Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults
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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:
Takeda
Information provided by (Responsible Party):
Takeda
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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.
|
Baseline Characteristics
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 | |
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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 | |
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Full Analysis Set (FAS) included all participants with data from at least 1 follow-up time point.
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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%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | Study Director |
Organization: | Takeda (Note: This product was divested to HilleVax in 2022) |
Phone: | +1-877-825-3327 |
EMail: | trialdisclosures@takeda.com |
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 |