Healthy VolunteersPhase 2NCT03039790

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

A Phase 2 study testing NoV Vaccine in people with Healthy Volunteers and Norovirus, run by Takeda at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate descriptively the long-term immunogenicity of at least 1 NoV vaccine administration. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers, Norovirus
What is being tested?: NoV Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 528 participants
Where: 11 sitesin 2 countries
Study dates: 21 Feb 2017to 22 Jul 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1. Male and female participants who previously received at least 1 dose of NoV vaccine in trials NOR-107 (NCT02038907), NOR-210 (NCT02475278) and NOR-204 (NCT02661490), have baseline and post-vaccination data, and completed the primary vaccination trial protocol as initially described.

Who cannot join

Participation in any clinical trial is allowed, on condition that no investigational product is administered within 30 days prior to blood sampling.
In the opinion of the investigator, the participant is not medically eligible to provide blood specimens.
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.

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

United States9 sites

Benchmark Research Austin
Austin, Texas, 78705
Simon-Williamson Clinic/Synexus Clinical Research US, Inc
Birmingham, Alabama, 35211
Regional Clinical Research Inc.
Endwell, New York, 13760
Synexus Clinical Research US, Inc./Fountain Hills Family Practice, P.C.
Fountain Hills, Arizona, 85268
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Synexus Clinical Research US, Inc/Southwest Family Medicine
Littleton, Colorado, 80127
Miami Research Associates
Miami, Florida, 33143
University of Rochester
Rochester, New York, 14642
St. Louis University, School of Medicine
St Louis, Missouri, 63106

Other trials in United States

Belgium2 sites

Universiteit Antwerpen
Antwerp, 2610
Universitair Ziekenhuis Gent
Ghent, 9000

Other trials in Belgium

About this study

Official title: A Phase 2, Long-Term Immunogenicity Follow-up Trial of Adult and Elderly Subjects Who Have Previously Received an Intramuscular Injection of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine

The purpose of this study is to evaluate descriptively the long-term immunogenicity of at least 1 NoV vaccine administration.

Read the detailed description

Results prepared and posted by Takeda on behalf of Hillevax, the IND holder.

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: Healthy Volunteers, Norovirus
Being tested: NoV Vaccine
Keywords: Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NoV VaccineBiological
NoV vaccine injection administered.

Study groups in NCT03039790
Study group	Role	What they receive
NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 yrs)	Experimental	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. Receives: Biological: NoV Vaccine
NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 yrs)	Experimental	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. Receives: Biological: NoV Vaccine
NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose	Experimental	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. Receives: Biological: NoV Vaccine
NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose	Experimental	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. Receives: Biological: NoV Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay
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)
Measured: 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
Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay
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) .
Measured: 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

Secondary outcomes (2)

Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)
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).
Measured: 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
Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA
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).
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Feb 201722 Jul 2021

First posted1 Feb 2017 (estimated)
Study start21 Feb 2017
Primary completion22 Jul 2021
Study completion22 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 528 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03039790
Sponsor's protocol ID: NOR-213
Other IDs: 2016-004288-37, U1111-1189-7907, 2016
Status last verified: Nov 2022
First submitted: 31 Jan 2017
Last updated: 9 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Long-Term Immunogenicity Follow-up Trial of Adult and Elderly Subjects Who Have Previously Received an Intramuscular Injection of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
ClinicalTrials.gov ID: NCT03039790
Acronym / sponsor ID: NOR-213
Conditions: Healthy Volunteers, Norovirus
Keywords: Drug Therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 528 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 21 Feb 2017 (actual)
Primary completion: 22 Jul 2021 (actual)
Study completion: 22 Jul 2021 (actual)
First posted: 1 Feb 2017 (estimated)
Results: Posted 6 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate descriptively the long-term immunogenicity of at least 1 NoV vaccine administration.

Detailed description

Results prepared and posted by Takeda on behalf of Hillevax, the IND holder.

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.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 20

Arm	Type	Receives
NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 yrs)	Experimental	Biological: NoV VaccineEligible 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.
NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 yrs)	Experimental	Biological: NoV VaccineEligible 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.
NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose	Experimental	Biological: NoV VaccineEligible 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.
NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose	Experimental	Biological: NoV VaccineEligible 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

1. Male and female participants who previously received at least 1 dose of NoV vaccine in trials NOR-107 (NCT02038907), NOR-210 (NCT02475278) and NOR-204 (NCT02661490), have baseline and post-vaccination data, and completed the primary vaccination trial protocol as initially described.

Key exclusion criteria (3 listed)

Participation in any clinical trial is allowed, on condition that no investigational product is administered within 30 days prior to blood sampling.
In the opinion of the investigator, the participant is not medically eligible to provide blood specimens.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NoV VaccineNoV vaccine injection administered.	Biological	NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose, NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose, NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose, NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose, NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose, NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose, NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose, NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose, NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose, NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose, NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose, NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose, NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose, NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 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 - MPL 15 µg, 2-Dose, 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, 1-Dose (Age: 60-94 yrs), NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose, NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose

Primary outcome

Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay
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
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)
Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay
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
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) .

2 secondary outcomes

Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)
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
Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA
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

Results and safety

Results posted to the registry on 6 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose	25	21
NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose	19	19
NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose	27	26
NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose	27	25
NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose	23	23
NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose	27	26
NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose	25	24
NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose	28	27
NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose	22	22
NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose	28	26
NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose	21	20
NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose	25	25
NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose	24	21
NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose	24	24
NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose	24	20
NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose	29	22
NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs)	39	29
NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs)	14	12
NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose	35	29
NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose	42	34

Primary outcome: Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay

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. Geometric mean (95% Confidence Interval). Unit: titer

Measure	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose n = 25	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose n = 19	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose n = 27	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose n = 26	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose n = 23	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose n = 27	NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose n = 25	NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose n = 28	NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose n = 22	NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose n = 28	NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose n = 19	NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose n = 25	NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose n = 24	NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose n = 24	NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose n = 24	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose n = 29	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) n = 39	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) n = 14	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose n = 35	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose n = 42
Baseline	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)

Population analysed: 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.

Primary outcome: Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay

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. Geometric mean (95% Confidence Interval). Unit: titer

Measure	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose n = 25	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose n = 19	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose n = 27	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose n = 26	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose n = 23	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose n = 27	NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose n = 25	NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose n = 28	NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose n = 22	NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose n = 28	NOR-107: GI.1/GII.4 (15/15/167) μg,1-Dose n = 19	NOR-107: GI.1/GII.4 (50/50/500) μg,2-Dose n = 25	NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose n = 24	NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose n = 24	NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose n = 24	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose n = 29	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) n = 39	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) n = 14	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose n = 35	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose n = 42
Baseline	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)

2 secondary outcomes are reported in the full results.

Adverse events

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). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose	0 of 25 (0%)	0 of 25 (0%)	0 of 25
NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose	1 of 19 (5.3%)	0 of 19 (0%)	0 of 19
NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose	1 of 27 (3.7%)	0 of 27 (0%)	0 of 27
NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose	1 of 27 (3.7%)	0 of 27 (0%)	0 of 27
NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose	0 of 23 (0%)	0 of 23 (0%)	0 of 23
NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose	0 of 27 (0%)	0 of 27 (0%)	0 of 27
NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose	0 of 25 (0%)	0 of 25 (0%)	0 of 25
NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose	0 of 28 (0%)	0 of 28 (0%)	0 of 28
NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose	0 of 22 (0%)	0 of 22 (0%)	0 of 22
NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose	0 of 28 (0%)	0 of 28 (0%)	0 of 28
NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose	0 of 21 (0%)	0 of 21 (0%)	0 of 21
NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose	0 of 25 (0%)	0 of 25 (0%)	0 of 25
NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose	0 of 24 (0%)	0 of 24 (0%)	0 of 24
NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose	0 of 24 (0%)	0 of 24 (0%)	0 of 24
NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose	1 of 24 (4.2%)	0 of 24 (0%)	0 of 24
NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose	2 of 29 (6.9%)	0 of 29 (0%)	1 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Takeda

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NoV Vaccine in people with Healthy Volunteers and Norovirus, run by Takeda at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03039790.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.