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Trial record 55 of 141 for:    MPL

Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine (NOR-107)

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: NCT02038907
Recruitment Status : Completed
First Posted : January 17, 2014
Results First Posted : August 1, 2016
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Healthy Volunteers
Norovirus, Prevention
Interventions Biological: Hepatitis A Vaccine
Biological: Norovirus Bivalent VLP Vaccine
Enrollment 420
Recruitment Details Participants took part in the study at 2 investigative sites in Belgium from 28 March 2014 (first participants signed the informed consent form) to 19 June 2015.
Pre-assignment Details Healthy volunteers were enrolled equally in 1 of 14 unique formulation treatment groups: 11 formulation arms received 1 dose and 3 formulation arms received 2 doses.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28. Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28. Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28. Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Period Title: Overall Study
Started 30 30 30 31 30 31 30 32 29 30 29 28 29 31
Completed 30 30 30 31 30 31 30 32 29 30 27 28 29 31
Not Completed 0 0 0 0 0 0 0 0 0 0 2 0 0 0
Reason Not Completed
Protocol Violation             0             0             0             0             0             0             0             0             0             0             1             0             0             0
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             1             0             0             0
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2 Total
Hide Arm/Group Description Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28. Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28. Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28. Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28. Total of all reporting groups
Overall Number of Baseline Participants 30 30 30 31 30 31 30 32 29 30 29 28 29 31 420
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 30 participants 31 participants 30 participants 31 participants 30 participants 32 participants 29 participants 30 participants 29 participants 28 participants 29 participants 31 participants 420 participants
50.0
(19 to 63)
51.0
(20 to 64)
50.0
(22 to 64)
50.0
(20 to 64)
49.5
(20 to 64)
50.0
(20 to 64)
49.5
(18 to 64)
48.5
(18 to 63)
41.0
(21 to 63)
51.0
(20 to 63)
49.0
(21 to 62)
48.5
(23 to 64)
48.0
(22 to 63)
44.0
(19 to 64)
49.5
(18 to 64)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 30 participants 31 participants 30 participants 31 participants 30 participants 32 participants 29 participants 30 participants 29 participants 28 participants 29 participants 31 participants 420 participants
18-49 Years 15 14 15 15 15 15 15 16 15 15 15 14 15 16 210
50-64 Years 15 16 15 16 15 16 15 16 14 15 14 14 14 15 210
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 30 participants 31 participants 30 participants 31 participants 30 participants 32 participants 29 participants 30 participants 29 participants 28 participants 29 participants 31 participants 420 participants
Female
18
  60.0%
20
  66.7%
20
  66.7%
22
  71.0%
19
  63.3%
23
  74.2%
15
  50.0%
18
  56.3%
20
  69.0%
23
  76.7%
16
  55.2%
16
  57.1%
20
  69.0%
18
  58.1%
268
  63.8%
Male
12
  40.0%
10
  33.3%
10
  33.3%
9
  29.0%
11
  36.7%
8
  25.8%
15
  50.0%
14
  43.8%
9
  31.0%
7
  23.3%
13
  44.8%
12
  42.9%
9
  31.0%
13
  41.9%
152
  36.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 30 participants 31 participants 30 participants 31 participants 30 participants 32 participants 29 participants 30 participants 29 participants 28 participants 29 participants 31 participants 420 participants
American Indian or Alaska Native 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1
Asian 1 0 0 1 0 1 0 0 1 1 0 0 0 0 5
White 29 30 30 30 30 29 30 32 28 29 29 28 29 31 414
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Belgium Number Analyzed 30 participants 30 participants 30 participants 31 participants 30 participants 31 participants 30 participants 32 participants 29 participants 30 participants 29 participants 28 participants 29 participants 31 participants 420 participants
30 30 30 31 30 31 30 32 29 30 29 28 29 31 420
Height  
Median (Full Range)
Unit of measure:  Cm
Number Analyzed 30 participants 30 participants 30 participants 31 participants 30 participants 31 participants 30 participants 32 participants 29 participants 30 participants 29 participants 28 participants 29 participants 31 participants 420 participants
173.0
(156 to 187)
167.0
(154 to 193)
166.5
(153 to 191)
167.0
(149 to 187)
171.0
(155 to 186)
169.0
(153 to 190)
173.5
(154 to 189)
169.5
(161 to 192)
171.0
(153 to 193)
167.0
(153 to 186)
172.0
(156 to 199)
171.5
(161 to 192)
170.0
(153 to 187)
175.0
(146 to 192)
170.0
(146 to 199)
Weight  
Median (Full Range)
Unit of measure:  Kg
Number Analyzed 30 participants 30 participants 30 participants 31 participants 30 participants 31 participants 30 participants 32 participants 29 participants 30 participants 29 participants 28 participants 29 participants 31 participants 420 participants
69.50
(49.4 to 105.2)
65.60
(49.1 to 103.0)
70.60
(50.8 to 104.0)
66.60
(42.2 to 103.3)
71.60
(47.6 to 101.9)
68.50
(44.0 to 96.0)
72.50
(45.8 to 104.5)
74.35
(52.0 to 110.3)
76.00
(54.8 to 101.2)
69.85
(50.5 to 92.6)
70.00
(49.6 to 94.0)
75.50
(42.5 to 92.5)
70.60
(49.2 to 111.8)
69.90
(51.0 to 111.3)
70.8
(42.2 to 111.8)
Body Mass Index (BMI)  
Median (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 30 participants 30 participants 30 participants 31 participants 30 participants 31 participants 30 participants 32 participants 29 participants 30 participants 29 participants 28 participants 29 participants 31 participants 420 participants
25.22
(16.7 to 33.6)
23.97
(18.9 to 34.2)
26.11
(17.3 to 33.4)
23.62
(18.7 to 33.7)
24.51
(18.6 to 34.2)
24.73
(17.6 to 34.4)
24.40
(18.1 to 33.7)
24.06
(17.8 to 33.2)
26.06
(19.0 to 34.6)
25.02
(20.0 to 34.4)
23.66
(18.1 to 32.3)
24.24
(14.9 to 32.7)
23.19
(18.7 to 33.8)
24.54
(17.9 to 33.5)
24.52
(14.9 to 34.6)
1.Primary Outcome
Title Percentage of Participants With a Seroresponse (Pan-Ig ELISA)
Hide Description Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).
Time Frame Baseline and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least one dose of trial vaccine.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 29 28 31 30 31 30 32 28 30 26 28 29 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
43.3
(25.5 to 62.6)
62.1
(42.3 to 79.3)
46.4
(27.5 to 66.1)
35.5
(19.2 to 54.6)
80.0
(61.4 to 92.3)
67.7
(48.6 to 83.3)
30.0
(14.7 to 49.4)
62.5
(43.7 to 78.9)
42.9
(24.5 to 62.8)
66.7
(47.2 to 82.7)
46.2
(26.6 to 66.6)
71.4
(51.3 to 86.8)
69.0
(49.2 to 84.7)
56.7
(37.4 to 74.5)
2.Primary Outcome
Title Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1
Hide Description Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.
Time Frame Days 1 through 7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of trial vaccine.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 31 30 31 30 32 29 30 29 28 29 31
Measure Type: Number
Unit of Measure: percentage of participants
Pain 43.3 33.3 50.0 32.3 46.7 38.7 40.0 53.1 44.8 53.3 48.3 46.4 31.0 32.3
Erythema 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Induration 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Swelling 0 0 0 0 0 0 0 0 3.4 0 0 0 0 0
3.Primary Outcome
Title Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2
Hide Description Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.
Time Frame Days 28 through 34
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of trial vaccine.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 31 30 31 30 32 29 30 29 28 29 31
Measure Type: Number
Unit of Measure: percentage of participants
Pain 60.0 36.7 66.7 51.6 53.3 58.1 33.3 43.8 48.3 46.7 34.5 32.1 41.4 35.5
Erythema 0 0 3.3 0 0 0 0 0 3.4 3.3 0 0 0 0
Induration 0 0 3.3 0 6.7 0 0 0 3.4 3.3 0 0 0 0
Swelling 0 3.3 0 3.2 0 3.2 0 0 6.9 0 0 0 0 0
4.Primary Outcome
Title Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1
Hide Description Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.
Time Frame Days 1 through 7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of trial vaccine.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 31 30 31 30 32 29 30 29 28 29 31
Measure Type: Number
Unit of Measure: percentage of participants
Headache 20.0 26.7 3.3 19.4 16.7 12.9 13.3 25.0 27.6 20.0 13.8 17.9 31.0 19.4
Fatigue 23.3 23.3 16.7 19.4 10.0 12.9 13.3 15.6 17.2 20.0 24.1 25.0 17.2 22.6
Myalgia 20.0 6.7 13.3 6.5 3.3 9.7 6.7 18.8 10.3 10.0 17.2 10.7 3.4 19.4
Arthralgia 0 3.3 6.7 0 3.3 0 3.3 6.3 6.9 3.3 3.4 3.6 3.4 3.2
Vomiting 0 3.3 0 0 0 3.2 0 0 0 3.3 3.4 0 0 0
Diarrhea 0 23.3 3.3 16.1 20.0 6.5 13.3 12.5 13.8 10.0 6.9 7.1 10.3 12.9
5.Primary Outcome
Title Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2
Hide Description Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.
Time Frame Days 28 through 34
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of trial vaccine.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 31 30 31 30 32 29 30 29 28 29 31
Measure Type: Number
Unit of Measure: percentage of participants
Headache 13.3 13.3 13.3 22.6 23.3 16.1 10.0 21.9 20.7 10.0 13.8 14.3 34.5 19.4
Fatigue 16.7 13.3 20.0 12.9 10.0 12.9 10.0 18.8 17.2 13.3 13.8 7.1 13.8 12.9
Myalgia 13.3 3.3 13.3 0 13.3 12.9 0 6.3 6.9 0 10.3 7.1 0 6.5
Arthralgia 0 3.3 3.3 0 3.3 3.2 0 3.1 0 3.3 3.4 3.6 0 3.2
Vomiting 0 0 0 0 0 0 0 0 0 3.3 3.4 0 0 0
Diarrhea 3.3 10.0 16.7 12.9 16.7 9.7 6.7 15.6 17.2 10.0 3.4 7.1 6.9 3.2
6.Primary Outcome
Title Oral Body Temperature Within 7 Days After Dose 1
Hide Description Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site.
Time Frame Days 1 through 7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of trial vaccine.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 30 30 31 30 32 29 30 29 28 29 31
Mean (Standard Deviation)
Unit of Measure: degrees Celsius
36.54  (0.294) 36.76  (0.376) 36.66  (0.345) 36.71  (0.260) 36.65  (0.388) 36.67  (0.255) 36.74  (0.323) 36.63  (0.366) 36.52  (0.405) 36.77  (0.341) 36.71  (0.404) 36.61  (0.368) 36.70  (0.362) 36.61  (0.381)
7.Primary Outcome
Title Oral Body Temperature Within 7 Days After Dose 2
Hide Description Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site.
Time Frame Days 28 through 34
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of trial vaccine.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 31 30 31 30 32 29 30 27 28 29 31
Mean (Standard Deviation)
Unit of Measure: degrees Celsius
36.54  (0.282) 36.76  (0.301) 36.68  (0.351) 36.75  (0.466) 36.60  (0.286) 36.72  (0.317) 36.71  (0.394) 36.64  (0.342) 36.59  (0.463) 36.73  (0.293) 36.68  (0.345) 36.56  (0.351) 36.76  (0.391) 36.61  (0.386)
8.Primary Outcome
Title Percentage of Participants With Unsolicited Adverse Events (AEs)
Hide Description Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.
Time Frame Day 1 up to Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of trial vaccine.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 31 30 31 30 32 29 30 29 28 29 31
Measure Type: Number
Unit of Measure: percentage of participants
56.7 60.0 53.3 45.2 43.3 54.8 43.3 62.5 69.0 43.3 48.3 50.0 51.7 61.3
9.Primary Outcome
Title Percentage of Participants With Serious Adverse Events (SAEs)
Hide Description A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Time Frame Day 1 up to Day 393
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of trial vaccine.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 31 30 31 30 32 29 30 29 28 29 31
Measure Type: Number
Unit of Measure: percentage of participants
6.7 0 16.7 6.5 3.3 0 10.0 9.4 3.4 3.3 3.4 7.1 3.4 3.2
10.Secondary Outcome
Title Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)
Hide Description

Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).

D=Day

Time Frame Baseline and Days 28, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 31 30 31 30 32 29 30 29 28 29 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)
0
(0.0 to 11.6)
0
(0.0 to 11.6)
0
(0.0 to 11.9)
0
(0.0 to 11.2)
0
(0.0 to 11.6)
0
(0.0 to 11.2)
0
(0.0 to 11.6)
0
(0.0 to 10.9)
0
(0.0 to 12.3)
0
(0.0 to 11.6)
0
(0.0 to 12.8)
71.4
(51.3 to 86.8)
79.3
(60.3 to 92.0)
67.7
(48.6 to 83.3)
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)
10.0
(2.1 to 26.5)
17.2
(5.8 to 35.8)
10.0
(2.1 to 26.5)
19.4
(7.5 to 37.5)
20.0
(7.7 to 38.6)
20.0
(7.7 to 38.6)
6.7
(0.8 to 22.1)
34.4
(18.6 to 53.2)
17.2
(5.8 to 35.8)
23.3
(9.9 to 42.3)
14.8
(4.2 to 33.7)
32.1
(15.9 to 52.4)
34.5
(17.9 to 54.3)
35.7
(18.6 to 55.9)
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)
17.2
(5.8 to 35.8)
20.7
(8.0 to 39.7)
13.3
(3.8 to 30.7)
16.1
(5.5 to 33.7)
10.0
(2.1 to 26.5)
13.8
(3.9 to 31.7)
10.3
(2.2 to 27.4)
15.6
(5.3 to 32.8)
6.9
(0.8 to 22.8)
13.3
(3.8 to 30.7)
7.4
(0.9 to 24.3)
21.4
(8.3 to 41.0)
20.7
(8.0 to 39.7)
20.7
(8.0 to 39.7)
11.Secondary Outcome
Title Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)
Hide Description

The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).

D=Day

Time Frame Baseline and Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 29 28 29 30 31 30 32 28 30 24 28 29 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
0
(0.0 to 11.6)
0
(0.0 to 11.9)
0
(0.0 to 12.8)
6.9
(0.8 to 22.8)
0
(0.0 to 11.6)
0
(0.0 to 11.2)
0
(0.0 to 11.6)
0
(0.0 to 10.9)
0
(0.0 to 12.8)
0
(0.0 to 11.6)
4.2
(0.1 to 21.1)
85.7
(67.3 to 96.0)
93.1
(77.2 to 99.2)
93.3
(77.9 to 99.2)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
80.0
(61.4 to 92.3)
89.7
(72.6 to 97.8)
100.0
(87.7 to 100.0)
89.7
(72.6 to 97.8)
93.3
(77.9 to 99.2)
96.8
(83.3 to 99.9)
86.7
(69.3 to 96.2)
87.5
(71.0 to 96.5)
92.9
(76.5 to 99.1)
90.0
(73.5 to 97.9)
83.3
(62.6 to 95.3)
85.7
(67.3 to 96.0)
96.6
(82.2 to 99.9)
86.7
(69.3 to 96.2)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)
60.0
(40.6 to 77.3)
65.5
(45.7 to 82.1)
67.9
(47.6 to 84.1)
72.4
(52.8 to 87.3)
70.0
(50.6 to 85.3)
73.3
(54.1 to 87.7)
66.7
(47.2 to 82.7)
62.5
(43.7 to 78.9)
85.7
(67.3 to 96.0)
60.0
(40.6 to 77.3)
54.2
(32.8 to 74.4)
71.4
(51.3 to 86.8)
75.9
(56.5 to 89.7)
74.1
(53.7 to 88.9)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)
55.2
(35.7 to 73.6)
46.4
(27.5 to 66.1)
67.9
(47.6 to 84.1)
69.0
(49.2 to 84.7)
63.3
(43.9 to 80.1)
65.5
(45.7 to 82.1)
55.2
(35.7 to 73.6)
53.1
(34.7 to 70.9)
82.1
(63.1 to 93.9)
43.3
(25.5 to 62.6)
45.8
(25.6 to 67.2)
64.3
(44.1 to 81.4)
72.4
(52.8 to 87.3)
78.6
(59.0 to 91.7)
12.Secondary Outcome
Title Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)
Hide Description

The percentage of participants with a 4-fold rise or greater from in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).

D=Day

Time Frame Baseline and Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 29 28 29 30 31 30 32 28 30 24 28 29 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
0
(0.0 to 11.6)
0
(0.0 to 11.9)
0
(0.0 to 12.8)
0
(0.0 to 11.9)
0
(0.0 to 11.6)
0
(0.0 to 11.2)
3.3
(0.1 to 17.2)
3.1
(0.1 to 16.2)
0
(0.0 to 12.8)
3.3
(0.1 to 17.2)
0
(0.0 to 14.2)
78.6
(59.0 to 91.7)
86.2
(68.3 to 96.1)
70.0
(50.6 to 85.3)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
50.0
(31.3 to 68.7)
65.5
(45.7 to 82.1)
46.4
(27.5 to 66.1)
41.4
(23.5 to 61.1)
83.3
(65.3 to 94.4)
71.0
(52.0 to 85.8)
33.3
(17.3 to 52.8)
71.9
(53.3 to 86.3)
42.9
(24.5 to 62.8)
73.3
(54.1 to 87.7)
54.2
(32.8 to 74.4)
78.6
(59.0 to 91.7)
72.4
(52.8 to 87.3)
63.3
(43.9 to 80.1)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)
16.7
(5.6 to 34.7)
27.6
(12.7 to 47.2)
7.1
(0.9 to 23.5)
27.6
(12.7 to 47.2)
36.7
(19.9 to 56.1)
23.3
(9.9 to 42.3)
16.7
(5.6 to 34.7)
46.9
(29.1 to 65.3)
14.3
(4.0 to 32.7)
30.0
(14.7 to 49.4)
16.7
(4.7 to 37.4)
35.7
(18.6 to 55.9)
41.4
(23.5 to 61.1)
33.3
(16.5 to 54.0)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)
20.7
(8.0 to 39.7)
32.1
(15.9 to 52.4)
10.7
(2.3 to 28.2)
27.6
(12.7 to 47.2)
20.0
(7.7 to 38.6)
17.2
(5.8 to 35.8)
17.2
(5.8 to 35.8)
21.9
(9.3 to 40.0)
10.7
(2.3 to 28.2)
13.3
(3.8 to 30.7)
8.3
(1.0 to 27.0)
28.6
(13.2 to 48.7)
27.6
(12.7 to 47.2)
21.4
(8.3 to 41.0)
13.Secondary Outcome
Title Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Hide Description

Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA.

D=Day

Time Frame Day 1 (Baseline) and Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 31 30 31 30 32 29 30 29 28 29 31
Geometric Mean (Standard Deviation)
Unit of Measure: titer
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31) 833.4  (4.64) 790.3  (4.50) 636.7  (4.60) 647.6  (5.17) 625.3  (2.96) 520.3  (4.99) 890.5  (4.75) 842.9  (4.92) 677.2  (3.75) 827.3  (4.82) 856.7  (5.34) 741.5  (5.28) 897.5  (3.74) 742.7  (3.69)
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31) 798.9  (4.66) 737.9  (4.42) 548.5  (4.47) 806.6  (5.36) 573.6  (3.08) 514.6  (5.19) 910.4  (4.37) 821.5  (4.84) 638.5  (3.90) 780.6  (5.11) 889.7  (5.34) 14488.6  (3.00) 20839.2  (1.96) 15967.7  (2.39)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30) 14417.7  (2.74) 14171.3  (2.76) 17504.8  (2.64) 14220.4  (3.23) 13982.2  (2.33) 18266.0  (1.99) 16082.5  (2.07) 15974.2  (3.95) 25808.9  (2.55) 15466.3  (2.59) 14045.2  (2.94) 12613.2  (2.46) 17696.3  (1.92) 12235.7  (2.11)
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29) 5725.2  (2.37) 5069.7  (2.48) 6084.3  (2.43) 5613.9  (2.68) 4467.6  (2.05) 5106.4  (2.06) 5660.5  (2.22) 7174.8  (2.47) 7542.0  (2.28) 5361.1  (2.37) 5162.8  (2.18) 6863.9  (2.27) 7459.1  (1.72) 5912.6  (1.94)
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29) 3886.0  (2.98) 3179.7  (2.78) 4470.4  (2.55) 5009.0  (2.80) 3209.6  (2.54) 3874.5  (2.55) 4940.3  (2.48) 4773.3  (2.62) 5550.1  (2.70) 3542.9  (2.54) 3960.0  (2.55) 4715.8  (2.51) 5686.7  (2.17) 4404.7  (2.19)
14.Secondary Outcome
Title Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Hide Description

Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.

D=Day

Time Frame Day 1 (Baseline) and Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 31 30 31 30 32 29 30 29 28 29 31
Geometric Mean (Standard Deviation)
Unit of Measure: titer
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31) 1106.6  (4.68) 1249.2  (3.45) 1477.7  (4.13) 1109.2  (4.10) 921.7  (3.15) 1130.9  (4.18) 1340.4  (4.08) 1238.6  (3.92) 1201.2  (3.57) 1473.2  (3.88) 1832.3  (2.69) 977.7  (3.73) 1324.4  (3.34) 1647.0  (3.39)
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31) 1016.8  (5.56) 1232.6  (3.46) 1540.6  (3.83) 1110.4  (3.84) 839.4  (3.04) 1097.8  (4.14) 1268.1  (3.68) 1311.0  (3.98) 1139.9  (3.48) 1494.7  (3.05) 1924.8  (2.52) 8459.4  (2.19) 12901.7  (2.12) 11116.3  (2.55)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30) 4595.7  (3.00) 8636.7  (2.05) 5750.4  (2.15) 4391.5  (2.66) 7545.2  (2.61) 7802.7  (2.03) 3444.6  (2.92) 9945.7  (2.98) 5129.9  (2.91) 10624.2  (2.15) 10034.2  (1.96) 6622.0  (2.22) 9995.5  (2.13) 8164.0  (2.32)
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29) 2341.2  (3.93) 3653.0  (2.24) 2993.2  (3.61) 2887.7  (2.78) 2984.6  (2.62) 3212.2  (2.44) 2251.1  (3.15) 5017.6  (2.82) 2615.1  (2.91) 4531.4  (2.21) 4667.0  (2.20) 3837.9  (2.30) 4693.8  (2.52) 4546.8  (2.26)
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29) 2236.5  (3.84) 3103.0  (3.03) 2450.2  (2.87) 2175.3  (2.91) 1946.4  (2.51) 2173.7  (2.73) 2267.2  (3.29) 2969.9  (2.92) 1898.2  (3.41) 2550.0  (2.29) 2871.1  (2.43) 2425.1  (2.46) 3133.0  (2.50) 3060.7  (2.44)
15.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Hide Description

Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA.

D=Day

Time Frame Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 29 28 29 30 31 30 32 28 30 24 28 29 30
Geometric Mean (Standard Deviation)
Unit of Measure: ratio
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30) 1.0  (1.13) 0.9  (1.18) 0.8  (1.50) 1.2  (2.85) 0.9  (1.26) 1.0  (1.16) 1.0  (1.36) 1.0  (1.18) 0.9  (1.28) 0.9  (1.28) 1.0  (1.58) 19.5  (3.73) 23.2  (3.00) 22.0  (2.57)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) 17.3  (3.69) 18.8  (3.46) 25.8  (3.09) 22.4  (4.38) 22.4  (3.02) 35.1  (3.88) 18.1  (4.35) 19.0  (3.67) 36.5  (4.85) 18.7  (3.31) 13.5  (3.07) 17.0  (3.63) 19.7  (2.78) 16.8  (2.74)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27) 6.9  (3.63) 6.7  (3.71) 9.3  (3.77) 9.0  (4.32) 7.1  (2.63) 10.4  (3.79) 6.4  (3.62) 8.5  (3.90) 10.7  (3.00) 6.5  (2.96) 5.2  (3.27) 9.3  (3.57) 8.3  (2.79) 7.8  (3.52)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28) 4.4  (3.27) 4.1  (4.46) 7.0  (3.56) 8.0  (4.65) 5.1  (2.41) 7.4  (3.36) 5.3  (3.40) 5.7  (3.41) 7.8  (2.87) 4.3  (2.58) 4.0  (3.08) 6.4  (4.07) 6.3  (2.95) 6.1  (2.85)
16.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Hide Description

Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.

D=Day

Time Frame Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 29 28 29 30 31 30 32 28 30 24 28 29 30
Geometric Mean (Standard Deviation)
Unit of Measure: ratio
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30) 0.9  (1.56) 1.0  (1.14) 1.0  (1.23) 1.0  (1.21) 0.9  (1.18) 1.0  (1.13) 0.9  (1.37) 1.1  (1.57) 1.0  (1.17) 1.0  (1.58) 1.0  (1.25) 8.7  (3.25) 9.7  (3.02) 6.7  (3.11)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) 4.2  (3.11) 7.2  (2.98) 4.0  (2.66) 4.1  (2.97) 8.2  (2.72) 6.9  (3.31) 2.6  (2.60) 8.0  (3.36) 4.0  (3.00) 7.2  (3.38) 4.7  (1.97) 6.8  (2.99) 7.5  (2.74) 5.0  (2.70)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27) 2.1  (2.45) 3.0  (2.74) 1.9  (1.96) 2.6  (2.50) 3.2  (2.36) 2.7  (2.21) 1.7  (2.17) 4.1  (2.45) 2.0  (2.06) 3.1  (2.61) 2.2  (1.92) 3.9  (2.70) 3.5  (2.24) 2.5  (2.57)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28) 1.9  (2.77) 2.6  (3.20) 1.7  (2.41) 2.0  (2.33) 2.1  (2.34) 1.9  (1.99) 1.6  (2.46) 2.4  (2.40) 1.5  (2.27) 1.7  (2.41) 1.4  (2.27) 2.5  (2.60) 2.4  (2.22) 1.7  (2.64)
17.Secondary Outcome
Title Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)
Hide Description

Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.

D=Day

Time Frame Baseline and Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 31 30 31 30 32 29 30 29 28 29 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)
0
(0.0 to 11.6)
0
(0.0 to 11.6)
0
(0.0 to 11.9)
0
(0.0 to 11.2)
0
(0.0 to 11.6)
0
(0.0 to 11.2)
3.03
(0.1 to 17.2)
0
(0.0 to 10.9)
0
(0.0 to 12.3)
0
(0.0 to 11.6)
0
(0.0 to 12.8)
71.4
(51.3 to 86.8)
72.4
(52.8 to 87.3)
64.5
(45.4 to 80.8)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)
53.3
(34.3 to 71.7)
58.6
(38.9 to 76.5)
39.3
(21.5 to 59.4)
45.2
(27.3 to 64.0)
70.0
(50.6 to 85.3)
58.1
(39.1 to 75.5)
36.7
(19.9 to 56.1)
65.6
(46.8 to 81.4)
42.9
(24.5 to 62.8)
66.7
(47.2 to 82.7)
50.0
(29.9 to 70.1)
57.1
(37.2 to 75.5)
51.7
(32.5 to 70.6)
46.7
(28.3 to 65.7)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
30.0
(14.7 to 49.4)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
25.0
(11.5 to 43.4)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
13.3
(3.8 to 30.7)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
6.5
(0.8 to 21.4)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Data not collected
18.Secondary Outcome
Title Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)
Hide Description

The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.

D=Day

Time Frame Baseline and Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 29 28 29 30 31 30 32 28 30 24 28 29 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
0
(0.0 to 11.6)
0
(0.0 to 11.9)
0
(0.0 to 12.8)
6.9
(0.8 to 22.8)
0
(0.0 to 11.6)
0
(0.0 to 11.2)
3.3
(0.1 to 17.2)
0
(0.0 to 10.9)
0
(0.0 to 12.8)
0
(0.0 to 11.6)
4.2
(0.1 to 21.1)
96.4
(81.7 to 99.9)
100.0
(88.1 to 100.0)
100.0
(88.4 to 100.0)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
93.3
(77.9 to 99.2)
89.7
(72.6 to 97.8)
100.0
(87.7 to 100.0)
89.7
(72.6 to 97.8)
96.7
(82.8 to 99.9)
100.0
(88.8 to 100.0)
90.0
(73.5 to 97.9)
90.6
(75.0 to 98.0)
96.4
(81.7 to 99.9)
100.0
(88.4 to 100.0)
87.5
(67.6 to 97.3)
96.4
(81.7 to 99.9)
100.0
(88.1 to 100.0)
100.0
(88.4 to 100.0)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
80.0
(61.4 to 92.3)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
71.9
(53.3 to 86.3)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
73.3
(54.1 to 87.7)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
54.8
(36.0 to 72.7)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Data not collected
19.Secondary Outcome
Title Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)
Hide Description

The percentage of participants with a 4-fold rise from or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.

D=Day

Time Frame Baseline and Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 29 28 29 30 31 30 32 28 30 24 28 29 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
0
(0.0 to 11.6)
0
(0.0 to 11.9)
0
(0.0 to 12.8)
0
(0.0 to 11.7)
0
(0.0 to 11.9)
0
(0.0 to 11.2)
3.3
(0.1 to 17.2)
3.1
(0.1 to 16.2)
0
(0.0 to 12.8)
3.3
(0.1 to 17.2)
0
(0.0 to 14.2)
75.0
(55.1 to 89.3)
72.4
(52.8 to 87.3)
63.3
(43.9 to 80.1)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
53.3
(34.3 to 71.7)
65.5
(45.7 to 82.1)
39.3
(21.5 to 59.4)
51.7
(32.5 to 70.6)
73.3
(54.1 to 87.7)
58.1
(39.1 to 75.5)
36.7
(19.9 to 56.1)
68.8
(50.0 to 83.9)
46.4
(27.5 to 66.1)
66.7
(47.2 to 82.7)
54.2
(32.8 to 74.4)
60.7
(40.6 to 78.5)
51.7
(32.5 to 70.6)
46.7
(28.3 to 65.7)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
36.7
(19.9 to 56.1)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
34.4
(18.6 to 53.2)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
23.3
(9.9 to 42.3)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
16.1
(5.5 to 33.7)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Data not collected
20.Secondary Outcome
Title Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)
Hide Description

Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.

D=Day

Time Frame Day 1 (Baseline) and Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 31 30 31 30 32 29 30 29 28 29 31
Geometric Mean (Standard Deviation)
Unit of Measure: titer
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31) 52.9  (4.86) 37.4  (3.59) 42.1  (3.63) 32.1  (5.26) 30.1  (3.26) 44.5  (6.06) 53.6  (5.76) 60.1  (6.45) 36.8  (5.30) 58.5  (4.08) 47.0  (4.91) 73.3  (5.24) 40.8  (4.25) 41.5  (3.74)
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31) 48.9  (4.99) 34.6  (3.38) 41.2  (3.85) 41.0  (4.38) 29.4  (3.31) 46.2  (6.22) 54.4  (5.67) 59.8  (6.23) 37.8  (5.20) 56.3  (3.95) 57.0  (5.31) 1649.9  (4.88) 2148.2  (2.98) 1703.2  (2.62)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30 1358.4  (4.02) 996.2  (5.02) 2223.3  (2.91) 1068.7  (5.39) 1368.6  (3.99) 1849.8  (3.35) 1594.9  (4.87) 1435.5  (7.02) 2074.3  (4.40) 1510.6  (4.45) 1131.2  (4.28) 810.7  (5.58) 922.6  (3.73) 848.2  (3.63)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 302.5  (4.10) NA [1]   (NA) NA [1]   (NA) 512.4  (5.85) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 224.0  (2.73) NA [1]   (NA) NA [1]   (NA) 340.1  (3.91) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
Data not collected
21.Secondary Outcome
Title Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)
Hide Description

Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.

D=Day

Time Frame Day 1 (Baseline) and Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 31 30 31 30 32 29 30 29 28 29 31
Geometric Mean (Standard Deviation)
Unit of Measure: titer
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31) 83.4  (6.63) 113.6  (4.43) 145.5  (4.72) 119.5  (4.47) 72.8  (4.64) 114.6  (4.56) 100.2  (4.47) 133.0  (4.77) 114.3  (4.65) 158.5  (3.41) 201.7  (3.30) 105.9  (4.08) 121.9  (4.16) 174.5  (4.13)
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31) 77.8  (6.49) 110.0  (4.31) 151.2  (4.70) 125.3  (4.34) 73.8  (4.42) 116.3  (4.49) 106.3  (4.05) 139.2  (5.48) 106.3  (4.71) 164.8  (3.16) 218.8  (3.07) 953.5  (2.83) 948.2  (2.52) 1118.0  (2.91)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30) 495.7  (3.30) 840.8  (2.87) 583.7  (2.34) 467.9  (2.79) 803.3  (3.24) 714.2  (2.44) 336.7  (3.74) 1088.9  (3.72) 513.9  (3.82) 1117.7  (3.03) 1027.3  (2.36) 578.8  (3.11) 552.2  (2.60) 691.2  (3.12)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 251.8  (3.94) NA [1]   (NA) NA [1]   (NA) 427.9  (3.95) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 139.7  (4.07) NA [1]   (NA) NA [1]   (NA) 273.4  (3.59) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
Data not collected
22.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)
Hide Description

Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.

D=Day

Time Frame Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 29 28 29 30 31 30 32 28 30 24 28 29 30
Geometric Mean (Standard Deviation)
Unit of Measure: ratio
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30) 0.9  (1.52) 0.9  (1.49) 1.0  (1.23) 1.3  (2.65) 1.0  (1.23) 1.0  (1.14) 1.0  (1.44) 1.0  (1.10) 1.0  (1.13) 1.0  (1.46) 1.2  (1.86) 22.5  (2.95) 52.7  (2.79) 42.3  (2.39)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) 25.7  (4.46) 28.0  (4.40) 49.2  (2.81) 34.2  (5.55) 45.4  (3.47) 41.5  (3.50) 29.8  (4.63) 23.9  (4.13) 52.1  (3.61) 25.8  (3.15) 20.8  (2.77) 11.1  (2.19) 22.6  (2.29) 21.1  (2.81)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 10.0  (2.89) NA [1]   (NA) NA [1]   (NA) 8.5  (3.77) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 7.4  (2.41) NA [1]   (NA) NA [1]   (NA) 5.2  (3.34) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
Data not collected
23.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)
Hide Description

Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.

D=Day

Time Frame Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 29 28 29 30 31 30 32 28 30 24 28 29 30
Geometric Mean (Standard Deviation)
Unit of Measure: ratio
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30) 0.9  (1.33) 1.0  (1.42) 1.0  (1.13) 1.1  (1.27) 1.0  (1.14) 1.0  (1.09) 1.1  (1.44) 1.0  (1.60) 1.0  (1.10) 1.0  (1.36) 1.0  (1.22) 9.0  (2.85) 7.8  (2.89) 6.3  (3.11)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) 5.9  (4.37) 7.7  (3.92) 3.6  (2.45) 4.2  (2.54) 11.0  (3.48) 6.2  (3.36) 3.4  (2.70) 8.2  (3.36) 4.0  (3.14) 7.1  (2.81) 4.9  (2.35) 5.5  (4.74) 4.5  (2.53) 3.9  (2.41)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 3.5  (2.67) NA [1]   (NA) NA [1]   (NA) 3.2  (2.44) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 1.9  (2.47) NA [1]   (NA) NA [1]   (NA) 1.9  (2.26) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
Data not collected
24.Secondary Outcome
Title Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)
Hide Description

Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay.

D=Day

Time Frame Baseline and Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 31 30 31 30 32 29 30 29 28 29 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)
0
(0.0 to 11.6)
0
(0.0 to 11.6)
0
(0.0 to 11.9)
0
(0.0 to 11.2)
0
(0.0 to 11.6)
0
(0.0 to 11.2)
0
(0.0 to 11.6)
0
(0.0 to 10.9)
0
(0.0 to 12.3)
0
(0.0 to 11.6)
0
(0.0 to 12.8)
67.9
(47.6 to 84.1)
62.1
(42.3 to 79.3)
67.7
(48.6 to 83.3)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)
33.3
(17.3 to 52.8)
55.2
(35.7 to 73.6)
32.1
(15.9 to 52.4)
35.5
(19.2 to 54.6)
66.7
(47.2 to 82.7)
51.6
(33.1 to 69.8)
26.7
(12.3 to 45.9)
59.4
(40.6 to 76.3)
28.6
(13.2 to 48.7)
60.0
(40.6 to 77.3)
53.8
(33.4 to 73.4)
75.0
(55.1 to 89.3)
58.6
(38.9 to 76.5)
56.7
(37.4 to 74.5)
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)
10.0
(2.1 to 26.5)
20.7
(8.0 to 39.7)
16.7
(5.6 to 34.7)
6.5
(0.8 to 21.4)
13.3
(3.8 to 30.7)
13.3
(3.8 to 30.7)
20.0
(7.7 to 38.6)
31.3
(16.1 to 50.0)
20.7
(8.0 to 39.7)
16.7
(5.6 to 34.7)
7.4
(0.9 to 24.3)
42.9
(24.5 to 62.8)
34.5
(17.9 to 54.3)
21.4
(8.3 to 41.0)
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)
3.4
(0.1 to 17.8)
13.8
(3.9 to 31.7)
6.7
(0.8 to 22.1)
3.2
(0.1 to 16.7)
6.7
(0.8 to 22.1)
3.4
(0.1 to 17.8)
6.9
(0.8 to 22.8)
9.4
(2.0 to 25.0)
3.4
(0.1 to 17.8)
3.3
(0.1 to 17.2)
3.7
(0.1 to 19.0)
7.1
(0.9 to 23.5)
10.3
(2.2 to 27.4)
7.1
(0.9 to 23.5)
25.Secondary Outcome
Title Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)
Hide Description

The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by HBGA binding assay.

D=Day

Time Frame Baseline and Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Set included all participants who received both doses of study drug and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 29 28 29 30 31 30 32 28 30 24 28 29 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
0
(0.0 to 11.6)
0
(0.0 to 11.9)
0
(0.0 to 12.8)
0
(0.0 to 11.9)
0
(0.0 to 11.6)
0
(0.0 to 11.2)
0
(0.0 to 11.6)
0
(0.0 to 10.9)
0
(0.0 to 12.8)
0
(0.0 to 11.6)
0
(0.0 to 14.2)
82.1
(63.1 to 93.9)
96.6
(82.2 to 99.9)
93.3
(77.9 to 99.2)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
80.0
(61.4 to 92.3)
79.3
(60.3 to 92.0)
85.7
(67.3 to 96.0)
82.8
(64.2 to 94.2)
86.7
(69.3 to 96.2)
87.1
(70.2 to 96.4)
76.7
(57.7 to 90.1)
78.1
(60.0 to 90.7)
85.7
(67.3 to 96.0)
90.0
(73.5 to 97.9)
70.8
(48.9 to 87.4)
100.0
(87.7 to 100.0)
96.6
(82.2 to 99.9)
93.3
(77.9 to 99.2)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)
53.3
(34.3 to 71.7)
65.5
(45.7 to 82.1)
67.9
(47.6 to 84.1)
58.6
(38.9 to 76.5)
43.3
(25.5 to 62.6)
70.0
(50.6 to 85.3)
60.0
(40.6 to 77.3)
78.1
(60.0 to 90.7)
82.1
(63.1 to 93.9)
56.7
(37.4 to 74.5)
33.3
(15.6 to 55.3)
85.7
(67.3 to 96.0)
93.1
(77.2 to 99.2)
77.8
(57.7 to 91.4)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)
31.0
(15.3 to 50.8)
32.1
(15.9 to 52.4)
50.0
(30.6 to 69.4)
37.9
(20.7 to 57.7)
23.3
(9.9 to 42.3)
37.9
(20.7 to 57.7)
44.8
(26.4 to 64.3)
53.1
(34.7 to 70.9)
53.6
(33.9 to 72.5)
26.7
(12.3 to 45.9)
29.2
(12.6 to 51.1)
50.0
(30.6 to 69.4)
51.7
(32.5 to 70.6)
46.4
(27.5 to 66.1)
26.Secondary Outcome
Title Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)
Hide Description

The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by HBGA binding assay.

D=Day

Time Frame Baseline and Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Set included all participants who received both doses of study drug and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 29 28 29 30 31 30 32 28 30 24 28 29 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)
3.3
(0.1 to 17.2)
0
(0.0 to 11.9)
3.7
(0.1 to 19.0)
0
(0.0 to 11.9)
3.3
(0.1 to 17.2)
0
(0.0 to 11.2)
0
(0.0 to 11.6)
3.1
(0.1 to 16.2)
3.7
(0.1 to 19.0)
3.3
(0.1 to 17.2)
0
(0.0 to 14.2)
82.1
(63.1 to 93.9)
65.5
(45.7 to 82.1)
70.0
(50.6 to 85.3)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)
46.7
(28.3 to 65.7)
72.4
(52.8 to 87.3)
39.3
(21.5 to 59.4)
41.4
(23.5 to 61.1)
80.0
(61.4 to 92.3)
61.3
(42.2 to 78.2)
26.7
(12.3 to 45.9)
71.9
(53.3 to 86.3)
35.7
(18.6 to 55.9)
63.3
(43.9 to 80.1)
66.7
(44.7 to 84.4)
75.0
(55.1 to 89.3)
58.6
(38.9 to 76.5)
60.0
(40.6 to 77.3)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)
26.7
(12.3 to 45.9)
31.0
(15.3 to 50.8)
17.9
(6.1 to 36.9)
20.7
(8.0 to 39.7)
43.3
(25.5 to 62.6)
20.0
(7.7 to 38.6)
20.0
(7.7 to 38.6)
43.8
(26.4 to 62.3)
21.4
(8.3 to 41.0)
33.3
(17.3 to 52.8)
25.0
(9.8 to 46.7)
50.0
(30.6 to 69.4)
37.9
(20.7 to 57.7)
22.2
(8.6 to 42.3)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)
13.8
(3.9 to 31.7)
21.4
(8.3 to 41.0)
3.6
(0.1 to 18.3)
17.2
(5.8 to 35.8)
23.3
(9.9 to 42.3)
3.4
(0.1 to 17.8)
10.3
(2.2 to 27.4)
12.5
(3.5 to 29.0)
10.7
(2.3 to 28.2)
16.7
(5.6 to 34.7)
4.2
(0.1 to 21.1)
21.4
(8.3 to 41.0)
24.1
(10.3 to 43.5)
10.7
(2.3 to 28.2)
27.Secondary Outcome
Title Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)
Hide Description

Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.

D=Day

Time Frame Baseline (Day 1) and Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 31 30 31 30 32 29 30 29 28 29 31
Geometric Mean (Standard Deviation)
Unit of Measure: titer
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31) 24.8  (2.75) 18.7  (1.85) 26.0  (2.73) 26.8  (3.35) 19.1  (1.68) 24.8  (2.31) 30.5  (3.04) 24.5  (2.59) 23.8  (2.46) 23.2  (2.19) 26.3  (2.68) 23.1  (2.25) 22.3  (2.26) 20.6  (2.04)
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31) 25.0  (2.60) 18.6  (1.86) 23.8  (2.44) 26.7  (3.19) 18.6  (1.70) 23.0  (2.24) 27.3  (2.46) 25.1  (2.52) 25.5  (2.52) 24.8  (2.37) 28.5  (2.66) 347.6  (4.62) 385.9  (3.64) 391.1  (3.56)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30) 280.5  (3.94) 236.3  (4.61) 403.3  (3.74) 286.9  (5.01) 22.86  (3.94) 356.4  (3.74) 400.1  (3.33) 412.9  (4.78) 510.0  (4.36) 247.2  (3.43) 271.3  (5.00) 398.6  (2.70) 463.5  (2.32) 355.8  (2.58)
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29) 130.0  (3.38) 98.2  (3.46) 159.0  (3.23) 136.4  (3.67) 80.1  (3.49) 139.3  (2.68) 159.8  (2.73) 202.1  (3.34) 208.6  (3.28) 114.5  (2.89) 107.9  (3.28) 196.4  (2.86) 219.2  (2.29) 182.0  (2.40)
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29) 67.8  (3.78) 51.3  (3.23) 88.1  (3.54) 74.8  (4.26) 44.0  (3.39) 71.9  (3.40) 91.5  (3.14) 107.5  (3.97) 99.6  (4.09) 55.0  (3.22) 66.1  (3.86) 103.4  (3.95) 113.6  (3.30) 81.0  (2.85)
28.Secondary Outcome
Title Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)
Hide Description

Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay.

D=Day

Time Frame Day 1 (Baseline) and Days 28, 56, 208 and 393
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Hide Analysis Population Description
Full Analysis Set included all participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 30 30 31 30 31 30 32 29 30 29 28 29 31
Geometric Mean (Standard Deviation)
Unit of Measure: titer
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31) 66.0  (4.85) 80.1  (3.44) 115.3  (4.24) 91.4  (4.15) 60.9  (3.84) 96.6  (4.03) 80.7  (4.48) 89.8  (4.41) 96.2  (3.93) 102.3  (3.39) 121.9  (3.47) 56.1  (3.48) 92.0  (3.96) 117.8  (3.91)
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31) 69.3  (4.56) 75.7  (3.63) 124.9  (3.98) 87.9  (3.75) 67.7  (3.76) 94.5  (4.30) 74.6  (4.17) 98.1  (5.11) 92.9  (3.87) 123.3  (3.25) 117.6  (3.62) 552.6  (3.65) 688.4  (3.16) 904.4  (2.67)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30) 336.9  (3.40) 686.3  (3.47) 429.0  (2.40) 317.8  (2.94) 675.7  (3.21) 632.1  (2.11) 189.2  (4.63) 842.8  (3.23) 360.1  (3.85) 862.8  (3.12) 778.0  (2.57) 426.5  (3.46) 596.3  (2.86) 604.4  (2.91)
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29) 186.7  (3.19) 241.5  (3.24) 244.6  (2.78) 206.3  (2.84) 229.9  (3.60) 259.7  (2.66) 142.5  (4.09) 346.8  (2.92) 201.0  (3.49) 340.6  (2.60) 324.6  (3.07) 277.5  (2.53) 350.9  (2.36) 295.3  (3.07)
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28) 120.5  (4.21) 180.2  (3.95) 123.5  (3.87) 133.2  (3.81) 104.7  (4.01) 134.4  (3.74) 109.3  (4.44) 182.9  (3.60) 121.9  (3.88) 179.7  (2.53) 209.0  (3.38) 126.2  (3.56) 171.2  (3.61) 192.9  (3.52)
29.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)
Hide Description

Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.

D=Day

Time Frame Days 28, 56, 208 and 393
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Hide Analysis Population Description
Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 29 28 29 30 31 30 32 28 30 24 28 29 30
Geometric Mean (Standard Deviation)
Unit of Measure: titer
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30) 1.0  (1.30) 1.0  (1.08) 0.9  (1.30) 1.0  (1.21) 1.0  (1.37) 0.9  (1.26) 0.9  (1.59) 1.0  (1.22) 1.1  (1.37) 1.1  (1.28) 1.0  (1.31) 15.0  (3.80) 17.3  (3.02) 19.3  (3.33)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) 11.3  (4.25) 13.2  (4.31) 14.9  (3.54) 10.0  (4.07) 12.0  (3.36) 14.3  (2.98) 13.1  (3.96) 16.9  (4.60) 21.1  (3.72) 10.7  (2.53) 9.7  (4.29) 17.2  (2.36) 20.8  (2.20) 17.9  (2.68)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27) 5.2  (3.41) 5.5  (3.18) 6.0  (2.97) 4.8  (2.91) 4.2  (2.94) 5.9  (2.00) 5.2  (2.69) 8.2  (3.14) 8.6  (2.63) 4.9  (2.24) 3.7  (2.95) 8.5  (2.52) 9.8  (2.18) 7.9  (2.21)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28) 2.7  (3.29) 2.7  (2.71) 3.3  (2.87) 2.6  (2.97) 2.3  (2.65) 3.0  (2.35) 2.9  (2.61) 4.4  (3.30) 4.0  (3.10) 2.4  (2.35) 2.4  (2.73) 4.5  (3.29) 5.1  (2.81) 3.8  (2.60)
30.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)
Hide Description

Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay.

D=Day

Time Frame Days 28, 56, 208 and 393
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Hide Arm/Group Description:
Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 29 28 29 30 31 30 32 28 30 24 28 29 30
Geometric Mean (Standard Deviation)
Unit of Measure: titer
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30) 1.1  (1.68) 0.9  (1.59) 1.0  (1.47) 1.0  (1.73) 1.1  (1.62) 1.0  (1.38) 0.9  (1.29) 1.1  (1.89) 1.0  (1.59) 1.2  (2.45) 1.0  (1.46) 9.8  (3.48) 7.5  (3.13) 7.0  (2.96)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) 5.1  (4.42) 8.9  (3.31) 3.6  (2.71) 3.7  (3.43) 11.1  (3.32) 6.5  (3.33) 2.3  (2.95) 9.4  (3.95) 3.5  (3.61) 8.4  (3.59) 6.0  (2.24) 7.6  (3.19) 6.5  (2.94) 4.8  (2.46)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27) 2.8  (3.10) 3.1  (2.51) 2.0  (2.42) 2.4  (2.58) 3.8  (2.56) 2.5  (1.99) 1.8  (2.27) 3.9  (3.03) 2.0  (2.30) 3.3  (2.66) 2.5  (1.73) 4.9  (2.72) 3.8  (2.81) 2.5  (2.35)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28) 1.7  (3.14) 2.3  (2.42) 1.0  (2.43) 1.5  (2.56) 1.7  (2.32) 1.4  (1.82) 1.3  (2.25) 2.0  (2.59) 1.3  (2.28) 1.8  (2.11) 1.6  (1.90) 2.2  (2.70) 1.9  (2.62) 1.4  (2.23)
31.Secondary Outcome
Title GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)
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GMFR of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay.

D=Day

Time Frame Days 28, 56, 208 and 393
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Hide Analysis Population Description
Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title GI.1/GII.4 (15/15) - MPL (50) GI.1/GII.4 (15/50) - MPL (50) GI.1/GII.4 (50/50) - MPL (50) GI.1/GII.4 (15/15) - MPL (15) GI.1/GII.4 (15/50) - MPL (15) GI.1/GII.4 (50/50) - MPL (15) GI.1/GII.4 (15/15) GI.1/GII.4 (15/50) GI.1/GII.4 (50/50) GI.1/GII.4 (50/150) GI.1/GII.4 (15/50) - Al(OH)3 (167) GI.1/GII.4 (15/50) x2 GI.1/GII.4 (50/150) x2 GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
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Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
Overall Number of Participants Analyzed 30 29 28 29 30 31 30 32 28 30 24 28 29 30
Geometric Mean (Standard Deviation)
Unit of Measure: titer
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30) 1.0  (1.17) 1.0  (1.18) 0.9  (1.12) 1.0  (1.22) 1.0  (1.11) 0.9  (1.22) 0.9  (1.18) 1.0  (1.67) 0.9  (1.98) 1.0  (1.12) 1.0  (1.13) 7.4  (2.97) 4.5  (2.94) 5.7  (3.01)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) 3.4  (2.91) 5.1  (2.78) 1.7  (1.81) 2.6  (2.78) 4.2  (3.20) 3.7  (3.17) 1.6  (2.06) 5.9  (4.17) 2.7  (3.16) 4.6  (2.73) 3.1  (2.36) 4.6  (2.94) 3.6  (2.62) 4.0  (2.45)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 1.8  (2.34) NA [1]   (NA) NA [1]   (NA) 2.4  (2.89) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 1.4  (2.08) NA [1]   (NA) NA [1]   (NA) 1.9  (2.56) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
Data not collected
32.Secondary Outcome
Title GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)