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Trial record 39 of 141 for:    MPL

Bivalent Norovirus Vaccine Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01168401
Recruitment Status : Completed
First Posted : July 23, 2010
Results First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Gastroenteritis
Interventions Biological: NoV GI.1/GII.4 Bivalent VLP Vaccine
Biological: Saline
Enrollment 102
Recruitment Details Participants took part in the study at 3 investigative sites in the United States from 03 September 2010 to 09 January 2013.
Pre-assignment Details Healthy volunteers were enrolled in 1 of the following treatment groups: Bivalent Norovirus GI.1/GII.4 Vaccine (Cohort A: 5/5 microgram [mcg], 15/15 mcg, 50/50 mcg, 150/150 mcg; Cohort B: 50/50 mcg; Cohort C: 50/50 mcg and Cohort D: 50/50 mcg) adjuvanted with 50 mcg monophosphoryl lipid A (MPL) and 500 mcg aluminum hydroxide [Al(OH)3]) or Placebo.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description Norovirus bivalent Virus-Like Particle (VLP) Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years. Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years. Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years. Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years. Norovirus Bivalent VLP Placebo-matching injection (0.9 percent [%] sodium chloride [NaCl] and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years. Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years. Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years. Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years. Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years. Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years. Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Period Title: Overall Study
Started 10 10 10 9 9 9 10 10 9 8 8
Completed 9 9 8 7 9 9 10 10 9 8 8
Not Completed 1 1 2 2 0 0 0 0 0 0 0
Reason Not Completed
Lost to Follow-up             1             1             2             1             0             0             0             0             0             0             0
Withdrawal by Subject             0             0             0             1             0             0             0             0             0             0             0
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo Total
Hide Arm/Group Description Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years. Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years. Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years. Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years. Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years. Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years. Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years. Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years. Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years. Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years. Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years. Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 9 9 9 10 10 9 8 8 102
Hide Baseline Analysis Population Description
Modified Intent to Treat (mITT) population included all participants who received at least 1 dose of study product.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 9 participants 9 participants 9 participants 10 participants 10 participants 9 participants 8 participants 8 participants 102 participants
Greater than or equal to (>=) 18 and <64 years 10 10 10 9 9 9 10 0 0 8 8 83
>=65 years 0 0 0 0 0 0 0 10 9 0 0 19
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 9 participants 9 participants 9 participants 10 participants 10 participants 9 participants 8 participants 8 participants 102 participants
Female
7
  70.0%
6
  60.0%
7
  70.0%
7
  77.8%
8
  88.9%
5
  55.6%
5
  50.0%
8
  80.0%
5
  55.6%
3
  37.5%
7
  87.5%
68
  66.7%
Male
3
  30.0%
4
  40.0%
3
  30.0%
2
  22.2%
1
  11.1%
4
  44.4%
5
  50.0%
2
  20.0%
4
  44.4%
5
  62.5%
1
  12.5%
34
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 10 participants 9 participants 9 participants 9 participants 10 participants 10 participants 9 participants 8 participants 8 participants 102 participants
10 10 10 9 9 9 10 10 9 8 8 102
Race  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 9 participants 9 participants 9 participants 10 participants 10 participants 9 participants 8 participants 8 participants 102 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.0%
Asian
0
   0.0%
0
   0.0%
2
  20.0%
2
  22.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
   3.9%
Black or African American
2
  20.0%
2
  20.0%
2
  20.0%
1
  11.1%
2
  22.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5
  62.5%
5
  62.5%
19
  18.6%
White
8
  80.0%
7
  70.0%
6
  60.0%
6
  66.7%
7
  77.8%
9
 100.0%
9
  90.0%
10
 100.0%
9
 100.0%
3
  37.5%
2
  25.0%
76
  74.5%
More than one race
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
2
   2.0%
Ethnicity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 9 participants 9 participants 9 participants 10 participants 10 participants 9 participants 8 participants 8 participants 102 participants
Non-Hispanic
8
  80.0%
10
 100.0%
10
 100.0%
9
 100.0%
9
 100.0%
9
 100.0%
9
  90.0%
10
 100.0%
9
 100.0%
6
  75.0%
8
 100.0%
97
  95.1%
Hispanic
2
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
2
  25.0%
0
   0.0%
5
   4.9%
Saliva Secretor Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 9 participants 9 participants 9 participants 10 participants 10 participants 9 participants 8 participants 8 participants 102 participants
Saliva Secretor Status Positive
7
  70.0%
8
  80.0%
6
  60.0%
9
 100.0%
8
  88.9%
6
  66.7%
8
  80.0%
8
  80.0%
7
  77.8%
7
  87.5%
5
  62.5%
79
  77.5%
Saliva Secretor Status Negative
3
  30.0%
2
  20.0%
4
  40.0%
0
   0.0%
1
  11.1%
3
  33.3%
2
  20.0%
2
  20.0%
2
  22.2%
1
  12.5%
3
  37.5%
23
  22.5%
Blood Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 9 participants 9 participants 9 participants 10 participants 10 participants 9 participants 8 participants 8 participants 102 participants
Blood Type A
3
  30.0%
3
  30.0%
5
  50.0%
3
  33.3%
2
  22.2%
2
  22.2%
6
  60.0%
3
  30.0%
2
  22.2%
1
  12.5%
2
  25.0%
32
  31.4%
Blood Type B
0
   0.0%
1
  10.0%
0
   0.0%
1
  11.1%
1
  11.1%
2
  22.2%
0
   0.0%
0
   0.0%
2
  22.2%
2
  25.0%
2
  25.0%
11
  10.8%
Blood Type O
6
  60.0%
4
  40.0%
5
  50.0%
5
  55.6%
5
  55.6%
5
  55.6%
3
  30.0%
7
  70.0%
5
  55.6%
5
  62.5%
3
  37.5%
53
  52.0%
Blood Type AB
1
  10.0%
2
  20.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
6
   5.9%
1.Primary Outcome
Title Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1
Hide Description The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfere with activity); Moderate (repeated use of non-narcotic pain reliever greater than (>) 24 hours [24h] or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 centimeter [cm] and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (>10 cm or prevented daily activity).
Time Frame Day 0 up to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 10 10 10 9 9 9 10 10 9 8 8
Measure Type: Number
Unit of Measure: participants
Pain: Mild 4 5 6 5 1 5 0 4 0 4 0
Pain: Moderate 4 2 2 2 0 2 0 0 0 0 0
Tenderness: Mild 4 5 6 5 1 4 1 6 0 3 2
Tenderness: Moderate 3 4 2 2 0 2 0 0 0 1 0
Swelling: Mild 1 2 2 1 0 1 1 1 0 3 3
2.Primary Outcome
Title Number of Participants With Solicited Local AEs Post Dose 2
Hide Description The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfered with activity); Moderate (repeated use of non-narcotic pain reliever >24h or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 cm and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (>10 cm or prevented daily activity).
Time Frame Day 28 up to Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population where Day 28 to 35 assessment were available for this measure. mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 9 7 10 8 8 8 10 9 9 8 7
Measure Type: Number
Unit of Measure: participants
Pain: Mild 5 4 4 2 0 3 0 5 0 3 1
Pain: Moderate 3 1 0 0 0 2 0 0 0 1 0
Tenderness: Mild 7 6 6 3 1 6 1 4 0 5 2
Tenderness: Moderate 1 1 0 0 0 1 0 0 0 0 0
Swelling: Mild 0 0 1 1 0 0 0 0 0 4 5
Swelling: Moderate 1 0 0 0 0 0 0 0 0 0 0
Redness: Mild 1 0 0 0 0 0 0 0 0 0 0
3.Primary Outcome
Title Number of Participants With Solicited Systemic AEs Post Dose 1
Hide Description Elevated oral temperature:Mild(38-38.4 Celsius[C]);Moderate(38.5-38.9 C);Severe(39-40 C).Headache:Mild(no interference with activity);Moderate(repeated use of non-narcotic pain reliever>24h/some interference with activity);Severe(significant;any use of narcotic pain reliever/prevented daily activity).Fatigue,Malaise:Mild(no interference with activity);Moderate(some interference with activity);Severe(significant;prevented daily activity).Diarrhea:Mild(2-3loose stools/<400gram[g]/24h);Moderate(4-5stools/400-800g/24h);Severe(>=6watery stools/>800g/24h/required intravenous[IV]hydration).Nausea/Vomiting:Mild(no interference with activity/1-2 episodes/24h);Moderate(some interference with activity/>2 episodes/24h);Severe(prevented daily activity,required IV hydration).Muscle ache,chills,joint ache,abdominal cramp/pain:Mild(no interference with activity);Moderate(some interference with activity,not required medical intervention);Severe(prevented daily activity,required medical intervention).
Time Frame Day 0 up to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 10 10 10 9 9 9 10 10 9 8 8
Measure Type: Number
Unit of Measure: participants
Headache: Mild 1 3 3 2 2 5 0 2 2 0 2
Headache: Moderate 3 1 0 1 0 0 0 0 0 0 1
Fatigue/ Malaise: Mild 1 1 1 1 0 2 1 0 0 0 1
Fatigue/ Malaise: Moderate 4 1 1 0 0 0 0 0 0 0 0
Muscle Aches : Mild 4 2 1 3 1 0 0 0 0 0 0
Muscle Aches : Moderate 1 0 1 0 0 0 0 1 0 0 0
Joint Aches: Mild 1 1 0 0 0 0 0 0 0 0 0
Joint Aches: Moderate 2 0 1 0 0 0 0 0 0 0 0
Nausea: Mild 1 1 2 1 1 1 1 0 1 0 0
Nausea: Moderate 2 0 0 0 0 0 0 0 0 0 0
Abdominal Cramps/Discomfort: Mild 2 0 1 2 0 0 0 1 1 1 0
Abdominal Cramps/Discomfort: Moderate 2 0 0 0 1 0 1 0 0 0 0
Chills: Mild 1 0 1 0 0 0 0 0 0 0 0
Chills: Moderate 1 0 1 0 0 0 0 0 0 0 0
Vomiting: Moderate 1 0 0 0 0 0 0 0 0 0 0
Diarrhea: Mild 2 0 1 1 0 0 0 1 1 1 2
Diarrhea: Moderate 1 0 0 0 0 0 1 0 0 0 0
Diarrhea: Severe 0 0 0 0 1 0 0 0 0 0 0
4.Primary Outcome
Title Number of Participants With Solicited Systemic AEs Post Dose 2
Hide Description Elevated oral temperature:Mild(38-38.4 C);Moderate(38.5-38.9 C);Severe(39-40 C).Headache:Mild(no interference with activity);Moderate(repeated use of non-narcotic pain reliever>24h/some interference with activity);Severe(significant;any use of narcotic pain reliever/prevented daily activity).Fatigue,Malaise:Mild(no interference with activity);Moderate(some interference with activity);Severe(significant;prevented daily activity).Diarrhea:Mild(2-3loose stools/<400g/24h);Moderate(4-5stools/400-800g/24h);Severe(>=6watery stools/>800g/24h/required IV hydration).Nausea/Vomiting:Mild(no interference with activity/1-2 episodes/24h);Moderate(some interference with activity/>2 episodes/24h);Severe(prevented daily activity,required IV hydration).Muscle ache,chills,joint ache,abdominal cramp/pain:Mild(no interference with activity);Moderate(some interference with activity,not required medical intervention);Severe(prevented daily activity,required medical intervention).
Time Frame Day 28 up to Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population where Day 28 to 35 assessment were available for this measure. mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 9 7 10 8 8 8 10 9 9 8 7
Measure Type: Number
Unit of Measure: participants
Headache: Mild 1 1 3 2 1 3 0 1 1 1 1
Headache: Moderate 2 0 1 0 0 0 0 0 0 0 1
Headache: Severe 0 0 0 0 0 0 0 1 0 0 0
Fatigue/ Malaise: Mild 1 0 3 0 1 2 0 0 0 0 0
Fatigue/ Malaise: Moderate 2 0 0 0 0 0 0 0 0 0 1
Muscle Aches: Mild 2 1 3 1 0 0 0 0 0 0 0
Muscle Aches: Moderate 1 0 0 0 0 0 0 0 1 0 0
Joint Aches: Mild 1 0 0 0 0 0 0 0 0 0 0
Joint Aches: Moderate 0 0 0 0 0 0 0 0 1 0 0
Nausea: Mild 1 0 0 0 0 1 0 0 0 0 0
Nausea: Moderate 1 0 0 0 0 0 0 0 0 0 0
Abdominal Cramps/Discomfort: Mild 1 1 1 2 0 1 1 0 0 0 0
Chills: Mild 0 0 1 0 0 0 0 0 0 0 0
Chills: Moderate 1 0 0 0 0 0 0 0 0 0 0
Diarrhea: Mild 0 0 0 0 0 0 1 0 0 0 0
Diarrhea: Severe 1 0 0 0 0 0 0 0 0 0 0
5.Primary Outcome
Title Number of Participants With Unsolicited AEs Post Dose 1
Hide Description [Not Specified]
Time Frame Baseline up to Day 28 (Pre-dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who received at least 1 dose of study product.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 10 10 10 9 9 9 10 10 9 8 8
Measure Type: Number
Unit of Measure: participants
7 4 4 1 2 4 0 3 3 3 4
6.Primary Outcome
Title Number of Participants With Unsolicited AEs Post Dose 2
Hide Description [Not Specified]
Time Frame Day 28 up to Day 56 (Post dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population where Day 28 to 56 assessment were available for this measure. mITT population included all participants who received at least 1 dose of study product.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 9 7 10 8 8 8 10 9 9 8 7
Measure Type: Number
Unit of Measure: participants
2 1 2 2 2 3 3 2 2 3 1
7.Primary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values
Hide Description The number of participants with any markedly abnormal standard safety laboratory values (serum chemistry or hematology) collected throughout study.
Time Frame Baseline up to Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who received at least 1 dose of study product.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 10 10 10 9 9 9 10 10 9 8 8
Measure Type: Number
Unit of Measure: participants
0 3 1 0 0 0 0 0 0 0 2
8.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI)
Hide Description [Not Specified]
Time Frame Baseline up to 365 Days after post dose 2 (Day 393)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who received at least 1 dose of study product.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 10 10 10 9 9 9 10 10 9 8 8
Measure Type: Number
Unit of Measure: participants
SAE 1 0 1 0 0 0 1 2 0 0 0
New Medical Conditions 0 0 0 0 0 0 0 0 0 0 0
9.Secondary Outcome
Title Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
Hide Description Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time Frame First (I) run: predose 1 and 7, 21, 28 days postdose (PD)1, and 7 and 28 days PD2; second (II) run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 9 8 10 8 9 8 10 9 9 8 7
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
GI.1: I Run: Pre-Dose 1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
9
(3 to 26)
5
(3 to 7)
5
(3 to 10)
6
(3 to 13)
10
(3 to 32)
3 [1] 
(NA to NA)
5
(3 to 8)
5
(3 to 9)
4
(3 to 5)
3
(3 to 3)
3 [1] 
(NA to NA)
GI.1: I Run:7 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 7 participants 9 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
204
(126 to 332)
357
(141 to 906)
458
(97 to 2154)
675
(136 to 3334)
7
(2 to 20)
357
(110 to 1158)
5
(3 to 8)
208
(48 to 903)
4
(3 to 5)
40
(13 to 120)
3 [1] 
(NA to NA)
GI.1: I Run:21 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 9 participants 8 participants 9 participants 8 participants 8 participants 8 participants 7 participants
164
(87 to 311)
164
(71 to 379)
269
(90 to 799)
307
(84 to 1115)
9
(3 to 26)
252
(151 to 421)
5
(3 to 9)
114
(31 to 423)
4
(3 to 5)
31
(10 to 96)
3 [1] 
(NA to NA)
GI.1: I Run:28 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 9 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
143
(70 to 293)
106
(42 to 267)
183
(61 to 544)
149
(43 to 517)
9
(3 to 23)
178
(95 to 335)
5
(3 to 8)
104
(29 to 375)
4
(3 to 5)
21
(7 to 60)
3 [1] 
(NA to NA)
GI.1: I Run:7 Days PD2 Number Analyzed 9 participants 7 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
134
(62 to 291)
112
(46 to 275)
130
(57 to 294)
131
(45 to 376)
11
(3 to 34)
140
(73 to 270)
5
(3 to 8)
105
(33 to 329)
4
(3 to 5)
19
(7 to 55)
3 [1] 
(NA to NA)
GI.1: I Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
115
(55 to 243)
80
(28 to 224)
70
(24 to 202)
78
(20 to 310)
10
(3 to 29)
97
(48 to 198)
5
(3 to 8)
76
(23 to 251)
4
(3 to 5)
17
(7 to 42)
3 [1] 
(NA to NA)
GI.1: II Run:Pre-Dose 1 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
5
(2 to 9)
3 [1] 
(NA to NA)
3 [1] 
(NA to NA)
3
(3 to 4)
6
(2 to 18)
3 [1] 
(NA to NA)
6
(3 to 12)
6
(3 to 13)
5
(3 to 9)
4
(2 to 6)
3 [1] 
(NA to NA)
GI.1: II Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
32
(13 to 81)
15
(7 to 33)
11
(6 to 21)
16
(6 to 43)
6
(2 to 18)
120
(62 to 231)
6
(3 to 11)
154
(68 to 348)
5
(3 to 8)
35
(13 to 99)
3
(3 to 5)
GI.1: II Run:152 Days PD2 Number Analyzed 8 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
17
(6 to 47)
13
(6 to 26)
10
(6 to 19)
16
(6 to 43)
6
(2 to 18)
57
(36 to 92)
6
(3 to 12)
78
(42 to 143)
6
(4 to 10)
24
(10 to 58)
3
(3 to 4)
GI.1: II Run:365 Days PD2 Number Analyzed 6 participants 7 participants 8 participants 7 participants 8 participants 8 participants 10 participants 9 participants 9 participants 7 participants 7 participants
23
(6 to 92)
11
(6 to 22)
8
(5 to 14)
14
(4 to 44)
5
(2 to 13)
38
(22 to 65)
6
(3 to 12)
53
(29 to 99)
7
(4 to 13)
16
(7 to 39)
3 [1] 
(NA to NA)
GII.4: I Run: Pre-Dose 1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
21
(7 to 63)
13
(5 to 34)
5
(2 to 12)
9
(4 to 20)
23
(7 to 70)
9
(3 to 29)
5
(3 to 7)
9
(4 to 23)
6
(3 to 12)
5
(2 to 9)
6
(3 to 12)
GII.4: I Run:7 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 7 participants 9 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
140
(92 to 213)
193
(87 to 432)
57
(24 to 138)
52
(35 to 78)
18
(6 to 53)
92
(26 to 322)
5
(3 to 8)
41
(26 to 65)
7
(3 to 14)
96
(22 to 421)
6
(3 to 13)
GII.4: I Run:21 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 7 participants
120
(95 to 151)
113
(53 to 239)
27
(8 to 93)
25
(14 to 42)
16
(6 to 45)
63
(21 to 186)
5
(3 to 9)
25
(9 to 70)
7
(3 to 16)
55
(18 to 170)
6
(3 to 13)
GII.4: I Run:28 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 9 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
116
(84 to 161)
68
(32 to 149)
19
(6 to 61)
19
(10 to 34)
19
(7 to 48)
42
(11 to 159)
5
(3 to 7)
22
(9 to 55)
6
(3 to 12)
39
(15 to 100)
6
(3 to 12)
GII.4: I Run:7 Days PD2 Number Analyzed 9 participants 7 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
108
(73 to 160)
94
(44 to 202)
17
(6 to 48)
22
(10 to 50)
29
(12 to 72)
44
(12 to 159)
5
(3 to 8)
22
(9 to 55)
7
(3 to 14)
36
(15 to 89)
6
(3 to 11)
GII.4: I Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
108
(79 to 149)
76
(36 to 174)
19
(7 to 54)
19
(9 to 39)
30
(12 to 76)
34
(10 to 117)
5
(3 to 7)
21
(9 to 53)
6
(3 to 14)
31
(13 to 73)
6
(3 to 13)
GII.4: II Run:Pre-Dose 1 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
8
(4 to 17)
4
(2 to 7)
4
(2 to 11)
8
(4 to 17)
5
(2 to 10)
9
(3 to 28)
5
(3 to 8)
18
(5 to 66)
8
(4 to 17)
5
(2 to 12)
7
(3 to 16)
GII.4: II Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
39
(22 to 71)
32
(17 to 60)
17
(7 to 42)
19
(12 to 31)
7
(3 to 20)
38
(11 to 125)
5
(3 to 9)
44
(13 to 144)
8
(4 to 19)
42
(20 to 89)
7
(3 to 16)
GII.4: II Run:152 Days PD2 Number Analyzed 8 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
25
(11 to 54)
20
(9 to 44)
9
(4 to 23)
14
(7 to 28)
6
(3 to 15)
27
(9 to 83)
6
(3 to 11)
29
(10 to 85)
9
(4 to 19)
25
(10 to 65)
6
(3 to 13)
GII.4: II Run:365 Days PD2 Number Analyzed 6 participants 7 participants 8 participants 7 participants 8 participants 8 participants 10 participants 9 participants 9 participants 7 participants 7 participants
16
(5 to 45)
13
(5 to 38)
8
(3 to 22)
16
(9 to 29)
6
(3 to 11)
17
(5 to 56)
7
(3 to 18)
24
(9 to 66)
11
(4 to 28)
19
(7 to 47)
6
(3 to 13)
[1]
Confidence interval could not be calculated because there was no variance in the observed data.
10.Secondary Outcome
Title GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
Hide Description Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time Frame I run: predose 1 and 7, 21, 28 days PD1, and 7 and 28 days PD2; II run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)
Hide Outcome Measure Data
Hide Analysis Population Description
PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 9 8 10 8 9 8 10 9 9 8 7
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
GI.1: I Run: Pre-Dose 1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
13
(3 to 55)
8
(2 to 27)
28
(11 to 73)
22
(7 to 68)
9
(2 to 37)
9
(3 to 26)
7
(3 to 21)
14
(5 to 38)
11
(4 to 26)
7
(2 to 32)
5
(1 to 14)
GI.1: I Run:7 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 7 participants 9 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
211
(98 to 452)
237
(120 to 466)
1650
(673 to 4047)
1171
(251 to 5457)
5
(1 to 20)
375
(97 to 1447)
7
(2 to 19)
96
(32 to 289)
10
(4 to 24)
82
(18 to 373)
5
(1 to 16)
GI.1: I Run:21 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 9 participants 8 participants 9 participants 8 participants 8 participants 8 participants 7 participants
266
(130 to 545)
184
(93 to 363)
1165
(495 to 2741)
1235
(534 to 2858)
7
(2 to 26)
457
(159 to 1312)
5
(1 to 18)
97
(30 to 309)
13
(5 to 30)
107
(24 to 468)
5
(1 to 14)
GI.1: I Run:28 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 9 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
261
(140 to 486)
152
(76 to 305)
910
(379 to 2185)
878
(409 to 1882)
7
(2 to 26)
429
(178 to 1036)
6
(2 to 18)
110
(41 to 300)
10
(4 to 23)
93
(22 to 395)
5
(2 to 16)
GI.1: I Run:7 Days PD2 Number Analyzed 9 participants 7 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
281
(152 to 520)
167
(77 to 365)
723
(360 to 1452)
957
(554 to 1651)
10
(2 to 49)
513
(249 to 1060)
7
(3 to 21)
157
(66 to 373)
10
(4 to 24)
108
(25 to 474)
5
(2 to 14)
GI.1: I Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
286
(151 to 540)
168
(76 to 346)
605
(256 to 1432)
737
(399 to 1361)
11
(2 to 50)
518
(278 to 966)
6
(2 to 19)
177
(78 to 399)
10
(4 to 26)
127
(27 to 586)
5
(2 to 16)
GI.1: II Run:Pre-Dose 1 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
5
(2 to 14)
7
(3 to 14)
5
(3 to 8)
5
(2 to 10)
7
(2 to 27)
8
(4 to 19)
7
(3 to 14)
9
(3 to 30)
8
(4 to 18)
3
(1 to 6)
3
(1 to 5)
GI.1: II Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
83
(45 to 156)
94
(46 to 192)
89
(44 to 181)
113
(78 to 164)
10
(3 to 36)
270
(178 to 411)
6
(2 to 14)
103
(53 to 200)
8
(4 to 17)
80
(56 to 116)
3
(1 to 6)
GI.1: II Run:152 Days PD2 Number Analyzed 8 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
44
(22 to 91)
65
(43 to 99)
46
(24 to 89)
73
(45 to 118)
8
(2 to 28)
135
(90 to 202)
7
(3 to 16)
82
(47 to 143)
8
(4 to 17)
35
(27 to 44)
3
(1 to 5)
GI.1: II Run:365 Days PD2 Number Analyzed 6 participants 7 participants 8 participants 7 participants 8 participants 8 participants 10 participants 9 participants 9 participants 7 participants 7 participants
58
(26 to 131)
53
(40 to 68)
28
(15 to 54)
46
(23 to 92)
6
(2 to 19)
75
(55 to 103)
6
(2 to 16)
57
(33 to 99)
10
(4 to 28)
21
(13 to 34)
3
(1 to 6)
GII.4: I Run: Pre-Dose 1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
38
(10 to 142)
19
(6 to 62)
5
(2 to 14)
17
(7 to 41)
19
(5 to 69)
8
(2 to 29)
5
(2 to 15)
10
(4 to 28)
6
(2 to 20)
11
(5 to 22)
13
(4 to 45)
GII.4: I Run:7 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 7 participants 9 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
97
(56 to 167)
136
(66 to 279)
43
(30 to 62)
40
(27 to 60)
14
(4 to 53)
54
(14 to 206)
5
(2 to 15)
23
(14 to 37)
9
(3 to 24)
178
(100 to 317)
16
(6 to 46)
GII.4: I Run:21 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 7 participants
142
(70 to 286)
128
(59 to 279)
35
(25 to 50)
39
(27 to 55)
13
(4 to 45)
93
(33 to 262)
5
(2 to 15)
29
(17 to 49)
9
(3 to 28)
180
(126 to 259)
17
(6 to 48)
GII.4: I Run:28 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 9 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
139
(73 to 267)
98
(42 to 225)
31
(22 to 45)
37
(28 to 49)
16
(6 to 46)
86
(31 to 237)
5
(2 to 13)
30
(20 to 45)
7
(2 to 20)
148
(105 to 208)
16
(6 to 45)
GII.4: I Run:7 Days PD2 Number Analyzed 9 participants 7 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
144
(72 to 288)
132
(71 to 248)
34
(28 to 42)
42
(34 to 51)
25
(9 to 69)
99
(42 to 233)
5
(2 to 14)
34
(25 to 45)
8
(3 to 24)
144
(106 to 196)
15
(5 to 46)
GII.4: I Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
174
(90 to 336)
125
(72 to 218)
34
(26 to 46)
41
(32 to 51)
27
(10 to 75)
102
(43 to 242)
6
(2 to 15)
36
(28 to 47)
7
(3 to 21)
140
(97 to 202)
17
(6 to 49)
GII.4: II Run:Pre-Dose 1 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
13
(5 to 31)
11
(4 to 32)
5
(2 to 13)
10
(3 to 33)
5
(2 to 14)
6
(2 to 18)
4
(2 to 9)
9
(2 to 42)
7
(2 to 20)
3
(1 to 7)
6
(2 to 14)
GII.4: II Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
65
(39 to 106)
74
(46 to 120)
57
(35 to 91)
37
(18 to 73)
8
(2 to 34)
104
(65 to 166)
5
(2 to 12)
52
(22 to 120)
7
(2 to 18)
37
(25 to 56)
6
(2 to 15)
GII.4: II Run:152 Days PD2 Number Analyzed 8 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
52
(31 to 87)
44
(22 to 91)
18
(8 to 41)
18
(9 to 36)
7
(2 to 23)
77
(30 to 194)
5
(2 to 11)
33
(14 to 75)
8
(2 to 26)
20
(12 to 33)
5
(2 to 12)
GII.4: II Run:365 Days PD2 Number Analyzed 6 participants 7 participants 8 participants 7 participants 8 participants 8 participants 10 participants 9 participants 9 participants 7 participants 7 participants
28
(11 to 75)
51
(27 to 96)
13
(7 to 25)
23
(11 to 51)
6
(2 to 16)
44
(24 to 81)
6
(2 to 16)
22
(9 to 54)
13
(5 to 34)
16
(8 to 34)
5
(2 to 12)
11.Secondary Outcome
Title GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgM
Hide Description Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time Frame I run: predose 1 and 7, 21, 28 days PD1, and 7 and 28 days PD2; II run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected because serum specimens were not tested for specific IgM antibodies to Norovirus GI.1 and GII.4 VLPs as per the change in planned analysis, because this measurement was not informative in a previous study LV01-103 (NCT00973284).
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
Hide Description Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time Frame I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Hide Outcome Measure Data
Hide Analysis Population Description
PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 9 8 10 8 8 8 10 9 9 8 7
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold rise
GI.1: I Run:7 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 7 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
23.1
(7.4 to 71.9)
76.1
(38.1 to 152)
84.4
(20.6 to 345.1)
122.9
(30 to 503.7)
0.8
(0.3 to 1.8)
115.2
(35.5 to 373.7)
1
(1 to 1)
39.1
(10.3 to 148.2)
1
(1 to 1)
12.6
(4.2 to 37.6)
1 [1] 
(NA to NA)
GI.1: I Run:21 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 9 participants 8 participants 8 participants 8 participants 7 participants
18.5
(7 to 49)
34.9
(16.6 to 73.4)
49.6
(18.2 to 134.9)
52.1
(19.3 to 140.4)
1
(0.9 to 1.2)
81.2
(48.6 to 135.7)
1
(0.9 to 1.1)
24.2
(6.9 to 85.7)
1
(0.9 to 1)
9.7
(3.1 to 30.2)
1 [1] 
(NA to NA)
GI.1: I Run:28 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
16.2
(6.1 to 42.8)
22.6
(11.1 to 46)
33.7
(11.7 to 46)
25.4
(10.5 to 61.3)
1
(0.8 to 1.2)
57.5
(30.6 to 108)
1
(0.9 to 1.1)
19.6
(6.4 to 60.5)
1
(0.9 to 1)
6.6
(2.4 to 18.8)
1 [1] 
(NA to NA)
GI.1: I Run:7 Days PD2 Number Analyzed 9 participants 7 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
15.1
(6.2 to 37)
22.5
(11.8 to 42.9)
23.9
(9.6 to 59.7)
22.2
(10.8 to 45.4)
1.1
(0.7 to 1.6)
45.2
(23.4 to 87.2)
1
(1 to 1.1)
19.7
(7.3 to 53.2)
1
(0.9 to 1)
6
(2.1 to 17.3)
1 [1] 
(NA to NA)
GI.1: I Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
13
(5 to 33.6)
16
(7.4 to 34.5)
12.1
(4.8 to 30.7)
13.2
(5 to 34.7)
1
(0.7 to 1.3)
31.3
(15.4 to 63.7)
1.1
(0.9 to 1.3)
14.2
(5.1 to 39.8)
1
(1 to 1.1)
5.3
(2.1 to 13.1)
1 [1] 
(NA to NA)
GI.1: II Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
7
(3.7 to 13.3)
5
(2.3 to 10.7)
3.6
(1.9 to 6.8)
4.7
(1.9 to 11.7)
1
(1 to 1)
38.6
(19.9 to 74.6)
1
(0.9 to 1.1)
25.5
(9.1 to 71.4)
1
(1 to 1)
9.6
(3.7 to 24.9)
1.1
(0.9 to 1.5)
GI.1: II Run:152 Days PD2 Number Analyzed 8 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
3.6
(1.8 to 7.1)
4.1
(2 to 8.3)
3.3
(1.8 to 6)
4.6
(1.7 to 12)
1
(1 to 1)
18.5
(11.5 to 29.8)
1.1
(0.9 to 1.3)
12.9
(5.5 to 30)
1.1
(0.9 to 1.3)
6.6
(2.9 to 15.1)
1.1
(0.9 to 1.4)
GI.1: II Run:365 Days PD2 Number Analyzed 6 participants 7 participants 8 participants 7 participants 7 participants 8 participants 10 participants 9 participants 9 participants 7 participants 7 participants
4.1
(1.3 to 13.5)
3.7
(1.9 to 7.1)
2.6
(1.6 to 4.4)
4.5
(1.4 to 14.1)
1
(0.9 to 1)
12.2
(7.1 to 20.9)
1
(0.9 to 1.2)
8.8
(3.9 to 20.2)
1.3
(0.9 to 1.9)
5.2
(2.1 to 12.7)
1 [1] 
(NA to NA)
GII.4: I Run:7 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 7 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
6.7
(2.2 to 20.7)
15.4
(4.7 to 50.8)
10.7
(3.5 to 32.9)
5
(2.2 to 11)
1
(0.9 to 1.1)
9.7
(3 to 30.6)
1
(1 to 1.1)
4.4
(2.1 to 9.6)
1.2
(0.9 to 1.4)
19.9
(5.9 to 67.6)
1
(1 to 1.1)
GII.4: I Run:21 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 8 participants 8 participants 8 participants 7 participants
5.7
(2 to 16.5)
9
(4.1 to 20)
5
(1.3 to 18.9)
2.7
(1.3 to 5.5)
0.9
(0.7 to 1)
6.6
(3 to 14.4)
1.1
(0.9 to 1.2)
3.5
(1.2 to 9.7)
1.1
(0.8 to 1.6)
11.4
(3.9 to 33.3)
1
(1 to 1.1)
GII.4: I Run:28 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
5.6
(2.1 to 14.8)
5.5
(2.4 to 12.3)
3.6
(1.1 to 12)
2
(1 to 4.3)
1
(0.6 to 1.9)
4.5
(1.9 to 10.7)
1
(0.9 to 1.1)
2.4
(0.9 to 6.4)
1
(0.8 to 1.2)
8.1
(3.2 to 20.4)
1
(0.9 to 1.1)
GII.4: I Run:7 Days PD2 Number Analyzed 9 participants 7 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
5.2
(2.1 to 12.6)
6.1
(2.9 to 12.7)
3.2
(1.1 to 9.4)
2.5
(1 to 5.9)
1.3
(0.4 to 3.6)
4.6
(2.1 to 10.3)
1.1
(1 to 1.1)
2.4
(0.9 to 6.3)
1.1
(0.9 to 1.5)
7.5
(3 to 18.6)
1
(0.8 to 1.1)
GII.4: I Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
5.2
(2.1 to 12.6)
5.2
(2.6 to 10.2)
3.4
(1.4 to 8.4)
2
(1 to 4.4)
1.3
(0.5 to 3.3)
3.5
(1.7 to 7.4)
1
(1 to 1.1)
2.3
(1 to 5.7)
1.1
(0.9 to 1.4)
6.4
(2.6 to 15.6)
1.1
(1 to 1.2)
GII.4: II Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
4.7
(2.9 to 7.7)
7.5
(4.6 to 12.2)
3.9
(1.6 to 9.1)
2.5
(1 to 5.9)
1.5
(0.6 to 3.6)
4
(1.9 to 8.3)
1.1
(0.9 to 1.4)
2.4
(0.8 to 7.2)
1
(0.9 to 1.2)
8.1
(3.2 to 20.4)
1
(0.9 to 1)
GII.4: II Run:152 Days PD2 Number Analyzed 8 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
2.6
(1.8 to 3.9)
4.8
(2.4 to 9.4)
2
(1 to 4)
1.9
(0.8 to 4.5)
1.3
(0.7 to 2.4)
2.8
(1.5 to 5.2)
1.2
(0.9 to 1.6)
1.6
(0.5 to 4.8)
1.1
(0.9 to 1.4)
4.8
(1.8 to 12.7)
0.8
(0.6 to 1.2)
GII.4: II Run:365 Days PD2 Number Analyzed 6 participants 7 participants 8 participants 7 participants 7 participants 8 participants 10 participants 9 participants 9 participants 7 participants 7 participants
2
(1.2 to 3.2)
3.1
(1.3 to 7.3)
1.7
(0.9 to 3.5)
1.8
(0.8 to 4.2)
1.3
(0.8 to 2.1)
1.8
(0.9 to 3.6)
1.5
(0.9 to 2.6)
1.3
(0.4 to 4.1)
1.4
(0.8 to 2.3)
4.4
(1.6 to 12)
0.8
(0.6 to 1.1)
[1]
Confidence interval could not be calculated because there was no variance in the observed data.
13.Secondary Outcome
Title GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
Hide Description Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time Frame I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Hide Outcome Measure Data
Hide Analysis Population Description
PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 9 8 10 8 8 8 10 9 9 8 7
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold rise
GI.1: I Run:7 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 7 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
16.2
(3.8 to 68.7)
29.4
(11.2 to 77.2)
59.5
(27.2 to 130.2)
54.9
(17.6 to 171)
0.7
(0.2 to 2)
43
(5.9 to 315.7)
0.9
(0.6 to 1.4)
6.8
(2.3 to 20.8)
0.9
(0.8 to 1)
11.2
(2.4 to 52.4)
1
(0.9 to 1.1)
GI.1: I Run:21 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 9 participants 8 participants 8 participants 8 participants 7 participants
20.5
(5.2 to 80.2)
22.8
(8.7 to 59.8)
42
(22.6 to 78.3)
55.2
(25.7 to 118.7)
1
(0.8 to 1.2)
52.5
(10.2 to 270.8)
0.8
(0.5 to 1.2)
7.5
(2.4 to 23.1)
0.9
(0.8 to 1.1)
14.4
(2.9 to 71.8)
1
(0.9 to 1.1)
GI.1: I Run:28 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
20
(4.9 to 81.6)
18.9
(6.8 to 52.6)
32.8
(18.2 to 59.2)
39.2
(17.6 to 87.6)
1
(0.8 to 1.2)
49.3
(11.2 to 217.8)
0.8
(0.5 to 1.3)
7.9
(3.1 to 20.4)
0.9
(0.8 to 1)
12.7
(2.7 to 59.3)
1.1
(0.9 to 1.2)
GI.1: I Run:7 Days PD2 Number Analyzed 9 participants 7 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
21.6
(5.4 to 86.1)
23.8
(9 to 63.2)
26.1
(15.2 to 44.8)
42.8
(17.4 to 104.8)
1.2
(0.7 to 2.1)
59
(14.4 to 241)
1
(0.6 to 1.7)
11.3
(4.3 to 29.8)
0.9
(0.8 to 1)
14.7
(3.1 to 70.3)
1
(0.8 to 1.2)
GI.1: I Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
22
(5.6 to 86.3)
23.1
(8.8 to 60.6)
19.7
(11.8 to 32.9)
32.9
(14.6 to 74.5)
1.2
(0.8 to 1.9)
59.5
(16.9 to 209.6)
0.9
(0.5 to 1.5)
12.6
(4.9 to 32.8)
0.9
(0.9 to 1)
17.2
(3.6 to 82.7)
1.1
(0.9 to 1.2)
GI.1: II Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
17
(4.9 to 59.2)
14.1
(7.9 to 25.3)
18.8
(9.3 to 37.9)
23.9
(14.4 to 39.7)
1.4
(0.8 to 2.5)
32
(14.5 to 70.5)
0.8
(0.6 to 1.3)
10.9
(3.8 to 31)
1
(0.8 to 1.2)
26.6
(11.2 to 63)
1.1
(0.9 to 1.3)
GI.1: II Run:152 Days PD2 Number Analyzed 8 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
7.9
(2.3 to 26.6)
9.8
(5.2 to 18.5)
9.6
(5.1 to 18)
15.5
(7.1 to 33.9)
1.1
(0.7 to 1.9)
15.9
(6.5 to 38.9)
1
(0.7 to 1.4)
8.7
(3.3 to 22.7)
1
(0.7 to 1.3)
11.5
(5.1 to 26)
0.9
(0.6 to 1.3)
GI.1: II Run:365 Days PD2 Number Analyzed 6 participants 7 participants 8 participants 7 participants 7 participants 8 participants 10 participants 9 participants 9 participants 7 participants 7 participants
9.3
(1.7 to 49.5)
7.9
(4.1 to 14.9)
6.1
(3.6 to 10.4)
11.7
(5 to 27.4)
1.1
(0.6 to 2.1)
8.9
(4.1 to 19.3)
0.9
(0.5 to 1.6)
6
(2.4 to 15)
1.3
(0.7 to 2.5)
8.2
(3.6 to 18.6)
1
(0.9 to 1.2)
GII.4: I Run:7 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 7 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
2.6
(0.8 to 8.3)
7.1
(2.4 to 20.3)
8.3
(3.4 to 20.1)
2.4
(1.1 to 5.1)
1
(0.9 to 1.1)
6.8
(2.2 to 21.1)
1
(1 to 1.1)
2.3
(1.2 to 4.4)
1.4
(0.9 to 2)
16.1
(5.7 to 45.4)
1.3
(1 to 1.6)
GII.4: I Run:21 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 8 participants 8 participants 8 participants 7 participants
3.8
(1.1 to 12.8)
6.6
(2.5 to 17.6)
6.8
(2.8 to 16.1)
2.3
(1.2 to 4.2)
0.9
(0.8 to 1)
11.7
(4.7 to 29.2)
1
(0.9 to 1.1)
3.3
(1.4 to 8)
1.3
(0.9 to 1.8)
16.4
(7 to 38.3)
1.4
(1 to 1.8)
GII.4: I Run:28 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
3.7
(1.1 to 12.8)
5.1
(1.9 to 13.4)
6
(2.6 to 14.3)
2.2
(1.1 to 4.4)
1.1
(0.6 to 2.2)
10.8
(4.2 to 27.9)
0.9
(0.9 to 1)
3
(1.4 to 6.4)
1
(0.9 to 1.2)
13.4
(5.7 to 31.6)
1.3
(1 to 1.6)
GII.4: I Run:7 Days PD2 Number Analyzed 9 participants 7 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
3.8
(1.1 to 13.9)
4.8
(1.8 to 12.6)
6.6
(2.7 to 16.1)
2.5
(1.1 to 5.5)
1.4
(0.5 to 4.1)
12.3
(4.6 to 32.6)
1
(0.9 to 1.1)
3.4
(1.4 to 7.9)
1.2
(1 to 1.6)
13.1
(6.1 to 27.8)
1.2
(0.9 to 1.5)
GII.4: I Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
4.6
(1.3 to 16.3)
4.6
(1.8 to 11.6)
5.8
(2.5 to 13.8)
2.4
(1.2 to 5)
1.5
(0.5 to 4.5)
12.8
(4.6 to 35.5)
1.1
(0.9 to 1.3)
3.7
(1.6 to 8.5)
1.1
(0.9 to 1.4)
12.7
(6.3 to 25.5)
1.3
(1 to 1.8)
GII.4: II Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
5
(2.3 to 10.8)
6.8
(2.8 to 16.4)
12
(5.5 to 26.2)
3.5
(1.1 to 11.5)
1.6
(0.5 to 4.5)
18.1
(4.4 to 74.6)
1.3
(1 to 1.6)
5.7
(1.7 to 19.6)
1
(0.7 to 1.5)
12.2
(5.7 to 26.3)
1
(0.9 to 1.2)
GII.4: II Run:152 Days PD2 Number Analyzed 8 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
3.1
(1.4 to 6.7)
4
(1.6 to 10)
3.9
(1.5 to 10)
1.7
(0.7 to 4.2)
1.4
(0.8 to 2.6)
13.4
(3.4 to 51.9)
1.2
(0.8 to 1.8)
3.6
(0.9 to 14.9)
1.2
(0.6 to 2.3)
6.5
(3.4 to 12.2)
0.9
(0.6 to 1.2)
GII.4: II Run:365 Days PD2 Number Analyzed 6 participants 7 participants 8 participants 7 participants 7 participants 8 participants 10 participants 9 participants 9 participants 7 participants 7 participants
2.7
(1 to 7.4)
4.6
(2 to 10.6)
2.4
(0.8 to 7.5)
1.9
(0.6 to 5.9)
1.3
(0.7 to 2.5)
7.7
(2.5 to 23.7)
1.4
(0.8 to 2.5)
2.5
(0.6 to 9.9)
1.9
(0.9 to 4.3)
6
(3.2 to 11.2)
0.9
(0.7 to 1.1)
14.Secondary Outcome
Title GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgM as Compared to Baseline
Hide Description Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time Frame I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected because serum specimens were not tested for specific IgM antibodies to Norovirus GI.1 and GII.4 VLPs as per the change in planned analysis, because this measurement was not informative in a previous study LV01-103 (NCT00973284).
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
Hide Description Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time Frame I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Hide Outcome Measure Data
Hide Analysis Population Description
PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 9 8 10 8 8 8 10 9 9 8 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
GI.1: I Run:7 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 7 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
77.8
(40.0 to 97.2)
100.0
(63.1 to 100.0)
90.0
(55.5 to 99.7)
100.0
(59.0 to 100.0)
0.0
(0.0 to 36.9)
100.0
(63.1 to 100.0)
0.0
(0.0 to 30.8)
88.9
(51.8 to 99.7)
0.0
(0.0 to 33.6)
87.5
(47.3 to 99.7)
0.0
(0.0 to 41.0)
GI.1: I Run:21 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 9 participants 8 participants 8 participants 8 participants 7 participants
88.9
(51.8 to 99.7)
100.0
(63.1 to 100.0)
100.0
(63.1 to 100.0)
100.0
(69.2 to 100.0)
0.0
(0.0 to 36.9)
100.0
(63.1 to 100.0)
0.0
(0.0 to 33.6)
87.5
(47.3 to 99.7)
0.0
(0.0 to 36.9)
75.0
(34.9 to 96.8)
0.0
(0.0 to 41.0)
GI.1: I Run:28 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
77.8
(40.0 to 97.2)
100.0
(63.1 to 100.0)
90.0
(55.5 to 99.7)
87.5
(47.3 to 99.7)
0.0
(0.0 to 36.9)
100.0
(63.1 to 100.0)
0.0
(0.0 to 30.8)
77.8
(40.0 to 97.2)
0.0
(0.0 to 33.6)
62.5
(24.5 to 91.5)
0.0
(0.0 to 41.0)
GI.1: I Run:7 Days PD2 Number Analyzed 9 participants 7 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
77.8
(40.0 to 97.2)
100.0
(59.0 to 100.0)
100.0
(69.2 to 100.0)
100.0
(63.1 to 100.0)
0.0
(0.0 to 36.9)
100.0
(63.1 to 100.0)
0.0
(0.0 to 30.8)
88.9
(51.8 to 99.7)
0.0
(0.0 to 33.6)
62.5
(24.5 to 91.5)
0.0
(0.0 to 41.0)
GI.1: I Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
77.8
(40.0 to 97.2)
100.0
(59.0 to 100.0)
88.9
(51.8 to 99.7)
87.5
(47.3 to 99.7)
0.0
(0.0 to 36.9)
100.0
(63.1 to 100.0)
0.0
(0.0 to 30.8)
88.9
(51.8 to 99.7)
0.0
(0.0 to 33.6)
62.5
(24.5 to 91.5)
0.0
(0.0 to 41.0)
GI.1: II Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
66.7
(29.9 to 92.5)
71.4
(29.0 to 96.3)
55.6
(21.2 to 86.3)
62.5
(24.5 to 91.5)
0.0
(0.0 to 41.0)
100.0
(63.1 to 100.0)
0.0
(0.0 to 30.8)
100.0
(66.4 to 100.0)
0.0
(0.0 to 33.6)
87.5
(47.3 to 99.7)
0.0
(0.0 to 41.0)
GI.1: II Run:152 Days PD2 Number Analyzed 8 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
62.5
(24.5 to 91.5)
42.9
(9.9 to 81.6)
44.4
(13.7 to 78.8)
50.0
(15.7 to 84.3)
0.0
(0.0 to 41.0)
100.0
(63.1 to 100.0)
0.0
(0.0 to 30.8)
66.7
(29.9 to 92.5)
0.0
(0.0 to 33.6)
75.0
(34.9 to 96.8)
0.0
(0.0 to 41.0)
GI.1: II Run:365 Days PD2 Number Analyzed 6 participants 7 participants 8 participants 7 participants 7 participants 8 participants 10 participants 9 participants 9 participants 7 participants 7 participants
50.0
(11.8 to 88.2)
42.9
(9.9 to 81.6)
37.5
(8.5 to 75.5)
57.1
(18.4 to 90.1)
0.0
(0.0 to 41.0)
100.0
(63.1 to 100.0)
0.0
(0.0 to 30.8)
66.7
(29.9 to 92.5)
0.0
(0.0 to 33.6)
71.4
(29.0 to 96.3)
0.0
(0.0 to 41.0)
GII.4: I Run:7 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 7 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
55.6
(21.2 to 86.3)
75.0
(34.9 to 96.8)
70.0
(34.8 to 93.3)
42.9
(9.9 to 81.6)
0.0
(0.0 to 36.9)
62.5
(24.5 to 91.5)
0.0
(0.0 to 30.8)
55.6
(21.2 to 86.3)
0.0
(0.0 to 33.6)
87.5
(47.3 to 99.7)
0.0
(0.0 to 41.0)
GII.4: I Run:21 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 8 participants 8 participants 8 participants 7 participants
55.6
(21.2 to 86.3)
75.0
(34.9 to 96.8)
50.0
(18.7 to 81.3)
25.0
(3.2 to 65.1)
0.0
(0.0 to 36.9)
75.0
(34.9 to 96.8)
0.0
(0.0 to 30.8)
25.0
(3.2 to 65.1)
0.0
(0.0 to 36.9)
75.0
(34.9 to 96.8)
0.0
(0.0 to 41.0)
GII.4: I Run:28 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
55.6
(21.2 to 86.3)
62.5
(24.5 to 91.5)
50.0
(18.7 to 81.3)
12.5
(0.3 to 52.7)
12.5
(0.3 to 52.7)
50.0
(15.7 to 84.3)
0.0
(0.0 to 30.8)
22.2
(2.8 to 60.0)
0.0
(0.0 to 33.6)
75.0
(34.9 to 96.8)
0.0
(0.0 to 41.0)
GII.4: I Run:7 Days PD2 Number Analyzed 9 participants 7 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
44.4
(13.7 to 78.8)
71.4
(29.0 to 96.3)
50.0
(18.7 to 81.3)
25.0
(3.2 to 65.1)
12.5
(0.3 to 52.7)
62.5
(24.5 to 91.5)
0.0
(0.0 to 30.8)
33.3
(7.5 to 70.1)
0.0
(0.0 to 33.6)
62.5
(24.5 to 91.5)
0.0
(0.0 to 41.0)
GII.4: I Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
44.4
(13.7 to 78.8)
57.1
(18.4 to 90.1)
44.4
(13.7 to 78.8)
25.0
(3.2 to 65.1)
12.5
(0.3 to 52.7)
50.0
(15.7 to 84.3)
0.0
(0.0 to 30.8)
22.2
(2.8 to 60.0)
0.0
(0.0 to 33.6)
62.5
(24.5 to 91.5)
0.0
(0.0 to 41.0)
GII.4: II Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
77.8
(40.0 to 97.2)
100.0
(59.0 to 100.0)
55.6
(21.2 to 86.3)
37.5
(8.5 to 75.5)
14.3
(0.4 to 57.9)
50.0
(15.7 to 84.3)
0.0
(0.0 to 30.8)
33.3
(7.5 to 70.1)
0.0
(0.0 to 33.6)
62.5
(24.5 to 91.5)
0.0
(0.0 to 41.0)
GII.4: II Run:152 Days PD2 Number Analyzed 8 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
12.5
(0.3 to 52.7)
42.9
(9.9 to 81.6)
33.3
(7.5 to 70.1)
25.0
(3.2 to 65.1)
14.3
(0.4 to 57.9)
25.0
(3.2 to 65.1)
0.0
(0.0 to 30.8)
33.3
(7.5 to 70.1)
0.0
(0.0 to 33.6)
50.0
(15.7 to 84.3)
0.0
(0.0 to 41.0)
GII.4: II Run:365 Days PD2 Number Analyzed 6 participants 7 participants 8 participants 7 participants 7 participants 8 participants 10 participants 9 participants 9 participants 7 participants 7 participants
0.0
(0.0 to 45.9)
42.6
(9.9 to 81.6)
37.5
(8.5 to 75.5)
14.3
(0.4 to 57.9)
14.3
(0.4 to 57.9)
25.0
(3.2 to 65.1)
10.0
(0.3 to 44.5)
22.2
(2.8 to 60.0)
11.1
(0.3 to 48.2)
57.1
(18.4 to 90.1)
0.0
(0.0 to 41.0)
16.Secondary Outcome
Title Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
Hide Description Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time Frame I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Hide Outcome Measure Data
Hide Analysis Population Description
PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 9 8 10 8 8 8 10 9 9 8 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
GI.1: I Run:7 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 7 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
66.7
(29.9 to 92.5)
100.0
(63.1 to 100.0)
100.0
(69.2 to 100.0)
100.0
(59.0 to 100.0)
0.0
(0.0 to 36.9)
87.5
(47.3 to 99.7)
0.0
(0.0 to 30.8)
55.6
(21.2 to 86.3)
0.0
(0.0 to 33.6)
75.0
(34.9 to 96.8)
0.0
(0.0 to 41.0)
GI.1: I Run:21 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 9 participants 8 participants 8 participants 8 participants 7 participants
77.8
(40.0 to 97.2)
100.0
(63.1 to 100.0)
100.0
(69.2 to 100.0)
100.0
(63.1 to 100.0)
0.0
(0.0 to 36.9)
87.5
(47.3 to 99.7)
0.0
(0.0 to 33.6)
50.0
(15.7 to 84.3)
0.0
(0.0 to 36.9)
75.0
(34.9 to 96.8)
0.0
(0.0 to 41.0)
GI.1: I Run:28 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
77.8
(40.0 to 97.2)
87.5
(47.3 to 99.7)
100.0
(69.2 to 100.0)
100.0
(63.1 to 100.0)
0.0
(0.0 to 36.9)
87.5
(47.3 to 99.7)
0.0
(0.0 to 30.8)
55.6
(21.2 to 86.3)
0.0
(0.0 to 33.6)
75.0
(34.9 to 96.8)
0.0
(0.0 to 41.0)
GI.1: I Run:7 Days PD2 Number Analyzed 9 participants 7 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
77.8
(40.0 to 97.2)
100.0
(59.0 to 100.0)
100.0
(69.2 to 100.0)
100.0
(63.1 to 100.0)
12.5
(0.3 to 52.7)
87.5
(47.3 to 99.7)
0.0
(0.0 to 30.8)
66.7
(29.9 to 92.5)
0.0
(0.0 to 33.6)
75.0
(34.9 to 96.8)
0.0
(0.0 to 41.0)
GI.1: I Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
77.8
(40.0 to 97.2)
100.0
(59.0 to 100.0)
100.0
(66.4 to 100.0)
100.0
(63.1 to 100.0)
12.5
(0.3 to 52.7)
87.5
(47.3 to 99.7)
0.0
(0.0 to 30.8)
77.8
(40.0 to 97.2)
0.0
(0.0 to 33.6)
75.0
(34.9 to 96.8)
0.0
(0.0 to 41.0)
GI.1: II Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
77.8
(40.0 to 97.2)
100.0
(59.0 to 100.0)
88.9
(51.8 to 99.7)
100.0
(63.1 to 100.0)
14.3
(0.4 to 57.9)
100.0
(63.1 to 100.0)
0.0
(0.0 to 30.8)
88.9
(51.8 to 99.7)
0.0
(0.0 to 33.6)
100.0
(63.1 to 100.0)
0.0
(0.0 to 41.0)
GI.1: II Run:152 Days PD2 Number Analyzed 8 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
50.0
(15.7 to 84.3)
85.7
(42.1 to 99.6)
88.9
(51.8 to 99.7)
87.5
(47.3 to 99.7)
14.3
(0.4 to 57.9)
87.5
(47.3 to 99.7)
0.0
(0.0 to 30.8)
88.9
(51.8 to 99.7)
0.0
(0.0 to 33.6)
75.0
(34.9 to 96.8)
0.0
(0.0 to 41.0)
GI.1: II Run:365 Days PD2 Number Analyzed 6 participants 7 participants 8 participants 7 participants 7 participants 8 participants 10 participants 9 participants 9 participants 7 participants 7 participants
50.0
(11.8 to 88.2)
85.7
(42.1 to 99.6)
75.0
(34.9 to 96.8)
85.7
(42.1 to 99.6)
0.0
(0.0 to 41.0)
87.5
(47.3 to 99.7)
0.0
(0.0 to 30.8)
66.7
(29.9 to 92.5)
11.1
(0.3 to 48.2)
71.4
(29.0 to 96.3)
0.0
(0.0 to 41.0)
GII.4: I Run:7 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 7 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
22.2
(2.8 to 60.0)
62.5
(24.5 to 91.5)
80.0
(44.4 to 97.5)
28.6
(3.7 to 871.0)
0.0
(0.0 to 36.9)
62.5
(24.5 to 91.5)
0.0
(0.0 to 30.8)
33.3
(7.5 to 70.1)
0.0
(0.0 to 33.6)
75.0
(34.9 to 96.8)
0.0
(0.0 to 41.0)
GII.4: I Run:21 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 8 participants 8 participants 8 participants 7 participants
33.3
(7.5 to 70.1)
62.5
(24.5 to 91.5)
70.0
(34.8 to 93.3)
12.5
(0.3 to 52.7)
0.0
(0.0 to 36.9)
87.5
(47.3 to 99.7)
0.0
(0.0 to 30.8)
50.0
(15.7 to 84.3)
0.0
(0.0 to 36.9)
87.5
(47.3 to 99.7)
0.0
(0.0 to 41.0)
GII.4: I Run:28 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
33.3
(7.5 to 70.1)
62.5
(24.5 to 91.5)
70.0
(34.8 to 93.3)
12.5
(0.3 to 52.7)
12.5
(0.3 to 52.7)
75.0
(34.9 to 96.8)
0.0
(0.0 to 30.8)
44.4
(13.7 to 878.8)
0.0
(0.0 to 33.6)
87.5
(47.3 to 99.7)
0.0
(0.0 to 41.0)
GII.4: I Run:7 Days PD2 Number Analyzed 9 participants 7 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
44.4
(13.7 to 78.8)
57.1
(18.4 to 90.1)
70.0
(34.8 to 93.3)
25.0
(3.2 to 65.1)
12.5
(0.3 to 52.7)
75.0
(34.9 to 96.8)
0.0
(0.0 to 30.8)
44.4
(13.7 to 78.8)
0.0
(0.0 to 33.6)
87.5
(47.3 to 99.7)
0.0
(0.0 to 41.0)
GII.4: I Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
33.3
(7.5 to 70.1)
57.1
(18.4 to 90.1)
66.7
(29.9 to 92.5)
12.5
(0.3 to 52.7)
12.5
(0.3 to 52.7)
87.5
(47.3 to 99.7)
0.0
(0.0 to 30.8)
44.4
(13.7 to 78.8)
0.0
(0.0 to 33.6)
100.0
(63.1 to 100.0)
0.0
(0.0 to 41.0)
GII.4: II Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
55.6
(21.2 to 86.3)
71.4
(29.0 to 96.3)
77.8
(40.0 to 97.2)
50.0
(15.7 to 84.3)
14.3
(0.4 to 57.9)
75.0
(34.9 to 96.8)
0.0
(0.0 to 30.8)
66.7
(29.9 to 92.5)
0.0
(0.0 to 33.6)
87.5
(47.3 to 99.7)
0.0
(0.0 to 41.0)
GII.4: II Run:152 Days PD2 Number Analyzed 8 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
50.0
(15.7 to 84.3)
42.9
(9.9 to 81.6)
66.7
(29.9 to 92.5)
25.0
(3.5 to 65.1)
14.3
(0.4 to 57.9)
62.5
(24.5 to 91.5)
10.0
(0.3 to 44.5)
66.7
(29.9 to 92.5)
11.1
(0.3 to 48.2)
75.0
(34.9 to 96.8)
0.0
(0.0 to 41.0)
GII.4: II Run:365 Days PD2 Number Analyzed 6 participants 7 participants 8 participants 7 participants 7 participants 8 participants 10 participants 9 participants 9 participants 7 participants 7 participants
33.3
(4.3 to 77.7)
57.1
(18.4 to 90.1)
50.0
(15.7 to 584.3)
28.6
(3.7 to 71.0)
14.3
(0.4 to 57.9)
50.0
(15.7 to 84.3)
10.0
(0.3 to 44.5)
55.6
(21.2 to 86.3)
22.2
(2.8 to 60.0)
85.7
(42.1 to 99.6)
0.0
(0.0 to 41.0)
17.Secondary Outcome
Title Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgM
Hide Description Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time Frame I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected because serum specimens were not tested for specific IgM antibodies to Norovirus GI.1 and GII.4 VLPs as per the change in planned analysis, because this measurement was not informative in a previous study LV01-103 (NCT00973284).
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
Hide Description GMTs were assessed for Anti-norovirus GI.1 and GII.4 VLP by Pan-Ig ELISA. A pan ELISA assay captured IgG, IgA and IgM combined. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time Frame I run: predose 1, 7, 21, 28 days PD1, 7 and 28 days PD2; II run: predose 1, 28, 152 and 365 days PD2 (up to Day 393)
Hide Outcome Measure Data
Hide Analysis Population Description
PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 9 8 10 8 9 8 10 9 9 8 7
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
GI.1: I Run: Pre-Dose 1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
3763
(894 to 15838)
2348
(599 to 9198)
2560
(950 to 6901)
2153
(447 to 10366)
1396
(162 to 12052)
1810
(486 to 6737)
2744
(806 to 9337)
6451
(2020 to 20603)
2763
(668 to 21197)
1280
(320 to 5115)
861
(147 to 5054)
GI.1: I Run:7 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 7 participants 9 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
163840
(77123 to 348063)
231705
(135499 to 396217)
351199
(159240 to 774559)
220512
(57489 to 831259)
1185
(179 to 7861)
150242
(52704 to 428288)
2229
(596 to 8327)
151695
(57115 to 402894)
3763
(668 to 21197)
126338
(39749 to 401554)
861
(153 to 4860)
GI.1: I Run:21 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 7 participants
260080
(122425 to 552516)
194840
(92705 to 409496)
285262
(127800 to 636731)
212474
(93970 to 480425)
1185
(193 to 7282)
212474
(114914 to 392862)
2389
(658 to 8676)
115852
(51050 to 262916)
7241
(2719 to 19283)
137772
(58166 to 326329)
861
(207 to 3587)
GI.1: I Run:28 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 9 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
222952
(109569 to 453664)
126338
(59394 to 268734)
216188
(102476 to 456081)
194840
(106949 to 354959)
1280
(219 to 7493)
212474
(106756 to 422883)
2389
(658 to 8676)
120401
(56380 to 257117)
3763
(696 to 20334)
106230
(42084 to 268187)
707
(122 to 4078)
GI.1: I Run:7 Days PD2 Number Analyzed 9 participants 7 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
176957
(85545 to 366049)
163840
(86301 to 311047)
266159
(143088 to 495085)
212474
(124953 to 361298)
1974
(396 to 9852)
231705
(169986 to 315832)
2229
(584 to 8500)
176957
(116676 to 268383)
4389
(872 to 22081)
126338
(68328 to 233597)
861
(207 to 3587)
GI.1: I Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
206425
(102014 to 417702)
148394
(83353 to 264185)
176957
(81595 to 383771)
150242
(92634 to 243676)
1974
(352 to 11056)
300484
(156475 to 577028)
2079
(532 to 8134)
176957
(128475 to 243735)
5120
(1388 to 18883)
89334
(61622 to 129510)
861
(180 to 4116)
GI.1: II Run:Pre-Dose 1 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
4389
(978 to 19405)
3121
(657 to 14817)
3484
(870 to 13946)
1974
(408 to 9540)
3121
(415 to 23466)
2560
(803 to 8158)
2941
(804 to 10760)
4389
(156 to 12222)
2560
(567 to 11554)
587
(155 to 2219)
390
(82 to 1852)
GI.1: II Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
260080
(112007 to 603906)
243465
(117694 to 503640)
222952
(91740 to 541832)
212474
(124953 to 361298)
3446
(506 to 23456)
357338
(246486 to 518042)
2744
(696 to 10819)
140451
(98461 to 200348)
2195
(392 to 12279)
89334
(61622 to 129510)
353
(53 to 2369)
GI.1: II Run:152 Days PD2 Number Analyzed 8 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
97420
(41130 to 230749)
121733
(53847 to 275205)
95562
(43402 to 210408)
126338
(93602 to 170523)
3121
(478 to 20386)
150242
(103635 to 217810)
2941
(756 to 11445)
81920
(56204 to 119401)
2370
(409 to 13721)
31584
(20522 to 48609)
390
(75 to 2018)
GI.1: II Run:365 Days PD2 Number Analyzed 6 participants 7 participants 8 participants 7 participants 8 participants 8 participants 10 participants 9 participants 9 participants 7 participants 7 participants
145965
(62364 to 341636)
67202
(25756 to 175341)
63169
(21663 to 184198)
81920
(48537 to 138264)
2153
(409 to 11331)
75121
(51817 to 108905)
2941
(699 to 12376)
47781
(30650 to 74487)
3484
(560 to 21684)
18549
(10419 to 33023)
353
(64 to 1960)
GII.4: I Run: Pre-Dose 1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
11945
(3089 to 46196)
3948
(1103 to 14126)
1470
(287 to 7526)
28963
(5792 to 144824)
5583
(1425 to 21877)
4695
(804 to 27403)
2229
(408 to 12181)
9481
(1706 to 52683)
8127
(1540 to 42902)
6089
(2015 to 18402)
9275
(2069 to 41572)
GII.4: I Run:7 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 7 participants 9 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
55738
(32476 to 95661)
53119
(23492 to 120106)
71316
(35649 to 142667)
593575
(250592 to 1405995)
4740
(1381 to 16278)
115852
(45745 to 293407)
1940
(377 to 9997)
88478
(42773 to 183024)
6451
(1429 to 29113)
300484
(110464 to 817377)
7608
(1665 to 34773)
GII.4: I Run:21 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 7 participants
70225
(39229 to 125714)
44667
(20355 to 98017)
50428
(24962 to 101872)
505352
(297190 to 859315)
5120
(1603 to 16352)
163840
(81963 to 327507)
1810
(329 to 9966)
126338
(55875 to 285662)
9390
(1854 to 47567)
212474
(114914 to 392862)
8400
(1694 to 41653)
GII.4: I Run:28 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 9 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
70225
(33407 to 147623)
40960
(19180 to 87472)
38217
(17951 to 81361)
275545
(151249 to 501988)
6451
(2151 to 19348)
150242
(84602 to 266810)
2079
(426 to 10158)
111476
(52201 to 238058)
7525
(1588 to 35664)
126338
(74298 to 214829)
7608
(1665 to 34773)
GII.4: I Run:7 Days PD2 Number Analyzed 9 participants 7 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
75848
(40737 to 141221)
60866
(36756 to 100792)
43900
(24247 to 79483)
300484
(185267 to 487353)
10240
(3502 to 29943)
163840
(88181 to 304413)
1810
(329 to 9966)
130040
(67714 to 249731)
8127
(1573 to 41991)
178669
(100609 to 317292)
10240
(2130 to 49233)
GII.4: I Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
75848
(34973 to 164493)
60866
(36756 to 100792)
47781
(25186 to 90647)
212474
(106756 to 422883)
11167
(3442 to 36230)
126338
(68328 to 233597)
1810
(363 to 9026)
103213
(46414 to 229521)
6967
(1405 to 34539)
115852
(57957 to 231582)
10240
(2330 to 45004)
GII.4: II Run:Pre-Dose 1 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
13934
(3481 to 55783)
10240
(2841 to 36907)
4389
(1026 to 18781)
18780
(3498 to 100825)
4200
(968 to 18216)
3948
(544 to 28648)
2560
(606 to 10815)
7525
(1257 to 45038)
6967
(1540 to 31526)
5120
(2022 to 12967)
5653
(1106 to 28892)
GII.4: II Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
88478
(44992 to 173997)
90447
(38184 to 214241)
103213
(65064 to 163729)
126338
(63477 to 251448)
8400
(1240 to 56896)
150242
(78238 to 288514)
2560
(727 to 9014)
65020
(32132 to 131568)
6967
(1577 to 30788)
115852
(62354 to 215253)
6241
(1439 to 27068)
GII.4: II Run:152 Days PD2 Number Analyzed 8 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
81920
(34112 to 196732)
49931
(24467 to 101894)
27869
(15260 to 50896)
63169
(34164 to 116798)
6241
(1158 to 33639)
150242
(48269 to 467639)
2744
(740 to 10177)
35113
(14643 to 84196)
8778
(2002 to 38482)
48710
(23176 to 102374)
5653
(1321 to 24190)
GII.4: II Run:365 Days PD2 Number Analyzed 6 participants 7 participants 8 participants 7 participants 8 participants 8 participants 10 participants 9 participants 9 participants 7 participants 7 participants
45976
(13134 to 160938)
49931
(19137 to 130278)
20480
(11977 to 35021)
67202
(25756 to 175341)
3948
(957 to 16290)
57926
(33875 to 99054)
3378
(690 to 16544)
27869
(11467 to 67729)
12902
(3151 to 52826)
37098
(17025 to 80838)
5653
(1321 to 24190)
19.Secondary Outcome
Title GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
Hide Description GMFRs in GMTs of Anti-norovirus GI.1 and GII.4 VLP by Pan-Ig ELISA. A pan ELISA assay captured IgG, IgA and IgM combined. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time Frame I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Hide Outcome Measure Data
Hide Analysis Population Description
PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
Arm/Group Title Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Cohort A1-A4: Placebo Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort B: Placebo Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Cohort C: Placebo Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Cohort D: Placebo
Hide Arm/Group Description:
Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years.
Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years.
Overall Number of Participants Analyzed 9 8 10 8 8 8 10 9 9 8 7
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold rise
GI.1: I Run:7 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 7 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
43.5
(9.9 to 192.4)
98.7
(21.7 to 449.2)
137.2
(50.3 to 374.4)
128
(61.1 to 268.3)
1 [1] 
(NA to NA)
83
(9.7 to 708.7)
0.8
(0.6 to 1)
23.5
(5.5 to 101.4)
1 [1] 
(NA to NA)
98.7
(28.7 to 339.9)
1
(0.7 to 1.4)
GI.1: I Run:21 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 8 participants 8 participants 8 participants 7 participants
69.1
(15.9 to 300.6)
83
(17.7 to 389.8)
111.4
(51.7 to 240.2)
98.7
(41.2 to 236.2)
1.1
(0.8 to 1.6)
117.4
(23.2 to 594.6)
0.9
(0.7 to 1.1)
20.7
(4.2 to 103.6)
1 [1] 
(NA to NA)
107.6
(23.8 to 487)
1
(0.6 to 1.7)
GI.1: I Run:28 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
59.3
(12.4 to 283)
53.8
(11.5 to 251.3)
84.4
(49.6 to 143.9)
90.5
(31 to 264.7)
1.2
(0.8 to 1.8)
117.4
(19.1 to 722.8)
0.9
(0.7 to 1.1)
18.7
(5.7 to 61)
1
(0.8 to 1.3)
83
(18.2 to 377.8)
0.8
(0.6 to 1.1)
GI.1: I Run:7 Days PD2 Number Analyzed 9 participants 7 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
47
(8.9 to 248.9)
78
(15.1 to 403.5)
104
(58.5 to 184.8)
98.7
(31.1 to 313.7)
1.4
(0.6 to 3.2)
128
(29 to 565.4)
0.8
(0.6 to 1)
27.4
(8.9 to 84.3)
1.2
(0.9 to 1.5)
98.7
(28.7 to 339.9)
1
(0.6 to 1.7)
GI.1: I Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
54.9
(10.2 to 294.4)
70.7
(16.5 to 302.4)
64
(37.6 to 109)
69.8
(20.7 to 235.7)
1.4
(0.6 to 3.2)
166
(35.3 to 779.6)
0.8
(0.5 to 1.1)
27.4
(9.9 to 76.4)
1.4
(0.7 to 2.5)
69.8
(19.9 to 245)
1
(0.7 to 1.4)
GI.1: II Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
59.3
(13 to 270.2)
78
(16.4 to 370.4)
64
(31.6 to 129.5)
107.6
(34.1 to 339.4)
1.1
(0.6 to 2)
139.6
(46.8 to 416.2)
0.9
(0.6 to 1.3)
32
(12.2 to 83.6)
0.9
(0.7 to 1.1)
152.2
(41.3 to 561.3)
0.9
(0.6 to 1.4)
GI.1: II Run:152 Days PD2 Number Analyzed 8 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
17.4
(4.3 to 70.8)
39
(7.9 to 193.4)
27.4
(11.9 to 63.1)
64
(15 to 273.6)
1
(0.7 to 1.4)
58.7
(21.6 to 159.6)
1
(0.7 to 1.5)
18.7
(8.5 to 41.1)
0.9
(0.7 to 1.3)
53.8
(15.7 to 184)
1
(0.7 to 1.4)
GI.1: II Run:365 Days PD2 Number Analyzed 6 participants 7 participants 8 participants 7 participants 7 participants 8 participants 10 participants 9 participants 9 participants 7 participants 7 participants
25.4
(2.1 to 311.2)
21.5
(4.7 to 98.4)
19
(8.5 to 42.5)
58
(16.6 to 202.6)
1
(0.6 to 1.7)
29.3
(10.8 to 79.8)
1
(0.7 to 1.5)
10.9
(3.7 to 31.7)
1.4
(0.7 to 2.5)
43.1
(19.7 to 97.4)
0.9
(0.6 to 1.4)
GII.4: I Run:7 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 7 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
4.7
(1.5 to 14.3)
13.5
(3 to 60.9)
48.5
(7.9 to 297.4)
19.5
(1.8 to 213)
1 [1] 
(NA to NA)
24.7
(4.7 to 130.6)
0.9
(0.6 to 1.2)
9.3
(2.2 to 39.9)
0.8
(0.6 to 1)
49.4
(9.6 to 253.7)
0.8
(0.6 to 1.1)
GII.4: I Run:21 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 8 participants 8 participants 8 participants 7 participants
5.9
(1.5 to 23.5)
11.3
(3.6 to 36.1)
34.3
(7.3 to 160.1)
17.4
(3.2 to 96.4)
1.1
(0.8 to 1.6)
34.9
(7.1 to 171.6)
0.8
(0.6 to 1.1)
19
(5.4 to 67.6)
0.8
(0.6 to 1.1)
34.9
(7.5 to 131.4)
0.9
(0.6 to 1.4)
GII.4: I Run:28 Days PD1 Number Analyzed 9 participants 8 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
5.9
(1.5 to 22.3)
10.4
(3.6 to 30.3)
26
(5.1 to 131.4)
9.5
(1.8 to 50.1)
1.4
(0.8 to 2.6)
32
(7.7 to 132.3)
0.9
(0.7 to 1.2)
11.8
(3 to 45.9)
0.9
(0.8 to 1.1)
20.7
(5.2 to 82.7)
0.8
(0.6 to 1.1)
GII.4: I Run:7 Days PD2 Number Analyzed 9 participants 7 participants 10 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
6.3
(2 to 20.3)
10.8
(2.9 to 40.6)
29.9
(6.1 to 146.9)
10.4
(2.1 to 50.2)
1.8
(0.5 to 6.2)
34.9
(6.3 to 192.7)
0.8
(0.6 to 1.1)
13.7
(3.1 to 60.1)
1
(0.8 to 1.3)
29.3
(8.4 to 103)
1.1
(0.7 to 1.7)
GII.4: I Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 8 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
6.3
(1.7 to 24.1)
10.8
(3.4 to 34.4)
21.8
(6.6 to 71.9)
7.3
(1.5 to 35)
2
(0.5 to 8.3)
26.9
(5.4 to 133.6)
0.8
(0.6 to 1.1)
10.9
(2.5 to 48.1)
0.9
(0.7 to 1.1)
19
(5.4 to 67.6)
1.1
(0.7 to 1.7)
GII.4: II Run:28 Days PD2 Number Analyzed 9 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
6.3
(1.6 to 24.7)
8.8
(2.5 to 30.9)
23.5
(6.5 to 84.6)
6.7
(1.5 to 29.5)
2
(0.5 to 8.4)
38.1
(6 to 242.5)
1
(0.8 to 1.3)
8.6
(1.9 to 40.3)
1
(0.8 to 1.3)
22.6
(8.5 to 60.3)
1.1
(0.9 to 1.4)
GII.4: II Run:152 Days PD2 Number Analyzed 8 participants 7 participants 9 participants 8 participants 7 participants 8 participants 10 participants 9 participants 9 participants 8 participants 7 participants
3.7
(1.5 to 9)
4.9
(1.4 to 17.3)
6.3
(1.9 to 21.5)
3.4
(0.8 to 13.3)
1.5
(0.5 to 4.2)
38.1
(7 to 206.1)
1.1
(0.7 to 1.7)
4.7
(0.9 to 23)
1.3
(0.5 to 3.4)
9.5
(3.8 to 23.8)
1
(0.7 to 1.4)
GII.4: II Run:365 Days PD2 Number Analyzed 6 participants 7 participants 8 participants 7 participants 7 participants 8 participants 10 participants 9 participants 9 participants 7 participants 7 participants
4
(0.7 to 23.8)
4.9
(1.2 to 19.2)
3.4
(0.8 to 13.3)
3.3
(0.6 to 17)
1.2
(0.5 to 2.7)
14.7
(2.2 to 100.1)
1.3
(0.6 to 2.8)
3.7
(0.9 to 16.1)
1.9
(0.8 to 4.4)
8.8
(4.1 to 19.2)
1
(0.7 to 1.4)
[1]
Confidence interval could not be calculated because there was no variance in the observed data.
20.Secondary Outcome
Title Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
Hide Description Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time Frame I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II r