 percentage of participants
Interval 31.7 to 56.7
|
58.1 percentage of participants
Interval 44.8 to 70.5
|
62.1 percentage of participants
Interval 49.3 to 73.8
|
62.5 percentage of participants
Interval 40.6 to 81.2
|
52.1 percentage of participants
Interval 39.9 to 64.1
|
|
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 Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA)
Day 211
|
37.9 percentage of participants
Interval 26.2 to 50.7
|
40.6 percentage of participants
Interval 28.5 to 53.6
|
42.4 percentage of participants
Interval 30.3 to 55.2
|
47.8 percentage of participants
Interval 26.8 to 69.4
|
40.8 percentage of participants
Interval 29.3 to 53.2
|
|
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 Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA)
Day 393
|
15.4 percentage of participants
Interval 7.6 to 26.5
|
25.4 percentage of participants
Interval 15.3 to 37.9
|
23.1 percentage of participants
Interval 13.5 to 35.2
|
30.4 percentage of participants
Interval 13.2 to 52.9
|
24.3 percentage of participants
Interval 14.8 to 36.0
|
SECONDARY outcome
Timeframe: Days 8, 29, 36, 57, 211 and 393Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
Percentage of participants with a 4-Fold rise or greater in serum anti-norovirus GI.1 VLP antibody titers measured by Pan-Ig ELISA are reported.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=67 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=66 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 8
|
56.1 percentage of participants
Interval 43.3 to 68.3
|
0.0 percentage of participants
Interval 0.0 to 5.4
|
69.2 percentage of participants
Interval 56.6 to 80.1
|
0.0 percentage of participants
Interval 0.0 to 14.8
|
0.0 percentage of participants
Interval 0.0 to 5.0
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 29
|
67.2 percentage of participants
Interval 54.6 to 78.2
|
0.0 percentage of participants
Interval 0.0 to 5.4
|
80.3 percentage of participants
Interval 68.7 to 89.1
|
8.3 percentage of participants
Interval 1.0 to 27.0
|
1.4 percentage of participants
Interval 0.0 to 7.5
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 36
|
67.2 percentage of participants
Interval 54.6 to 78.2
|
68.8 percentage of participants
Interval 55.9 to 79.8
|
83.3 percentage of participants
Interval 72.1 to 91.4
|
91.3 percentage of participants
Interval 72.0 to 98.9
|
59.7 percentage of participants
Interval 47.5 to 71.1
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 57
|
65.2 percentage of participants
Interval 52.4 to 76.5
|
83.9 percentage of participants
Interval 72.3 to 92.0
|
84.8 percentage of participants
Interval 73.9 to 92.5
|
87.5 percentage of participants
Interval 67.6 to 97.3
|
73.2 percentage of participants
Interval 61.4 to 83.1
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 211
|
63.6 percentage of participants
Interval 50.9 to 75.1
|
70.3 percentage of participants
Interval 57.6 to 81.1
|
72.7 percentage of participants
Interval 60.4 to 83.0
|
73.9 percentage of participants
Interval 51.6 to 89.8
|
62.0 percentage of participants
Interval 49.7 to 73.2
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 393
|
41.5 percentage of participants
Interval 29.4 to 54.4
|
52.4 percentage of participants
Interval 39.4 to 65.1
|
60.0 percentage of participants
Interval 47.1 to 72.0
|
60.9 percentage of participants
Interval 38.5 to 80.3
|
48.6 percentage of participants
Interval 36.4 to 60.8
|
SECONDARY outcome
Timeframe: Days 8, 29, 36, 57, 211 and 393Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
Percentage of participants with a 4-fold rise or greater in serum anti-norovirus GII.4 VLP antibody titers measured by Pan-Ig ELISA are reported.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=67 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=66 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 8
|
50.0 percentage of participants
Interval 29.1 to 70.9
|
0.0 percentage of participants
Interval 0.0 to 14.8
|
62.5 percentage of participants
Interval 40.6 to 81.2
|
0.0 percentage of participants
Interval 0.0 to 14.8
|
0.0 percentage of participants
Interval 0.0 to 14.2
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 29
|
70.8 percentage of participants
Interval 48.9 to 87.4
|
0.0 percentage of participants
Interval 0.0 to 14.8
|
70.8 percentage of participants
Interval 48.9 to 87.4
|
0.0 percentage of participants
Interval 0.0 to 14.2
|
0.0 percentage of participants
Interval 0.0 to 14.2
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 36
|
68.7 percentage of participants
Interval 56.2 to 79.4
|
48.4 percentage of participants
Interval 35.8 to 61.3
|
71.2 percentage of participants
Interval 58.7 to 81.7
|
73.9 percentage of participants
Interval 51.6 to 89.8
|
52.8 percentage of participants
Interval 40.7 to 64.7
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 57
|
63.6 percentage of participants
Interval 50.9 to 75.1
|
67.7 percentage of participants
Interval 54.7 to 79.1
|
68.2 percentage of participants
Interval 55.6 to 79.1
|
66.7 percentage of participants
Interval 44.7 to 84.4
|
70.4 percentage of participants
Interval 58.4 to 80.7
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 211
|
53.0 percentage of participants
Interval 40.3 to 65.4
|
50.0 percentage of participants
Interval 37.2 to 62.8
|
53.0 percentage of participants
Interval 40.3 to 65.4
|
52.2 percentage of participants
Interval 30.6 to 73.2
|
60.6 percentage of participants
Interval 48.3 to 72.0
|
|
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 393
|
32.3 percentage of participants
Interval 21.2 to 45.1
|
34.9 percentage of participants
Interval 23.3 to 48.0
|
36.9 percentage of participants
Interval 25.3 to 49.8
|
34.8 percentage of participants
Interval 16.4 to 57.3
|
34.3 percentage of participants
Interval 23.3 to 46.6
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 8, 29, 36, 57, 211 and 393Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
GMT of anti-norovirus GI.1 VLP antibody titers measured by Pan-Ig ELISA are reported.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=67 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=66 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Baseline (Day 1)
|
906.1 titer
Interval 622.4 to 1319.3
|
838.5 titer
Interval 605.8 to 1160.4
|
619.7 titer
Interval 459.7 to 835.2
|
460.3 titer
Interval 204.8 to 1034.6
|
661.8 titer
Interval 508.5 to 861.2
|
|
GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 8
|
4534.9 titer
Interval 3303.2 to 6225.8
|
829.4 titer
Interval 603.0 to 1140.8
|
6382.8 titer
Interval 4698.1 to 8671.7
|
455.2 titer
Interval 192.4 to 1076.7
|
678.0 titer
Interval 519.7 to 884.5
|
|
GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 29
|
7701.1 titer
Interval 6141.9 to 9656.0
|
791.9 titer
Interval 585.7 to 1070.9
|
8951.5 titer
Interval 7127.3 to 11242.6
|
574.0 titer
Interval 273.1 to 1206.2
|
668.2 titer
Interval 520.4 to 857.9
|
|
GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 36
|
7663.6 titer
Interval 6165.5 to 9525.6
|
6411.8 titer
Interval 4795.4 to 8573.1
|
9161.1 titer
Interval 7501.2 to 11188.4
|
7603.5 titer
Interval 4590.2 to 12595.1
|
4158.6 titer
Interval 3095.1 to 5587.6
|
|
GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 57
|
7235.1 titer
Interval 5945.9 to 8804.0
|
8838.3 titer
Interval 6928.3 to 11275.0
|
8182.2 titer
Interval 6751.1 to 9916.8
|
8165.5 titer
Interval 5659.8 to 11780.6
|
6183.5 titer
Interval 4929.9 to 7755.8
|
|
GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 211
|
5161.2 titer
Interval 4206.5 to 6332.6
|
5406.6 titer
Interval 4433.7 to 6593.0
|
4882.3 titer
Interval 4069.9 to 5856.9
|
3523.2 titer
Interval 2277.6 to 5449.9
|
3945.2 titer
Interval 3233.5 to 4813.6
|
|
GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 393
|
3672.1 titer
Interval 2835.7 to 4755.2
|
3862.9 titer
Interval 3060.2 to 4876.3
|
3370.0 titer
Interval 2799.0 to 4057.5
|
2252.6 titer
Interval 1365.3 to 3716.5
|
2903.4 titer
Interval 2307.1 to 3653.9
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 8, 29, 36, 57, 211 and 393Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
GMT of anti-norovirus GII.4 VLP antibody titers measured by Pan-Ig ELISA are reported.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=67 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=66 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Baseline (Day 1)
|
1054.9 titer
Interval 707.8 to 1572.4
|
1066.3 titer
Interval 719.7 to 1580.0
|
897.4 titer
Interval 612.3 to 1315.3
|
1023.2 titer
Interval 543.8 to 1925.3
|
761.9 titer
Interval 547.9 to 1059.7
|
|
GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 8
|
4725.5 titer
Interval 3479.7 to 6417.3
|
1078.9 titer
Interval 726.6 to 1602.0
|
5691.9 titer
Interval 4107.9 to 7886.7
|
1054.6 titer
Interval 550.6 to 2020.2
|
766.6 titer
Interval 553.1 to 1062.6
|
|
GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 29
|
8105.1 titer
Interval 6053.8 to 10851.6
|
1017.7 titer
Interval 690.1 to 1500.8
|
8314.1 titer
Interval 6388.3 to 10820.3
|
1022.4 titer
Interval 574.4 to 1819.7
|
766.8 titer
Interval 553.7 to 1062.0
|
|
GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 36
|
7911.9 titer
Interval 6059.9 to 10329.8
|
5411.9 titer
Interval 3777.0 to 7754.5
|
8025.5 titer
Interval 6339.1 to 10160.5
|
10084.9 titer
Interval 7037.2 to 14452.5
|
4587.6 titer
Interval 3402.2 to 6186.0
|
|
GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 57
|
7489.2 titer
Interval 5788.1 to 9690.4
|
7877.2 titer
Interval 5878.8 to 10554.9
|
7028.4 titer
Interval 5611.6 to 8803.0
|
9507.3 titer
Interval 7110.9 to 12711.2
|
6564.1 titer
Interval 5151.3 to 8364.5
|
|
GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 211
|
4915.8 titer
Interval 3676.9 to 6572.2
|
4657.8 titer
Interval 3510.6 to 6179.8
|
4456.2 titer
Interval 3493.1 to 5684.9
|
4531.5 titer
Interval 3194.5 to 6428.0
|
3702.0 titer
Interval 2913.0 to 4704.7
|
|
GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 393
|
3151.5 titer
Interval 2319.8 to 4281.5
|
2807.4 titer
Interval 2081.9 to 3785.8
|
2853.9 titer
Interval 2225.5 to 3659.7
|
2969.5 titer
Interval 1818.4 to 4849.5
|
2216.7 titer
Interval 1708.9 to 2875.3
|
SECONDARY outcome
Timeframe: Days 8, 29, 36, 57, 211 and 393Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
GMFR of anti-norovirus GI.1 VLP antibody titers measured by Pan-Ig ELISA are reported. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=67 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=66 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 8
|
5.1 ratio
Interval 3.7 to 7.2
|
1.0 ratio
Interval 0.9 to 1.0
|
10.3 ratio
Interval 7.2 to 14.7
|
1.0 ratio
Interval 0.9 to 1.1
|
1.0 ratio
Interval 1.0 to 1.1
|
|
GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 29
|
8.5 ratio
Interval 6.2 to 11.7
|
0.9 ratio
Interval 0.9 to 1.0
|
14.4 ratio
Interval 10.7 to 19.5
|
1.2 ratio
Interval 0.9 to 1.8
|
1.0 ratio
Interval 0.9 to 1.1
|
|
GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 36
|
8.5 ratio
Interval 6.1 to 11.7
|
7.6 ratio
Interval 5.5 to 10.6
|
14.8 ratio
Interval 10.9 to 20.0
|
17.3 ratio
Interval 8.4 to 35.9
|
6.3 ratio
Interval 4.5 to 8.8
|
|
GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 57
|
7.9 ratio
Interval 5.8 to 10.8
|
11.4 ratio
Interval 8.3 to 15.6
|
13.2 ratio
Interval 9.9 to 17.7
|
17.7 ratio
Interval 8.8 to 35.8
|
9.0 ratio
Interval 6.8 to 11.9
|
|
GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 211
|
5.8 ratio
Interval 4.3 to 7.7
|
6.4 ratio
Interval 4.9 to 8.5
|
7.9 ratio
Interval 6.2 to 10.0
|
8.0 ratio
Interval 4.1 to 15.4
|
6.0 ratio
Interval 4.8 to 7.5
|
|
GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Day 393
|
4.0 ratio
Interval 3.1 to 5.3
|
4.6 ratio
Interval 3.6 to 5.9
|
5.2 ratio
Interval 4.2 to 6.5
|
5.1 ratio
Interval 2.6 to 10.1
|
4.4 ratio
Interval 3.6 to 5.5
|
SECONDARY outcome
Timeframe: Days 8, 29, 36, 57, 211 and 393Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
GMFR of anti-norovirus GII.4 VLP antibody titers measured by Pan-Ig ELISA are reported. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=67 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=66 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=66 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=24 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 8
|
4.5 ratio
Interval 3.2 to 6.2
|
1.0 ratio
Interval 1.0 to 1.1
|
6.3 ratio
Interval 4.5 to 9.0
|
1.0 ratio
Interval 0.9 to 1.0
|
1.0 ratio
Interval 1.0 to 1.1
|
|
GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 29
|
7.7 ratio
Interval 5.7 to 10.4
|
1.0 ratio
Interval 0.9 to 1.0
|
9.3 ratio
Interval 6.7 to 12.8
|
1.0 ratio
Interval 0.9 to 1.1
|
1.0 ratio
Interval 0.9 to 1.1
|
|
GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 36
|
7.5 ratio
Interval 5.6 to 10.0
|
5.0 ratio
Interval 3.6 to 6.9
|
8.9 ratio
Interval 6.4 to 12.4
|
9.6 ratio
Interval 5.1 to 18.1
|
6.0 ratio
Interval 4.3 to 8.4
|
|
GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 57
|
6.9 ratio
Interval 5.2 to 9.2
|
8.3 ratio
Interval 6.2 to 11.0
|
7.8 ratio
Interval 5.8 to 10.6
|
9.3 ratio
Interval 5.1 to 16.8
|
8.7 ratio
Interval 6.4 to 11.7
|
|
GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 211
|
4.6 ratio
Interval 3.6 to 5.9
|
4.5 ratio
Interval 3.5 to 5.7
|
5.0 ratio
Interval 3.8 to 6.4
|
4.7 ratio
Interval 3.0 to 7.5
|
4.9 ratio
Interval 3.8 to 6.3
|
|
GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Day 393
|
3.1 ratio
Interval 2.4 to 3.9
|
2.6 ratio
Interval 2.1 to 3.3
|
3.0 ratio
Interval 2.4 to 3.8
|
3.1 ratio
Interval 1.9 to 5.0
|
3.1 ratio
Interval 2.4 to 3.8
|
SECONDARY outcome
Timeframe: From first vaccination up to Day 393Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESI included protocol specified Cardiac Disorders, Gastrointestinal Disorders, Immune System Disorders, Infections and Infestations, Musculoskeletal and Connective Tissue Diseases, Neuroinflammatory Disorders, Renal and Urinary Disorders, Skin Disorders, Thyroid Disorders, Vascular Disorders and Other Disorders.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=74 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=72 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=25 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=76 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants With At Least One Adverse Event of Special Interest (AESI)
|
2.7 percentage of participants
|
2.8 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.3 percentage of participants
|
SECONDARY outcome
Timeframe: From first vaccination up to Day 393Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
Withdrawal due to an AE will occur if the participant experiences an AE that requires early termination of treatment, because continued participation imposes an unacceptable risk to the participant's health or the participant is unwilling to continue because of the AE.
Outcome measures
| Measure |
Arm 2: NoV Vaccine Formulation A_2-Dose
n=74 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=72 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=72 Participants
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=25 Participants
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
Arm 1: NoV Vaccine Formulation A_1-Dose
n=76 Participants
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Percentage of Participants With At Least One Adverse Event (AE) Leading to Participant's Withdrawal From the Study
|
1.4 percentage of participants
|
0.0 percentage of participants
|
1.4 percentage of participants
|
0.0 percentage of participants
|
1.3 percentage of participants
|
Adverse Events
Arm 1: NoV Vaccine Formulation A_1-Dose
Serious events: 7 serious events
Other events: 28 other events
Deaths: 1 deaths
Arm 2: NoV Vaccine Formulation A_2-Dose
Serious events: 9 serious events
Other events: 25 other events
Deaths: 1 deaths
Arm 3: NoV Vaccine Formulation B_1-Dose
Serious events: 17 serious events
Other events: 23 other events
Deaths: 0 deaths
Arm 4: NoV Vaccine Formulation B_2-Dose
Serious events: 9 serious events
Other events: 21 other events
Deaths: 1 deaths
Arm 5: NoV Vaccine Formulation A_1-Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: NoV Vaccine Formulation A_1-Dose
n=76 participants at risk
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
Arm 2: NoV Vaccine Formulation A_2-Dose
n=74 participants at risk
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=72 participants at risk
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=72 participants at risk
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=25 participants at risk
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.8%
2/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Cardiac disorders
Aortic valve stenosis
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Cardiac disorders
Atrioventricular block complete
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Cardiac disorders
Tachycardia
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Ear and labyrinth disorders
Vertigo positional
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
General disorders
Non-cardiac chest pain
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
General disorders
Complication associated with device
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Infections and infestations
Sepsis
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Infections and infestations
Splenic abscess
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Infections and infestations
Streptococcal endocarditis
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.8%
2/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Nervous system disorders
Seizure
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
Other adverse events
| Measure |
Arm 1: NoV Vaccine Formulation A_1-Dose
n=76 participants at risk
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
|
Arm 2: NoV Vaccine Formulation A_2-Dose
n=74 participants at risk
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
|
Arm 3: NoV Vaccine Formulation B_1-Dose
n=72 participants at risk
Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
|
Arm 4: NoV Vaccine Formulation B_2-Dose
n=72 participants at risk
Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
|
Arm 5: NoV Vaccine Formulation A_1-Dose
n=25 participants at risk
Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
|
|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
10.5%
8/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
10.8%
8/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
6.9%
5/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
4.2%
3/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
4.0%
1/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.6%
2/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
5.4%
4/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
8.0%
2/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.8%
2/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.8%
2/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.8%
2/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Infections and infestations
Otitis media
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.8%
2/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
4.0%
1/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
General disorders
Injection site bruising
|
5.3%
4/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
5.6%
4/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.8%
2/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
General disorders
Fatigue
|
3.9%
3/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
4.1%
3/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
4.2%
3/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
8.0%
2/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
2/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.8%
2/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
2/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.8%
2/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.8%
2/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
2/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
4.2%
3/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.8%
2/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
2/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
4.0%
1/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
4/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
4.1%
3/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.8%
2/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Injury, poisoning and procedural complications
Laceration
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.7%
2/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.7%
2/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.8%
2/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.6%
2/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
4.0%
1/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
4.0%
1/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Nervous system disorders
Headache
|
2.6%
2/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.7%
2/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
4.2%
3/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
4.0%
1/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Nervous system disorders
Dizziness
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
4.2%
3/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.8%
2/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
4.0%
1/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
4.0%
1/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.3%
1/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.8%
2/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
2.7%
2/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
|
Vascular disorders
Hypertension
|
2.6%
2/76 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/74 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
1.4%
1/72 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
0.00%
0/25 • All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
|
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