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Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults

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: NCT03039790
Recruitment Status : Completed
First Posted : February 1, 2017
Results First Posted : October 6, 2022
Last Update Posted : November 9, 2022
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Healthy Volunteers
Norovirus
Intervention Biological: NoV Vaccine
Enrollment 528
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
Hide Arm/Group Description Eligible NOR-107 participants who had received 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 (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study. Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
Period Title: Overall Study
Started 25 19 27 27 23 27 25 28 22 28 21 25 24 24 24 29 39 14 35 42
Per Protocol Set (PPS) [1] 25 19 27 26 23 27 25 28 22 28 19 25 24 24 24 29 39 14 35 42
Completed 21 19 26 25 23 26 24 27 22 26 20 25 21 24 20 22 29 12 29 34
Not Completed 4 0 1 2 0 1 1 1 0 2 1 0 3 0 4 7 10 2 6 8
Reason Not Completed
Lost to Follow-up             2             0             1             1             0             1             1             1             0             1             1             0             1             0             3             1             2             2             1             3
Withdrawal of Consent             1             0             0             1             0             0             0             0             0             1             0             0             2             0             1             5             3             0             2             5
Death             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             3             0             2             0
Reason, not Specified             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             2             0             1             0
[1]
PPS included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint.
Arm/Group Title NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose NOR-107: GI.1/GII.4 (15/150/167) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose Total
Hide Arm/Group Description Eligible NOR-107 participants who had received 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 (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study. Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. Total of all reporting groups
Overall Number of Baseline Participants 25 19 27 27 23 27 25 28 22 28 21 25 24 24 24 29 39 14 35 42 528
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) included all participants with data from at least 1 follow-up time point.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 19 participants 27 participants 27 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 21 participants 25 participants 24 participants 24 participants 24 participants 29 participants 39 participants 14 participants 35 participants 42 participants 528 participants
48.1  (14.24) 47.9  (14.60) 46.8  (13.39) 47.5  (13.96) 48.0  (13.49) 48.0  (13.13) 45.4  (13.63) 46.8  (13.59) 45.5  (13.23) 44.0  (15.20) 41.9  (16.17) 42.6  (13.33) 47.3  (13.98) 46.3  (15.17) 35.0  (9.44) 73.6  (8.50) 77.2  (9.48) 35.6  (7.27) 76.9  (9.94) 76.1  (8.41) 53.6  (18.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 19 participants 27 participants 27 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 21 participants 25 participants 24 participants 24 participants 24 participants 29 participants 39 participants 14 participants 35 participants 42 participants 528 participants
Female
16
  64.0%
13
  68.4%
19
  70.4%
20
  74.1%
14
  60.9%
21
  77.8%
12
  48.0%
14
  50.0%
16
  72.7%
21
  75.0%
12
  57.1%
15
  60.0%
18
  75.0%
16
  66.7%
10
  41.7%
20
  69.0%
19
  48.7%
7
  50.0%
18
  51.4%
23
  54.8%
324
  61.4%
Male
9
  36.0%
6
  31.6%
8
  29.6%
7
  25.9%
9
  39.1%
6
  22.2%
13
  52.0%
14
  50.0%
6
  27.3%
7
  25.0%
9
  42.9%
10
  40.0%
6
  25.0%
8
  33.3%
14
  58.3%
9
  31.0%
20
  51.3%
7
  50.0%
17
  48.6%
19
  45.2%
204
  38.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 19 participants 27 participants 27 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 21 participants 25 participants 24 participants 24 participants 24 participants 29 participants 39 participants 14 participants 35 participants 42 participants 528 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5
  20.8%
1
   3.4%
2
   5.1%
1
   7.1%
3
   8.6%
3
   7.1%
15
   2.8%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
19
  79.2%
28
  96.6%
37
  94.9%
13
  92.9%
32
  91.4%
39
  92.9%
168
  31.8%
Unknown or Not Reported
25
 100.0%
19
 100.0%
27
 100.0%
27
 100.0%
23
 100.0%
27
 100.0%
25
 100.0%
28
 100.0%
22
 100.0%
28
 100.0%
21
 100.0%
25
 100.0%
24
 100.0%
24
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
345
  65.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 19 participants 27 participants 27 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 21 participants 25 participants 24 participants 24 participants 24 participants 29 participants 39 participants 14 participants 35 participants 42 participants 528 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.7%
0
   0.0%
1
   3.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
4
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
0
   0.0%
1
   0.2%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7
  29.2%
1
   3.4%
0
   0.0%
1
   7.1%
0
   0.0%
3
   7.1%
12
   2.3%
White
25
 100.0%
19
 100.0%
27
 100.0%
26
  96.3%
23
 100.0%
26
  96.3%
25
 100.0%
28
 100.0%
22
 100.0%
27
  96.4%
21
 100.0%
25
 100.0%
24
 100.0%
24
 100.0%
16
  66.7%
28
  96.6%
38
  97.4%
12
  85.7%
35
 100.0%
39
  92.9%
510
  96.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 19 participants 27 participants 27 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 21 participants 25 participants 24 participants 24 participants 24 participants 29 participants 39 participants 14 participants 35 participants 42 participants 528 participants
Belgium
25
 100.0%
19
 100.0%
27
 100.0%
27
 100.0%
23
 100.0%
27
 100.0%
25
 100.0%
28
 100.0%
22
 100.0%
28
 100.0%
21
 100.0%
25
 100.0%
24
 100.0%
24
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
345
  65.3%
United States
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
24
 100.0%
29
 100.0%
39
 100.0%
14
 100.0%
35
 100.0%
42
 100.0%
183
  34.7%
1.Primary Outcome
Title Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay
Hide Description GMBT50 of anti-norovirus GI. VLP antibody titers as measured by the histo-blood group antigen (HBGA) blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204) , at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107, NOR-210, NOR-204)
Time Frame Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set (PPS) included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.
Arm/Group Title NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
Hide Arm/Group Description:
Eligible NOR-107 participants who had received 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 (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
Overall Number of Participants Analyzed 25 19 27 26 23 27 25 28 22 28 19 25 24 24 24 29 39 14 35 42
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Baseline Number Analyzed 25 participants 19 participants 27 participants 26 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 19 participants 25 participants 24 participants 24 participants 24 participants 29 participants 39 participants 14 participants 35 participants 42 participants
27.4
(17.5 to 42.9)
18.3
(13.4 to 24.9)
26.3
(17.4 to 39.6)
24.6
(15.5 to 38.9)
19.0
(15.5 to 23.2)
23.9
(17.2 to 33.2)
35.1
(21.7 to 56.9)
24.3
(16.5 to 35.8)
26.1
(16.8 to 40.5)
23.9
(17.5 to 32.7)
33.4
(19.4 to 57.6)
23.1
(16.4 to 32.6)
22.9
(15.9 to 32.9)
21.3
(15.4 to 29.3)
19.0
(14.1 to 25.6)
20.8
(16.4 to 26.3)
28.9
(20.7 to 40.5)
18.7
(13.0 to 26.9)
23.9
(18.5 to 30.8)
26.4
(19.4 to 36.1)
Days 28 Number Analyzed 25 participants 19 participants 26 participants 26 participants 23 participants 27 participants 25 participants 28 participants 21 participants 28 participants 19 participants 25 participants 24 participants 24 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
27.7
(18.2 to 42.2)
18.1
(13.2 to 24.8)
23.8
(16.4 to 34.5)
24.0
(15.4 to 37.3)
17.4
(14.5 to 20.9)
21.9
(16.1 to 29.9)
29.9
(20.2 to 44.2)
24.9
(17.2 to 36.1)
27.3
(17.2 to 43.4)
25.8
(18.3 to 36.3)
34.9
(20.8 to 58.5)
382.6
(200.9 to 728.5)
338.0
(196.7 to 580.7)
449.4
(270.5 to 746.5)
Days 29 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 24 participants 29 participants 39 participants 14 participants 35 participants 42 participants
212.5
(129.9 to 347.5)
21.3
(16.9 to 26.9)
28.7
(20.6 to 40.0)
19.9
(13.5 to 29.2)
342.5
(206.3 to 568.5)
329.2
(213.3 to 508.2)
Day 36 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 29 participants 39 participants 14 participants 35 participants 42 participants
263.3
(143.3 to 483.9)
213.4
(117.2 to 388.5)
155.3
(51.5 to 468.2)
406.4
(274.6 to 601.4)
307.2
(206.1 to 458.0)
Day 56 Number Analyzed 25 participants 19 participants 27 participants 26 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 19 participants 25 participants 24 participants 24 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
309.7
(168.7 to 568.4)
256.9
(136.3 to 484.0)
380.9
(227.0 to 639.2)
255.4
(132.3 to 493.1)
252.9
(136.7 to 468.1)
329.2
(192.9 to 561.9)
369.5
(221.0 to 617.8)
350.4
(194.5 to 631.2)
527.0
(264.1 to 1051.5)
274.3
(171.6 to 438.4)
315.8
(154.5 to 645.2)
435.9
(288.8 to 658.0)
427.6
(300.0 to 609.6)
377.4
(251.6 to 566.0)
Day 57 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 29 participants 39 participants 14 participants 35 participants 42 participants
228.9
(136.4 to 384.1)
223.0
(133.9 to 371.5)
105.1
(40.9 to 270.5)
362.5
(255.9 to 513.5)
304.3
(215.6 to 429.7)
Day 208 Number Analyzed 25 participants 19 participants 27 participants 26 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 19 participants 25 participants 24 participants 24 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
143.5
(84.7 to 243.2)
109.1
(62.9 to 189.1)
154.8
(95.7 to 250.4)
125.6
(74.9 to 210.8)
86.4
(50.5 to 148.1)
137.9
(93.7 to 202.8)
168.9
(109.1 to 261.5)
175.4
(111.6 to 275.6)
214.1
(120.7 to 379.6)
125.3
(83.7 to 187.6)
115.3
(61.5 to 216.0)
208.7
(134.0 to 324.9)
201.5
(141.3 to 287.4)
185.6
(126.9 to 271.6)
Day 211 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 29 participants 39 participants 14 participants 35 participants 42 participants
115.9
(72.1 to 186.4)
96.5
(62.6 to 148.7)
43.4
(20.1 to 93.9)
132.9
(89.2 to 198.0)
126.6
(85.6 to 187.2)
Year 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 24 participants 26 participants 37 participants 14 participants 32 participants 34 participants
48.8
(31.2 to 76.4)
46.3
(30.7 to 69.8)
63.6
(39.6 to 102.1)
38.9
(16.7 to 90.6)
58.9
(39.8 to 87.2)
83.4
(58.2 to 119.3)
Year 3 Number Analyzed 24 participants 19 participants 27 participants 26 participants 23 participants 26 participants 25 participants 28 participants 22 participants 27 participants 19 participants 25 participants 24 participants 24 participants 21 participants 24 participants 35 participants 13 participants 29 participants 37 participants
79.6
(48.9 to 129.7)
53.7
(32.8 to 88.0)
77.2
(49.1 to 121.3)
72.4
(44.0 to 119.1)
51.5
(33.1 to 80.1)
55.5
(35.4 to 86.8)
98.0
(65.1 to 147.5)
90.2
(60.1 to 135.5)
102.2
(56.4 to 185.0)
61.8
(40.5 to 94.3)
67.2
(34.5 to 131.1)
90.5
(55.4 to 147.6)
84.9
(53.1 to 135.6)
85.7
(55.9 to 131.4)
48.2
(29.0 to 80.1)
48.8
(30.3 to 78.8)
60.7
(37.2 to 98.9)
34.0
(16.6 to 69.9)
72.5
(47.3 to 111.2)
76.1
(51.0 to 113.6)
Year 4 Number Analyzed 23 participants 19 participants 26 participants 26 participants 23 participants 26 participants 23 participants 28 participants 22 participants 28 participants 19 participants 25 participants 23 participants 24 participants 20 participants 18 participants 22 participants 11 participants 20 participants 27 participants
70.5
(38.0 to 130.9)
47.5
(27.3 to 82.7)
68.6
(38.6 to 122.0)
54.0
(30.4 to 96.1)
54.8
(30.2 to 99.7)
49.3
(31.5 to 77.2)
84.9
(49.6 to 145.2)
67.3
(41.1 to 109.9)
78.2
(41.9 to 146.1)
45.5
(30.0 to 68.9)
61.2
(30.9 to 121.0)
85.8
(57.9 to 127.0)
65.1
(39.0 to 108.8)
67.2
(42.9 to 105.2)
63.8
(35.0 to 116.2)
28.6
(17.3 to 47.2)
45.9
(25.0 to 84.3)
28.3
(14.2 to 56.2)
76.1
(45.6 to 127.2)
57.1
(34.5 to 94.3)
Year 5 Number Analyzed 21 participants 19 participants 26 participants 24 participants 23 participants 26 participants 24 participants 27 participants 22 participants 25 participants 19 participants 24 participants 21 participants 24 participants 19 participants 8 participants 13 participants 10 participants 10 participants 16 participants
71.0
(37.8 to 133.6)
42.5
(25.0 to 72.4)
80.5
(45.0 to 144.0)
54.4
(30.8 to 96.2)
50.5
(28.7 to 89.1)
54.5
(31.0 to 96.0)
77.2
(48.4 to 123.1)
82.2
(49.0 to 137.7)
80.9
(43.3 to 151.1)
54.1
(32.6 to 89.7)
62.0
(32.5 to 118.5)
82.1
(50.9 to 132.4)
69.1
(42.3 to 112.6)
74.9
(49.1 to 114.2)
52.8
(28.6 to 97.4)
34.7
(15.8 to 76.1)
41.9
(21.8 to 80.3)
31.9
(14.6 to 69.6)
59.8
(29.0 to 123.2)
65.5
(37.9 to 113.1)
2.Primary Outcome
Title Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay
Hide Description GMBT50 of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3 4 and 5 (NOR-107,NOR-210, NOR-204) .
Time Frame Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study
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Hide Analysis Population Description
PPS included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.
Arm/Group Title NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/15/167) μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg,2-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
Hide Arm/Group Description:
Eligible NOR-107 participants who had received 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 (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible participants who received 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 aluminium hydroxide, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 in previous study NOR-210 were enrolled at 2nd year post-primary vaccination in this study.
Eligible participants ≥ 60 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Eligible participants 60-94 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Eligible participants 18 to 49 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Overall Number of Participants Analyzed 25 19 27 26 23 27 25 28 22 28 19 25 24 24 24 29 39 14 35 42
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Baseline Number Analyzed 25 participants 19 participants 27 participants 26 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 19 participants 25 participants 24 participants 24 participants 24 participants 29 participants 39 participants 14 participants 35 participants 42 participants
74.8
(38.1 to 147.0)
77.4
(41.9 to 142.8)
116.8
(65.9 to 207.2)
72.1
(41.6 to 125.1)
54.6
(30.7 to 97.3)
104.2
(60.4 to 179.8)
77.5
(42.5 to 141.6)
86.3
(47.9 to 155.3)
97.1
(55.8 to 169.0)
106.1
(66.7 to 168.8)
124.3
(69.0 to 223.9)
65.8
(39.6 to 109.1)
97.2
(53.8 to 175.9)
127.3
(70.2 to 231.0)
42.7
(25.6 to 71.1)
140.5
(78.5 to 251.6)
71.8
(45.7 to 113.0)
97.5
(40.3 to 235.8)
104.9
(64.2 to 171.5)
111.0
(72.0 to 171.1)
Day 28 Number Analyzed 25 participants 19 participants 26 participants 26 participants 23 participants 27 participants 25 participants 28 participants 21 participants 28 participants 19 participants 25 participants 24 participants 24 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
80.7
(42.3 to 153.9)
67.2
(35.2 to 128.0)
128.0
(73.3 to 223.7)
71.3
(42.2 to 120.7)
64.9
(36.6 to 115.3)
101.3
(57.1 to 179.6)
69.7
(40.2 to 120.9)
95.2
(49.6 to 182.6)
84.1
(46.7 to 151.3)
129.9
(83.4 to 202.4)
112.4
(63.0 to 200.5)
607.7
(379.2 to 974.0)
668.3
(397.3 to 1124.0)
893.6
(578.4 to 1380.5)
Day 29 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 24 participants 29 participants 39 participants 14 participants 35 participants 42 participants
665.9
(408.2 to 1086.2)
118.3
(66.7 to 210.0)
63.5
(41.0 to 98.4)
83.2
(34.3 to 201.9)
1134.4
(784.6 to 1640.1)
824.2
(493.4 to 1376.8)
Day 36 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 29 participants 39 participants 14 participants 35 participants 42 participants
920.9
(521.8 to 1625.4)
518.7
(273.0 to 985.2)
1037.4
(448.1 to 2401.9)
1016.2
(719.4 to 1435.4)
766.8
(483.1 to 1216.9)
Day 56 Number Analyzed 25 participants 19 participants 27 participants 26 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 19 participants 25 participants 24 participants 24 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
367.9
(214.8 to 630.3)
755.9
(425.6 to 1342.6)
425.1
(298.8 to 604.8)
277.9
(178.2 to 433.4)
584.7
(367.5 to 930.1)
593.4
(436.2 to 807.2)
201.9
(110.6 to 368.4)
810.0
(507.4 to 1293.2)
328.5
(173.8 to 620.8)
886.3
(562.3 to 1397.0)
746.6
(456.8 to 1220.3)
458.4
(290.9 to 722.3)
575.5
(358.1 to 924.8)
594.2
(369.2 to 956.2)
Day 57 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 29 participants 39 participants 14 participants 35 participants 42 participants
1133.2
(682.7 to 1881.0)
471.8
(285.2 to 780.5)
663.8
(304.5 to 1447.1)
740.2
(549.0 to 998.0)
589.1
(359.7 to 964.6)
Day 208 Number Analyzed 25 participants 19 participants 27 participants 26 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 19 participants 25 participants 24 participants 24 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
216.4
(132.8 to 352.6)
290.1
(182.7 to 460.7)
231.4
(152.0 to 352.4)
176.2
(116.1 to 267.4)
215.9
(132.1 to 353.1)
247.4
(166.6 to 367.3)
150.4
(87.4 to 258.6)
333.2
(217.9 to 509.4)
173.0
(94.8 to 315.8)
352.9
(242.4 to 513.8)
274.9
(151.4 to 499.2)
277.2
(186.5 to 412.0)
342.5
(233.2 to 503.1)
308.7
(198.5 to 480.0)
Day 211 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 29 participants 39 participants 14 participants 35 participants 42 participants
417.6
(252.8 to 689.6)
195.2
(120.2 to 316.8)
274.7
(135.3 to 557.8)
374.7
(262.6 to 534.6)
265.3
(157.4 to 447.2)
Year 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 24 participants 26 participants 37 participants 10 participants 32 participants 35 participants
105.2
(58.7 to 188.3)
223.2
(120.7 to 412.9)
122.5
(74.8 to 200.5)
250.5
(80.8 to 776.7)
220.9
(137.2 to 355.7)
243.0
(149.6 to 394.7)
Year 3 Number Analyzed 24 participants 19 participants 27 participants 26 participants 23 participants 27 participants 25 participants 28 participants 22 participants 27 participants 19 participants 25 participants 24 participants 24 participants 21 participants 24 participants 35 participants 13 participants 29 participants 37 participants
122.7
(65.7 to 229.2)
177.1
(96.8 to 323.9)
117.9
(69.6 to 199.7)
104.0
(60.2 to 179.6)
80.5
(45.4 to 142.9)
125.9
(74.7 to 212.3)
121.2
(71.1 to 206.7)
164.1
(97.7 to 275.5)
125.3
(67.9 to 230.9)
167.0
(111.3 to 250.4)
142.2
(76.9 to 263.1)
149.2
(83.1 to 267.9)
144.7
(83.1 to 251.7)
173.8
(104.6 to 288.8)
87.5
(43.9 to 174.5)
172.0
(100.1 to 295.5)
94.9
(59.4 to 151.3)
133.8
(56.2 to 318.9)
153.3
(100.1 to 234.8)
162.4
(102.5 to 257.3)
Year 4 Number Analyzed 23 participants 19 participants 26 participants 26 participants 23 participants 26 participants 23 participants 28 participants 22 participants 28 participants 19 participants 25 participants 23 participants 24 participants 20 participants 18 participants 22 participants 11 participants 20 participants 27 participants
85.7
(46.7 to 157.1)
122.8
(67.4 to 223.6)
90.8
(54.4 to 151.3)
79.5
(48.3 to 130.8)
61.7
(35.7 to 106.5)
106.7
(64.7 to 176.1)
108.6
(62.0 to 190.3)
131.2
(81.9 to 210.2)
101.9
(60.1 to 172.7)
113.9
(73.3 to 177.1)
130.1
(70.0 to 241.9)
98.1
(55.0 to 175.1)
104.4
(58.4 to 186.5)
120.3
(72.6 to 199.3)
84.1
(44.2 to 160.3)
116.0
(54.0 to 249.4)
80.9
(42.1 to 155.4)
131.1
(57.6 to 298.6)
241.9
(140.2 to 417.5)
136.7
(75.7 to 246.9)
Year 5 Number Analyzed 21 participants 19 participants 26 participants 24 participants 23 participants 26 participants 24 participants 27 participants 22 participants 25 participants 19 participants 24 participants 21 participants 24 participants 19 participants 8 participants 14 participants 10 participants 10 participants 17 participants
101.1
(52.5 to 194.6)
138.3
(80.8 to 236.9)
124.4
(78.5 to 197.0)
91.2
(51.2 to 162.3)
71.3
(40.0 to 126.9)
103.2
(60.6 to 175.8)
94.3
(54.4 to 163.2)
144.9
(82.9 to 253.1)
105.1
(57.8 to 191.1)
147.2
(92.4 to 234.4)
118.0
(66.8 to 208.6)
118.3
(71.4 to 195.8)
115.7
(57.7 to 232.0)
132.0
(79.7 to 218.5)
94.2
(49.1 to 180.7)
123.4
(26.5 to 574.3)
66.8
(32.2 to 138.6)
107.4
(43.5 to 265.1)
202.2
(110.2 to 370.9)
187.3
(105.6 to 332.4)
3.Secondary Outcome
Title Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)
Hide Description GMT of anti-norovirus GI.1 VLP antibody titers as measured by total immunoglobulin (pan-Ig) enzyme-linked immunoassay (ELISA). Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5(NOR-107,NOR-210, NOR-204).
Time Frame Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study
Hide Outcome Measure Data
Hide Analysis Population Description
PPS included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.
Arm/Group Title NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
Hide Arm/Group Description:
Eligible NOR-107 participants who had received 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 (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 in previous study NOR-210 were enrolled at 2nd year post-primary vaccination in this study.
Eligible participants ≥ 60 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Eligible participants 60-94 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Eligible participants 18 to 49 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Overall Number of Participants Analyzed 25 19 27 26 23 27 25 28 22 28 19 25 24 24 24 29 39 14 35 42
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Baseline Number Analyzed 25 participants 19 participants 27 participants 26 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 19 participants 25 participants 24 participants 24 participants 24 participants 29 participants 39 participants 14 participants 35 participants 42 participants
1030.5
(543.6 to 1953.7)
689.8
(295.3 to 1611.4)
646.2
(354.3 to 1178.4)
620.9
(326.7 to 1180.1)
547.4
(334.5 to 895.6)
539.6
(293.3 to 992.5)
1089.2
(599.9 to 1977.6)
856.1
(471.5 to 1554.3)
749.7
(406.6 to 1382.5)
770.6
(413.5 to 1436.2)
925.3
(366.0 to 2339.3)
777.3
(413.1 to 1462.8)
908.6
(501.0 to 1647.8)
640.4
(378.5 to 1083.5)
160.1
(78.6 to 326.1)
671.5
(432.5 to 1042.4)
769.8
(559.5 to 1059.0)
493.1
(170.7 to 1424.8)
683.8
(460.7 to 1014.9)
851.8
(534.3 to 1357.9)
Day 28 Number Analyzed 25 participants 19 participants 26 participants 26 participants 23 participants 27 participants 25 participants 28 participants 21 participants 28 participants 19 participants 25 participants 24 participants 24 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
975.2
(508.7 to 1869.6)
649.3
(285.2 to 1478.2)
544.9
(297.5 to 998.3)
648.7
(324.3 to 1297.5)
475.4
(284.8 to 793.4)
535.4
(287.5 to 997.1)
1086.1
(613.7 to 1922.0)
839.1
(469.7 to 1499.0)
729.3
(380.1 to 1399.5)
731.0
(382.7 to 1396.2)
932.8
(402.0 to 2164.8)
16822.8
(11052.9 to 25604.9)
21215.2
(15921.0 to 28269.9)
14102.7
(9666.5 to 20574.8)
Day 29 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 24 participants 29 participants 39 participants 14 participants 35 participants 42 participants
10798.6
(7482.3 to 15584.8)
630.6
(407.9 to 974.8)
734.8
(544.2 to 992.1)
694.7
(249.8 to 1931.4)
10862.2
(8363.3 to 14107.7)
8286.7
(6204.3 to 11068.0)
Day 36 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 29 participants 39 participants 14 participants 35 participants 42 participants
6915.9
(4770.3 to 10026.5)
3909.4
(2555.3 to 5981.0)
7407.6
(3545.0 to 15479.0)
10851.2
(8549.3 to 13772.9)
8143.0
(6132.6 to 10812.4)
Day 56 Number Analyzed 25 participants 19 participants 27 participants 26 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 19 participants 25 participants 24 participants 24 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
15032.5
(10033.4 to 22522.2)
12246.2
(7488.7 to 20025.9)
16739.1
(11460.0 to 24450.0)
13673.2
(8411.3 to 22226.9)
12847.2
(9036.9 to 18264.2)
18464.0
(14207.7 to 23995.3)
15242.3
(11298.2 to 20563.2)
15071.0
(9104.8 to 24946.5)
25738.6
(16696.8 to 39676.9)
14709.3
(10110.9 to 21399.2)
12428.4
(6942.7 to 22248.5)
14302.9
(10081.6 to 20291.8)
18086.8
(13594.7 to 24063.2)
11282.4
(8142.8 to 15632.5)
Day 57 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 29 participants 39 participants 14 participants 35 participants 42 participants
10684.3
(8532.4 to 13378.9)
5646.8
(4043.4 to 7886.1)
7944.8
(4570.2 to 13811.2)
9388.2
(7285.3 to 12098.2)
7316.3
(5685.6 to 9414.7)
Day 208 Number Analyzed 25 participants 19 participants 27 participants 26 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 19 participants 25 participants 24 participants 24 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
6015.9
(4271.9 to 8471.9)
4784.5
(3114.9 to 7349.0)
6231.0
(4321.0 to 8985.3)
5675.5
(3783.7 to 8513.4)
4212.3
(3065.0 to 5789.1)
4997.4
(3748.7 to 6662.0)
5577.8
(4072.7 to 7639.2)
6686.7
(4766.4 to 9380.5)
7761.2
(5226.5 to 11525.1)
5274.3
(3746.7 to 7424.6)
4978.7
(3275.4 to 7567.6)
7082.7
(5051.7 to 9930.2)
7469.9
(5874.5 to 9498.6)
5355.9
(4082.7 to 7026.2)
Day 211 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 29 participants 39 participants 14 participants 35 participants 42 participants
5970.0
(4586.1 to 7771.7)
4137.3
(3176.2 to 5389.2)
3745.8
(1975.8 to 7101.5)
5320.5
(4169.4 to 6789.4)
5020.4
(3878.5 to 6498.6)
Year 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 24 participants 26 participants 37 participants 10 participants 32 participants 35 participants
1662.0
(1203.1 to 2296.0)
1804.4
(1405.6 to 2316.4)
1477.4
(1016.3 to 2147.7)
1672.4
(656.0 to 4263.7)
1770.6
(1310.4 to 2392.3)
1635.0
(1194.2 to 2238.4)
Year 3 Number Analyzed 24 participants 19 participants 27 participants 26 participants 23 participants 27 participants 25 participants 28 participants 22 participants 27 participants 19 participants 25 participants 24 participants 24 participants 21 participants 24 participants 35 participants 13 participants 29 participants 37 participants
2229.0
(1481.3 to 3354.1)
1493.3
(987.8 to 2257.6)
2058.7
(1538.0 to 2755.7)
2227.0
(1581.4 to 3136.2)
1465.7
(1056.7 to 2032.8)
1568.0
(1188.6 to 2068.5)
2156.1
(1527.7 to 3042.9)
1913.2
(1386.8 to 2639.4)
2063.1
(1370.8 to 3105.0)
1702.4
(1165.5 to 2486.6)
1579.5
(977.5 to 2552.2)
2422.7
(1732.0 to 3388.9)
2914.8
(2270.4 to 3742.1)
2077.8
(1523.3 to 2834.1)
1500.9
(1031.3 to 2184.2)
2006.4
(1373.3 to 2931.3)
1932.8
(1245.7 to 2998.7)
1254.9
(701.7 to 2244.2)
1670.1
(1258.5 to 2216.4)
1700.5
(1224.7 to 2361.3)
Year 4 Number Analyzed 23 participants 19 participants 26 participants 26 participants 23 participants 26 participants 23 participants 28 participants 22 participants 28 participants 19 participants 25 participants 23 participants 24 participants 20 participants 18 participants 22 participants 11 participants 20 participants 27 participants
2095.5
(1272.0 to 3452.2)
1727.7
(1016.1 to 2937.8)
2541.1
(1618.3 to 3990.1)
1958.2
(1363.0 to 2813.3)
1802.9
(1185.9 to 2740.8)
1565.5
(1181.0 to 2075.1)
2934.1
(1993.0 to 4319.7)
2107.0
(1384.3 to 3207.0)
1965.0
(1287.9 to 2997.9)
1679.0
(1208.0 to 2333.5)
2025.2
(1254.9 to 3268.3)
2335.8
(1724.4 to 3163.8)
2635.7
(1936.2 to 3587.9)
2016.6
(1500.0 to 2711.1)
1627.4
(1127.0 to 2350.1)
1512.1
(1032.5 to 2214.6)
1441.7
(926.9 to 2242.4)
1238.3
(841.5 to 1822.1)
1585.6
(1101.6 to 2282.3)
1392.4
(917.6 to 2112.9)
Year 5 Number Analyzed 21 participants 19 participants 26 participants 24 participants 23 participants 26 participants 24 participants 27 participants 22 participants 25 participants 19 participants 24 participants 21 participants 24 participants 19 participants 8 participants 15 participants 10 participants 10 participants 16 participants
1732.3
(1133.8 to 2646.8)
1563.6
(957.9 to 2552.6)
2345.8
(1566.6 to 3512.7)
2009.8
(1396.6 to 2892.2)
1664.8
(1100.7 to 2518.1)
1781.2
(1102.5 to 2877.7)
2116.5
(1597.7 to 2803.7)
2270.3
(1536.1 to 3355.5)
2181.9
(1360.4 to 3499.2)
1811.9
(1173.5 to 2797.8)
1434.9
(956.9 to 2151.6)
2036.9
(1475.0 to 2812.9)
2405.4
(1763.1 to 3281.8)
1817.7
(1256.1 to 2630.5)
1803.8
(1205.4 to 2699.1)
1937.4
(1141.5 to 3288.2)
1255.5
(709.1 to 2223.1)
1048.6
(566.7 to 1940.4)
2060.5
(1422.7 to 2984.3)
1687.2
(1031.7 to 2759.3)
4.Secondary Outcome
Title Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA
Hide Description GMT of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. Data reported for up to Year 5 was collected at Baseline (NOR-107,NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107,NOR-210, NOR-204).
Time Frame Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study
Hide Outcome Measure Data
Hide Analysis Population Description
PPS included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.
Arm/Group Title NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
Hide Arm/Group Description:
Eligible NOR-107 participants who had received 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 (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.
Eligible participants who received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 in previous study NOR-210 were enrolled at 2nd year post-primary vaccination in this study.
Eligible participants ≥ 60 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Eligible participants 60-94 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Eligible participants 18 to 49 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.
Overall Number of Participants Analyzed 25 19 27 26 23 27 25 28 22 28 19 25 24 24 24 29 39 14 35 42
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Baseline Number Analyzed 25 participants 19 participants 27 participants 26 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 19 participants 25 participants 24 participants 24 participants 24 participants 29 participants 39 participants 14 participants 35 participants 42 participants
1209.8
(617.2 to 2371.5)
1248.3
(665.1 to 2343.0)
1423.3
(799.5 to 2533.7)
954.0
(530.1 to 1716.8)
838.8
(507.6 to 1386.1)
1239.7
(705.8 to 2177.4)
1373.7
(792.4 to 2381.6)
1179.5
(677.5 to 2053.4)
1133.9
(648.4 to 1982.8)
1442.1
(864.3 to 2406.1)
2069.2
(1362.0 to 3143.7)
1078.9
(678.4 to 1715.6)
1308.9
(779.3 to 2198.4)
1598.5
(952.6 to 2682.3)
93.1
(58.8 to 147.3)
1213.2
(658.2 to 2236.1)
826.1
(508.7 to 1341.7)
1288.0
(570.8 to 2906.4)
1263.5
(794.7 to 2009.0)
1149.0
(672.9 to 1961.8)
Day 28 Number Analyzed 25 participants 19 participants 26 participants 26 participants 23 participants 27 participants 25 participants 28 participants 21 participants 28 participants 19 participants 25 participants 24 participants 24 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
1218.3
(609.8 to 2433.7)
1233.2
(658.4 to 2309.7)
1471.1
(841.2 to 2572.7)
953.8
(549.5 to 1655.4)
754.4
(464.2 to 1226.0)
1198.8
(688.3 to 2088.0)
1310.7
(797.3 to 2154.5)
1246.3
(710.3 to 2187.0)
1086.0
(619.5 to 1903.7)
1491.7
(983.7 to 2262.0)
1940.6
(1259.0 to 2991.2)
8866.0
(6415.5 to 12252.6)
13710.2
(10111.0 to 18590.5)
10202.3
(6715.1 to 15500.5)
Day 29 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 24 participants 29 participants 39 participants 14 participants 35 participants 42 participants
10170.0
(7301.6 to 14165.2)
1172.6
(630.4 to 2181.1)
818.6
(510.4 to 1313.0)
1251.3
(563.1 to 2780.5)
9284.7
(6772.0 to 12729.9)
8508.2
(5798.6 to 12484.1)
Day 36 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 29 participants 39 participants 14 participants 35 participants 42 participants
5938.0
(3771.8 to 9348.2)
4248.1
(2787.2 to 6474.8)
8348.3
(5370.9 to 12976.3)
9415.5
(7120.6 to 12450.1)
8518.7
(5970.1 to 12155.2)
Day 56 Number Analyzed 25 participants 19 participants 27 participants 26 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 19 participants 25 participants 24 participants 24 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
5051.3
(3144.0 to 8115.7)
8644.5
(6368.1 to 11734.7)
5651.7
(4159.3 to 7679.4)
3909.2
(2620.5 to 5831.7)
6655.7
(4670.1 to 9485.5)
7585.7
(5687.6 to 10117.3)
3296.3
(2075.7 to 5234.7)
9110.9
(5865.5 to 14152.2)
4762.7
(2918.8 to 7771.4)
10733.0
(7902.0 to 14578.1)
9544.8
(6846.7 to 13306.1)
7083.6
(5125.3 to 9790.1)
10333.3
(7485.5 to 14264.4)
7801.7
(5379.1 to 11315.4)
Day 57 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 29 participants 39 participants 14 participants 35 participants 42 participants
9761.9
(6487.9 to 14688.1)
5961.1
(4365.7 to 8139.7)
8689.8
(6309.5 to 11968.1)
7673.7
(5733.9 to 10269.7)
7610.5
(5336.3 to 10854.0)
Day 208 Number Analyzed 25 participants 19 participants 27 participants 26 participants 23 participants 27 participants 25 participants 28 participants 22 participants 28 participants 19 participants 25 participants 24 participants 24 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
2805.0
(1665.3 to 4724.8)
3797.7
(2654.3 to 5433.8)
2757.9
(1631.0 to 4663.4)
2575.3
(1695.6 to 3911.3)
2861.7
(2000.7 to 4093.2)
3086.6
(2194.7 to 4341.0)
2239.3
(1451.7 to 3454.4)
4668.9
(3069.6 to 7101.4)
2349.9
(1405.2 to 3929.8)
4661.9
(3401.9 to 6388.5)
4450.1
(2994.6 to 6613.0)
4004.2
(2834.4 to 5656.7)
4807.4
(3225.4 to 7165.3)
4177.3
(2914.0 to 5988.2)
Day 211 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 29 participants 39 participants 14 participants 35 participants 42 participants
5710.0
(3654.0 to 8922.7)
3949.0
(2991.2 to 5213.6)
4825.8
(3063.2 to 7602.6)
5389.0
(4070.1 to 7135.2)
5415.4
(3633.4 to 8071.3)
Year 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 24 participants 26 participants 37 participants 10 participants 32 participants 35 participants
1513.3
(897.0 to 2553.2)
2344.8
(1508.6 to 3644.5)
1465.5
(1039.9 to 2065.3)
4160.4
(1968.6 to 8792.4)
2244.0
(1462.9 to 3442.1)
2380.4
(1507.4 to 3759.2)
Year 3 Number Analyzed 24 participants 19 participants 27 participants 26 participants 23 participants 27 participants 25 participants 28 participants 22 participants 27 participants 19 participants 25 participants 24 participants 24 participants 21 participants 24 participants 35 participants 13 participants 29 participants 37 participants
1643.9
(850.8 to 3176.6)
1874.7
(1066.5 to 3295.6)
1756.7
(1193.6 to 2585.3)
1159.4
(731.0 to 1838.7)
1193.5
(780.4 to 1825.4)
1385.2
(946.0 to 2028.2)
1425.3
(844.2 to 2406.6)
1705.3
(1024.2 to 2839.3)
1166.5
(608.1 to 2237.6)
1775.4
(1208.6 to 2608.1)
1783.7
(1093.8 to 2909.0)
1880.8
(1254.3 to 2820.4)
2079.5
(1465.2 to 2951.4)
1946.0
(1303.7 to 2904.8)
1202.9
(682.0 to 2121.6)
2200.3
(1284.6 to 3768.8)
1771.1
(1276.4 to 2457.6)
2155.0
(1293.4 to 3590.8)
2297.5
(1422.8 to 3709.9)
2304.2
(1369.0 to 3878.4)
Year 4 Number Analyzed 23 participants 19 participants 26 participants 26 participants 23 participants 26 participants 23 participants 28 participants 22 participants 28 participants 19 participants 25 participants 23 participants 24 participants 20 participants 18 participants 22 participants 11 participants 20 participants 27 participants
1580.2
(856.2 to 2916.6)
2128.6
(1214.1 to 3732.0)
1828.6
(1183.6 to 2825.2)
1234.2
(791.8 to 1923.6)
1283.8
(870.2 to 1894.0)
1714.5
(1133.1 to 2594.2)
2114.3
(1369.8 to 3263.4)
1858.2
(1107.6 to 3117.5)
1115.2
(597.5 to 2081.7)
1762.5
(1170.1 to 2655.0)
2173.9
(1287.5 to 3670.6)
1702.1
(976.9 to 2965.5)
2766.1
(1630.1 to 4694.0)
2044.1
(1416.3 to 2950.2)
1254.0
(743.5 to 2115.0)
1514.3
(895.9 to 2559.5)
1267.2
(788.9 to 2035.5)
1806.5
(1032.7 to 3160.1)
2466.9
(1489.0 to 4086.9)
1823.5
(1089.5 to 3052.0)
Year 5 Number Analyzed 21 participants 19 participants 26 participants 24 participants 23 participants 26 participants 24 participants 27 participants 22 participants 25 participants 19 participants 24 participants 21 participants 24 participants 19 participants 8 participants 15 participants 10 participants 10 participants 17 participants
1159.9
(587.5 to 2289.8)
2232.6
(1270.8 to 3922.1)
1702.6
(1091.4 to 2656.0)
1135.0
(709.5 to 1815.7)
1177.1
(774.7 to 1788.5)
1545.6
(952.6 to 2507.9)
1410.6
(927.5 to 2145.5)
2047.9
(1097.6 to 3821.1)
1265.5
(682.2 to 2347.3)
2037.4
(1364.0 to 3043.1)
1648.1
(989.0 to 2746.2)
1746.6
(1149.0 to 2655.0)
2225.0
(1305.9 to 3791.0)
1624.0
(1073.2 to 2457.7)
1241.5
(726.4 to 2121.8)
1076.0
(406.2 to 2850.3)
912.7
(529.7 to 1572.6)
1187.7
(680.8 to 2071.8)
1522.7
(936.1 to 2476.8)
2097.3
(1285.7 to 3421.1)
Time Frame From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
Hide Arm/Group Description Eligible NOR-107 participants who had received 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 (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible participants who received 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 aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study. Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible participants who received 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 aluminium hydroxide, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study. Eligible NOR-107 participants who had received 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 MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received 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 aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study. Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study. Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) [15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study. Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
All-Cause Mortality
NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/19 (0.00%)   0/27 (0.00%)   0/27 (0.00%)   0/23 (0.00%)   0/27 (0.00%)   0/25 (0.00%)   0/28 (0.00%)   0/22 (0.00%)   0/28 (0.00%)   0/21 (0.00%)   0/25 (0.00%)   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%)   1/29 (3.45%)   3/39 (7.69%)   0/14 (0.00%)   2/35 (5.71%)   0/42 (0.00%) 
Hide Serious Adverse Events
NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   1/19 (5.26%)   1/27 (3.70%)   1/27 (3.70%)   0/23 (0.00%)   0/27 (0.00%)   0/25 (0.00%)   0/28 (0.00%)   0/22 (0.00%)   0/28 (0.00%)   0/21 (0.00%)   0/25 (0.00%)   0/24 (0.00%)   0/24 (0.00%)   1/24 (4.17%)   2/29 (6.90%)   5/39 (12.82%)   0/14 (0.00%)   2/35 (5.71%)   2/42 (4.76%) 
Cardiac disorders                                         
Arteriosclerosis coronary artery  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/29 (0.00%)  0/39 (0.00%)  0/14 (0.00%)  0/35 (0.00%)  1/42 (2.38%) 
Cardiac failure congestive  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/29 (0.00%)  1/39 (2.56%)  0/14 (0.00%)  0/35 (0.00%)  0/42 (0.00%) 
Coronary artery disease  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/29 (0.00%)  0/39 (0.00%)  0/14 (0.00%)  0/35 (0.00%)  1/42 (2.38%) 
Eye disorders                                         
Amaurosis fugax  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  1/29 (3.45%)  0/39 (0.00%)  0/14 (0.00%)  0/35 (0.00%)  0/42 (0.00%) 
Episcleritis  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  1/24 (4.17%)  0/29 (0.00%)  0/39 (0.00%)  0/14 (0.00%)  0/35 (0.00%)  0/42 (0.00%) 
Gastrointestinal disorders                                         
Colitis ulcerative  1  0/25 (0.00%)  1/19 (5.26%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/29 (0.00%)  0/39 (0.00%)  0/14 (0.00%)  0/35 (0.00%)  0/42 (0.00%) 
Crohn's disease  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/29 (0.00%)  0/39 (0.00%)  0/14 (0.00%)  0/35 (0.00%)  0/42 (0.00%) 
Infections and infestations                                         
Appendicitis  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/29 (0.00%)  1/39 (2.56%)  0/14 (0.00%)  0/35 (0.00%)  0/42 (0.00%) 
Pneumonia  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/29 (0.00%)  0/39 (0.00%)  0/14 (0.00%)  1/35 (2.86%)  0/42 (0.00%) 
Sepsis  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/29 (0.00%)  1/39 (2.56%)  0/14 (0.00%)  0/35 (0.00%)  0/42 (0.00%) 
Injury, poisoning and procedural complications                                         
Fall  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/29 (0.00%)  0/39 (0.00%)  0/14 (0.00%)  0/35 (0.00%)  1/42 (2.38%) 
Subdural haematoma  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/29 (0.00%)  0/39 (0.00%)  0/14 (0.00%)  1/35 (2.86%)  1/42 (2.38%) 
Metabolism and nutrition disorders                                         
Adult failure to thrive  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/29 (0.00%)  0/39 (0.00%)  0/14 (0.00%)  1/35 (2.86%)  0/42 (0.00%) 
Musculoskeletal and connective tissue disorders                                         
Polymyalgia rheumatica  1  0/25 (0.00%)  0/19 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/29 (0.00%)  0/39 (0.00%)  0/14 (0.00%)  0/35 (0.00%)  0/42 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                                         
Metastases to lung  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  1/29 (3.45%)  0/39 (0.00%)  0/14 (0.00%)  0/35 (0.00%)  0/42 (0.00%) 
Metastatic renal cell carcinoma  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  1/29 (3.45%)  0/39 (0.00%)  0/14 (0.00%)  0/35 (0.00%)  0/42 (0.00%) 
Squamous cell carcinoma of the tongue  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/29 (0.00%)  1/39 (2.56%)  0/14 (0.00%)  0/35 (0.00%)  0/42 (0.00%) 
Nervous system disorders                                         
Neurodegenerative disorder  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/29 (0.00%)  1/39 (2.56%)  0/14 (0.00%)  0/35 (0.00%)  0/42 (0.00%) 
Respiratory, thoracic and mediastinal disorders                                         
Pulmonary embolism  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/29 (0.00%)  1/39 (2.56%)  0/14 (0.00%)  0/35 (0.00%)  0/42 (0.00%) 
Respiratory failure  1  0/25 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/23 (0.00%)  0/27 (0.00%)  0/25 (0.00%)  0/28 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/21 (0.00%)  0/25 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/29 (0.00%)  0/39 (0.00%)  0/14 (0.00%)  1/35 (2.86%)  0/42 (0.00%) 
1
Term from vocabulary, MedDRA24.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/19 (0.00%)   0/27 (0.00%)   0/27 (0.00%)   0/23 (0.00%)   0/27 (0.00%)   0/25 (0.00%)   0/28 (0.00%)   0/22 (0.00%)   0/28 (0.00%)   0/21 (0.00%)   0/25 (0.00%)   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%)   0/29 (0.00%)   0/39 (0.00%)   0/14 (0.00%)   0/35 (0.00%)   0/42 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Takeda (Note: This product was divested to HilleVax in 2022)
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03039790    
Other Study ID Numbers: NOR-213
2016-004288-37 ( EudraCT Number )
U1111-1189-7907 ( Registry Identifier: WHO )
First Submitted: January 31, 2017
First Posted: February 1, 2017
Results First Submitted: July 21, 2022
Results First Posted: October 6, 2022
Last Update Posted: November 9, 2022