Trial Outcomes & Findings for Safety and Immunogenicity of Norovirus Bivalent Virus-Like Particle Vaccine in Healthy Adults (NCT NCT02142504)
NCT ID: NCT02142504
Last Updated: 2017-08-21
Results Overview
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after the primary injection.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
454 participants
Primary outcome timeframe
Days 1 through 7
Results posted on
2017-08-21
Participant Flow
Participants took part in the study at 10 investigative sites in the United States from 28 April 2014 to 14 January 2016.
Healthy volunteers were enrolled equally in 1 of 3 norovirus bivalent virus like particle (VLP) vaccine unique formulation treatment groups to receive: 2 formulation arms received 2 doses and 1 formulation arm received 1 dose.
Participant milestones
| Measure |
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
|---|---|---|---|
|
Overall Study
STARTED
|
154
|
153
|
147
|
|
Overall Study
Randomized and Received Treatment
|
154
|
153
|
145
|
|
Overall Study
Received Booster (Second Vaccination)
|
116
|
126
|
109
|
|
Overall Study
COMPLETED
|
111
|
122
|
105
|
|
Overall Study
NOT COMPLETED
|
43
|
31
|
42
|
Reasons for withdrawal
| Measure |
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
2
|
1
|
|
Overall Study
Adverse Event
|
4
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
17
|
12
|
19
|
|
Overall Study
Withdrawal by Subject
|
11
|
7
|
9
|
|
Overall Study
Pregnancy
|
2
|
4
|
4
|
|
Overall Study
Physician Decision
|
3
|
0
|
1
|
|
Overall Study
Reason Not Specified
|
4
|
4
|
5
|
Baseline Characteristics
Safety and Immunogenicity of Norovirus Bivalent Virus-Like Particle Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=153 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=147 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=154 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
Total
n=454 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.9 years
STANDARD_DEVIATION 8.87 • n=5 Participants
|
33.4 years
STANDARD_DEVIATION 9.26 • n=7 Participants
|
34.0 years
STANDARD_DEVIATION 8.78 • n=5 Participants
|
33.5 years
STANDARD_DEVIATION 8.96 • n=4 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
253 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
34 participants
n=5 Participants
|
38 participants
n=7 Participants
|
46 participants
n=5 Participants
|
118 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic and Latino
|
117 participants
n=5 Participants
|
109 participants
n=7 Participants
|
107 participants
n=5 Participants
|
333 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
41 participants
n=5 Participants
|
49 participants
n=7 Participants
|
47 participants
n=5 Participants
|
137 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
100 participants
n=5 Participants
|
91 participants
n=7 Participants
|
94 participants
n=5 Participants
|
285 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
153 participants
n=5 Participants
|
147 participants
n=7 Participants
|
154 participants
n=5 Participants
|
454 participants
n=4 Participants
|
|
Height
|
169.91 cm
STANDARD_DEVIATION 9.228 • n=5 Participants
|
168.89 cm
STANDARD_DEVIATION 9.670 • n=7 Participants
|
171.24 cm
STANDARD_DEVIATION 9.859 • n=5 Participants
|
170.03 cm
STANDARD_DEVIATION 9.616 • n=4 Participants
|
|
Weight
|
76.50 kg
STANDARD_DEVIATION 14.924 • n=5 Participants
|
75.56 kg
STANDARD_DEVIATION 14.720 • n=7 Participants
|
76.91 kg
STANDARD_DEVIATION 15.598 • n=5 Participants
|
76.33 kg
STANDARD_DEVIATION 15.068 • n=4 Participants
|
|
Body Mass Index (BMI)
|
26.40 kg/m^2
STANDARD_DEVIATION 4.125 • n=5 Participants
|
26.44 kg/m^2
STANDARD_DEVIATION 4.427 • n=7 Participants
|
26.14 kg/m^2
STANDARD_DEVIATION 4.313 • n=5 Participants
|
26.32 kg/m^2
STANDARD_DEVIATION 4.281 • n=4 Participants
|
PRIMARY outcome
Timeframe: Days 1 through 7Population: Safety Analysis Set included all participants who received at least one dose of trial vaccination.
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after the primary injection.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=153 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=145 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=154 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the First Injection
Any Solicited Local AEs
|
7.8 percentage of participants
|
64.1 percentage of participants
|
72.7 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the First Injection
Pain
|
7.8 percentage of participants
|
64.1 percentage of participants
|
72.7 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the First Injection
Erythema
|
0 percentage of participants
|
0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the First Injection
Induration
|
0 percentage of participants
|
1.4 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the First Injection
Swelling
|
0 percentage of participants
|
2.1 percentage of participants
|
0.6 percentage of participants
|
PRIMARY outcome
Timeframe: Days 1 through 7Population: Safety Analysis Set included all participants who received at least one dose of trial vaccination.
Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after the primary injection.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=153 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=145 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=154 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the First Injection
Any Solicited Systemic AEs
|
26.8 percentage of participants
|
33.1 percentage of participants
|
45.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the First Injection
Headache
|
16.3 percentage of participants
|
15.9 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the First Injection
Fatigue
|
17.0 percentage of participants
|
15.9 percentage of participants
|
16.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the First Injection
Myalgia
|
7.2 percentage of participants
|
19.3 percentage of participants
|
25.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the First Injection
Arthralgia
|
3.3 percentage of participants
|
4.8 percentage of participants
|
7.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the First Injection
Vomiting
|
1.3 percentage of participants
|
1.4 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the First Injection
Diarrhea
|
7.8 percentage of participants
|
7.6 percentage of participants
|
10.4 percentage of participants
|
PRIMARY outcome
Timeframe: Days 1 through 7Population: Safety Analysis Set included all participants who received at least one dose of trial vaccination.
Fever is defined as greater than or equal to 38°C (100.4°F). Oral body temperature measurement was performed using the thermometer provided by the site for 7 days after each injection. The highest body temperature observed each day was recorded on the Diary Card also provided by the site.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=153 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=145 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=154 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With Elevated Daily Oral Temperature (Fever) After the First Injection
|
0 percentage of participants
|
0.7 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Days 1 through 28Population: Safety Analysis Set included all participants who received at least one dose of trial vaccination.
Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=153 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=145 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=154 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With Unsolicited Adverse Events (AEs) After the First Injection
|
23.5 percentage of participants
|
16.6 percentage of participants
|
21.4 percentage of participants
|
PRIMARY outcome
Timeframe: From first injection (Day 1) to second injection pre-dose (Up to Day 365)Population: Safety Analysis Set included all participants who received at least one dose of trial vaccination.
A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=153 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=145 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=154 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) After the First Injection
|
1.3 percentage of participants
|
2.1 percentage of participants
|
3.2 percentage of participants
|
PRIMARY outcome
Timeframe: From second injection (Day 365) to 6 months after second injection (Up to Day 545)Population: Participants from the Safety Analysis Set who received a second injection.
A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=126 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=109 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=116 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) After the Second Injection
|
1.6 percentage of participants
|
0.9 percentage of participants
|
0.9 percentage of participants
|
PRIMARY outcome
Timeframe: From first injection (Day 1) to second injection pre-dose (Up to Day 365)Population: Safety Analysis Set included all participants who received at least one dose of trial vaccination.
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 |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=153 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=145 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=154 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events of Special Interest (AESI) After the First Injection
|
1.3 percentage of participants
|
2.1 percentage of participants
|
1.3 percentage of participants
|
PRIMARY outcome
Timeframe: From second injection (Day 365) to 6 months after second injection (Up to Day 545)Population: Participants from the Safety Analysis Set who received a second injection.
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 |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=126 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=109 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=116 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events of Special Interest (AESI) After the Second Injection
|
3.2 percentage of participants
|
0 percentage of participants
|
0.9 percentage of participants
|
PRIMARY outcome
Timeframe: Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)Population: Safety Analysis Set included all participants who received at least one dose of trial vaccination.
Withdrawal due to an AE occurred if the participant experienced an AE that required early termination because continued participation imposed an unacceptable risk to the participant's health or the participant was unwilling to continue because of the AE.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=153 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=145 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=154 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study
|
1.3 percentage of participants
|
1.4 percentage of participants
|
2.6 percentage of participants
|
SECONDARY outcome
Timeframe: Days 365 through 371Population: Participants from the Safety Analysis Set who received a second injection.
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after the vaccination on Day 365.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=126 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=109 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=116 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the Second Injection
Any Solicited Local AEs
|
41.3 percentage of participants
|
41.3 percentage of participants
|
44.0 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the Second Injection
Pain
|
41.3 percentage of participants
|
41.3 percentage of participants
|
44.0 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the Second Injection
Erythema
|
0.8 percentage of participants
|
0.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the Second Injection
Induration
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the Second Injection
Swelling
|
0 percentage of participants
|
2.8 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 365 through 371Population: Participants from the Safety Analysis Set who received a second injection.
Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after the vaccination on Day 365.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=126 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=109 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=116 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the Second Injection
Any Solicited Systemic AEs
|
28.6 percentage of participants
|
25.7 percentage of participants
|
31.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the Second Injection
Headache
|
11.9 percentage of participants
|
11.0 percentage of participants
|
14.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the Second Injection
Fatigue
|
11.1 percentage of participants
|
14.7 percentage of participants
|
17.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the Second Injection
Myalgia
|
15.1 percentage of participants
|
15.6 percentage of participants
|
14.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the Second Injection
Arthralgia
|
0.8 percentage of participants
|
7.3 percentage of participants
|
6.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the Second Injection
Vomiting
|
2.4 percentage of participants
|
1.8 percentage of participants
|
1.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the Second Injection
Diarrhea
|
4.0 percentage of participants
|
7.3 percentage of participants
|
8.6 percentage of participants
|
SECONDARY outcome
Timeframe: Days 365 through 371Population: Participants from the Safety Analysis Set who received a second injection.
Fever is defined as greater than or equal to 38°C (100.4°F). Oral body temperature measurement was performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day was recorded on the Diary Card also provided by the site.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=126 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=109 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=116 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With Elevated Daily Oral Temperature (Fever) After the Second Injection
|
0 percentage of participants
|
0.9 percentage of participants
|
2.6 percentage of participants
|
SECONDARY outcome
Timeframe: Days 365 through 393Population: Participants from the Safety Analysis Set who received a second injection.
Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=126 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=109 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=116 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With Unsolicited Adverse Events (AEs) After the Second Injection
|
20.6 percentage of participants
|
14.7 percentage of participants
|
14.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=151 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=140 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=151 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With a Seroresponse in Both Serum Anti-norovirus GI.1 VLP and GII.4 VLP (Pan-Ig ELISA)
|
2.6 percentage of participants
Interval 0.7 to 6.6
|
70.7 percentage of participants
Interval 62.4 to 78.1
|
64.9 percentage of participants
Interval 56.7 to 72.5
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-Like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=151 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=140 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=151 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With a Seroresponse in Serum Anti-norovirus GI.1 VLP (Pan-Ig ELISA)
|
8.6 percentage of participants
Interval 4.7 to 14.3
|
91.4 percentage of participants
Interval 85.5 to 95.5
|
90.1 percentage of participants
Interval 84.1 to 94.3
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particles (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=151 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=140 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=151 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With a Seroresponse in Serum Anti-norovirus GII.4 VLP (Pan-Ig ELISA)
|
4.6 percentage of participants
Interval 1.9 to 9.3
|
75.0 percentage of participants
Interval 67.0 to 81.9
|
69.5 percentage of participants
Interval 61.5 to 76.8
|
SECONDARY outcome
Timeframe: Day 28Population: Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by Pan-Ig ELISA.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=151 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=140 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=151 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
|
366.8 titer
Standard Deviation 6.29
|
13023.2 titer
Standard Deviation 3.40
|
18711.8 titer
Standard Deviation 3.84
|
SECONDARY outcome
Timeframe: Day 28Population: Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by Pan-Ig ELISA.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=151 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=140 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=151 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
|
955.5 titer
Standard Deviation 5.08
|
11275.5 titer
Standard Deviation 2.38
|
8667.9 titer
Standard Deviation 2.84
|
SECONDARY outcome
Timeframe: Day 28Population: Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by Pan-Ig ELISA.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=151 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=140 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=151 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
|
1.3 ratio
Standard Deviation 3.81
|
37.6 ratio
Standard Deviation 6.11
|
55.9 ratio
Standard Deviation 5.90
|
SECONDARY outcome
Timeframe: Day 28Population: Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by Pan-Ig ELISA.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=151 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=140 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=151 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
|
1.1 ratio
Standard Deviation 2.08
|
10.7 ratio
Standard Deviation 4.35
|
7.4 ratio
Standard Deviation 3.46
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data available for this outcome measure.
Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=151 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=139 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=151 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With a Seroresponse in Both Serum Anti-norovirus GI.1 VLP and GII.4 VLP (HBGA)
|
2.0 percentage of participants
Interval 0.4 to 5.7
|
55.4 percentage of participants
Interval 46.7 to 63.8
|
55.0 percentage of participants
Interval 46.7 to 63.1
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-Like particle (VLP) as measured by HBGA binding assay.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=151 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=140 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=151 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With a Seroresponse in Serum GI.1 VLP Antibody Titers (HBGA)
|
3.3 percentage of participants
Interval 1.1 to 7.6
|
74.3 percentage of participants
Interval 66.2 to 81.3
|
80.8 percentage of participants
Interval 73.6 to 86.7
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data for this outcome measure
Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-Like particle (VLP) as measured by HBGA binding assay.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=151 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=139 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=151 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Percentage of Participants With a Seroresponse in Serum GII.4 VLP Antibody Titers (HBGA)
|
2.6 percentage of participants
Interval 0.7 to 6.6
|
71.2 percentage of participants
Interval 62.9 to 78.6
|
68.2 percentage of participants
Interval 60.1 to 75.5
|
SECONDARY outcome
Timeframe: Day 28Population: Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=151 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=140 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=151 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)
|
20.7 titer
Standard Deviation 2.38
|
170.9 titer
Standard Deviation 3.90
|
207.8 titer
Standard Deviation 3.94
|
SECONDARY outcome
Timeframe: Day 28Population: Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data available for this outcome measure.
Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=151 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=139 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=151 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Blocking Titers 50 (BT50) of Anti-Norovirus GII.4 VLP Antibody Titers (HBGA)
|
80.1 titer
Standard Deviation 4.33
|
804.3 titer
Standard Deviation 3.32
|
631.3 titer
Standard Deviation 3.05
|
SECONDARY outcome
Timeframe: Day 28Population: Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=151 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=140 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=151 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)
|
1.1 ratio
Standard Deviation 1.69
|
8.9 ratio
Standard Deviation 3.64
|
10.5 ratio
Standard Deviation 3.56
|
SECONDARY outcome
Timeframe: Day 28Population: Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data available for this outcome measure.
Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay.
Outcome measures
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=151 Participants
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=139 Participants
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=151 Participants
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)
|
1.0 ratio
Standard Deviation 1.77
|
9.7 ratio
Standard Deviation 4.03
|
7.3 ratio
Standard Deviation 3.23
|
Adverse Events
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
Serious events: 4 serious events
Other events: 33 other events
Deaths: 0 deaths
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=153 participants at risk
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=145 participants at risk
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=154 participants at risk
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.69%
1/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Retinal detachment
|
0.65%
1/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site pain
|
0.00%
0/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.69%
1/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.69%
1/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.69%
1/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.69%
1/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.65%
1/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.69%
1/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Neuralgic amyotrophy
|
0.00%
0/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.65%
1/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.69%
1/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.69%
1/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Schizophrenia
|
0.65%
1/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)
n=153 participants at risk
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A \[MPL\]), on Day 365.
|
GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=145 participants at risk
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
|
GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
n=154 participants at risk
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.6%
7/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
3/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
5/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
3/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
4/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.9%
3/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
3/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
3/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
1.3%
2/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.69%
1/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site bruising
|
2.6%
4/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.69%
1/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site pain
|
0.00%
0/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
3/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
2/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
4/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
5/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
4/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.4%
2/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.65%
1/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
5/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
3/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
7.2%
11/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
5/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.5%
10/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
1.3%
2/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
3/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
1/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Sinus headache
|
1.3%
2/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
4/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
4/153 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.69%
1/145 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
2/154 • Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER