Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults
NCT ID: NCT03039790
Last Updated: 2022-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
528 participants
INTERVENTIONAL
2017-02-21
2021-07-22
Brief Summary
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Detailed Description
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The drug being tested in this study is called NoV vaccine. NoV vaccine is being tested for protection against acute gastroenteritis (AGE) due to norovirus.
The study will enroll maximum of approximately 575 participants. Participants who previously received NoV vaccine in studies NOR-107, NOR-210 and NOR-204 will be enrolled. Participants from study NOR-107 will enter the study at the time of their 3rd year post-primary vaccination, and from studies NOR-210 and NOR-204, at their 2nd year post-primary vaccination. The duration of participation in the study will be different for each participant.
This multi-center trial will be conducted in Belgium and the United States. The overall time to participate in this study is maximum 5 years after primary NoV vaccination. Participants will have a maximum of 4 visits over 3 years
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose
Eligible participants who 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 (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.
NoV Vaccine
NoV vaccine injection administered.
NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 yrs)
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 yrs)
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose
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.
NoV Vaccine
NoV vaccine injection administered.
Interventions
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NoV Vaccine
NoV vaccine injection administered.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. In the opinion of the investigator, the participant is not medically eligible to provide blood specimens.
3. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the trial.
18 Years
ALL
Yes
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Simon-Williamson Clinic/Synexus Clinical Research US, Inc
Birmingham, Alabama, United States
Synexus Clinical Research US, Inc./Fountain Hills Family Practice, P.C.
Fountain Hills, Arizona, United States
Synexus Clinical Research US, Inc/Southwest Family Medicine
Littleton, Colorado, United States
Miami Research Associates
Miami, Florida, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
St. Louis University, School of Medicine
St Louis, Missouri, United States
Regional Clinical Research Inc.
Endwell, New York, United States
University of Rochester
Rochester, New York, United States
Benchmark Research Austin
Austin, Texas, United States
Universiteit Antwerpen
Antwerp, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-004288-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1189-7907
Identifier Type: REGISTRY
Identifier Source: secondary_id
NOR-213
Identifier Type: -
Identifier Source: org_study_id
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