NorovirusPhase 2NCT02475278
Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
A Phase 2 study testing NoV GI.1/GII.4 Bivalent VLP Vaccine in people with Norovirus and Healthy Participants, run by Takeda at 1 site in United States.
Trial summary
The purpose of this study is to collect serum samples to evaluate serologic assays and to establish proficiency panels for serologic assays used for assessment of post vaccination immune response after intramuscular (IM) vaccination with Norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Norovirus, Healthy Participants
- What is being tested?
- NoV GI.1/GII.4 Bivalent VLP Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2015to 9 Sep 2015
- 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 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 49 years, inclusive.
- Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.
- Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
- Can comply with trial procedures and are available for the duration of follow-up.
- Body weight of ≥50kg (110lbs).
- Body mass index (BMI) <35.
Who cannot join
- Has a history of acute gastroenteritis (AGE) within 14 days of enrollment.
- Has previously been exposed to an experimental Norovirus (NoV) Vaccine.
- Has received any inactivated vaccines within 14 days or any live vaccines for 28 days prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of investigational vaccine administration.
- Has contraindications, warnings and/or precautions to vaccination with the NoV Vaccine as specified within the investigator brochure.
- Has known hypersensitivity or allergy to any of the NoV Vaccine components (including excipients).
- Has 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.
Show all 31Show fewer
- Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g. Guillain-Barré syndrome).
- Has history or any illness that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial.
- Has known or suspected impairment/alteration of immune function, including:
- Chronic use of oral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks / ≥ 2 mg/kg body weight / day prednisone ≥ 2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
- Receipt of parenteral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks / ≥ 2 mg/kg body weight / day prednisone ≥ 2 weeks) within 60 days prior to Day 1.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the investigational vaccine or planned administration during the trial (consider whether applicable as an exclusion criterion or criterion for delay).
- Receipt of immunostimulants within 60 days prior to Day 1.
- Receipt of parenteral, epidural or intra-articular immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Day 1 or planned during the full length of the trial.
- Human immunodeficiency virus (HIV) infection or HIV-related disease.
- Genetic immunodeficiency.
- Has abnormalities of splenic or thymic function.
- Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Has any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
- Is participating in any clinical trial with another investigational product 30 days prior to first trial visit or intent to participate in another clinical trial at any time during the conduct of this trial.
- Is involved in the trial conduct or their first degree relatives.
- Has history of substance or alcohol abuse within the past 2 years.
- Females who are pregnant or breastfeeding.
- If female of childbearing potential, sexually active, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to trial entry:
- Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
- Acceptable birth control methods are defined as one or more of the following:
- Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring).
- Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse.
- Intrauterine device (IUD). iv. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the participants' trial entry.
- If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" through to 6 months after receipt of investigational vaccine. In addition, they must be advised not to donate ova during this period.
- Any positive or indeterminate pregnancy test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II, Single Arm, Open Label Trial for Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
The purpose of this study is to collect serum samples to evaluate serologic assays and to establish proficiency panels for serologic assays used for assessment of post vaccination immune response after intramuscular (IM) vaccination with Norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine.
Read the detailed description
The vaccine being tested in this study is called Norovirus GI.1/GII.4 bivalent Virus-Like Particle Vaccine (NoV Vaccine). The purpose of this study is to collect serum samples to evaluate serologic assays and to establish proficiency panels for serologic assays used for assessment of post vaccination immune response after intramuscular (IM) vaccination with the NoV vaccine. The validation and proficiency testing of the immunogenicity assays is required to support the NoV Vaccine development program. This study also looked at side effects in people who were administered a single dose of the NoV vaccine.
The study enrolled 50 patients. All participants received one dose of the NoV vaccine via intramuscular injection.
Participants were asked to record any symptoms that may be related to the vaccine or the injection site in a diary card for 7 days after receiving the vaccination.
This single-centre trial was conducted in the United States. The overall time to participate in this study was 183 days. Participants made 4 visits to the clinic, and were contacted by telephone 183 days after last dose of study drug for a follow-up assessment.
- Conditions
- Norovirus, Healthy Participants
- Being tested
- NoV GI.1/GII.4 Bivalent VLP Vaccine
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoV GI.1/GII.4 Bivalent VLP VaccineBiological
Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide for IM injection
| Study group | Role | What they receive |
|---|---|---|
| NoV Vaccine | Experimental | Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1. Receives: Biological: NoV GI.1/GII.4 Bivalent VLP Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Serum Samples Obtained on Day 8 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies
Serum samples were obtained for assay validation of the pan-Ig enzyme-linked immuno-sorbent assay (ELISA) and the histoblood group antigen (HBGA) binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 8 are reported.
Measured: Day 8
Number of Participants With Serum Samples Obtained on Day 15 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies
Serum samples were obtained to establish proficiency panels for the pan-Ig ELISA and the HBGA binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 15 are reported.
Measured: Day 15
Number of Participants With Serum Samples Obtained on Day 29 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies
Serum samples were obtained to establish proficiency panels for the pan-Ig ELISA and the HBGA binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 29 are reported.
Measured: Day 29
Secondary outcomes (5)
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Maximum Severity
Safety assessment included collection of solicited local AEs for 7 days following vaccination (including the day of vaccination) by using diary cards. Solicited local injection site AEs are defined as pain, erythema (redness), induration and swelling. Pain is summarized as either none or any, where 'any' will be broken down into the following severity categories: mild, moderate, severe. Erythema, swelling and induration are recorded as yes or no, where the definition of 'yes' is any area ≥2.5 cm; and 'yes' is further broken down into the following severity categories: ≥2.5 cm - ≤5.0 cm (mild intensity), >5.0 cm - ≤ 10.0 cm (moderate intensity), >10.0 cm severe intensity). Injection site AEs are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.
Measured: Days 1 through 7
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Maximum Severity
Safety assessment included collection of solicited systemic AEs for 7 days following vaccination (including the day of vaccination) by using diary cards. Solicited systemic AEs are defined as headache, fatigue, myalgia, arthralgia, vomiting and diarrhea and are summarized as either none or any, where 'any' will be broken down into the following severity categories: mild, moderate, severe. Solicited systemic AEs are presented as the percentage of participants experiencing a solicited systemic AE, by AE, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.
Measured: Days 1 through 7
Percentage of Participants With Elevated Daily Oral Temperature
Safety assessment included measurement of body temperature for 7 days following vaccination (including the day of vaccination) by using diary cards. Participants recorded the highest body temperature observed each day in a daily diary. The highest body temperature measurement per participant across Day 1 to Day 7 was categorized as fever present (≥100.4ºF, ≥38ºC) or fever absent (<100.4ºF, <38ºC).
Measured: Days 1 to 7 days after vaccination
Percentage of Participants With Unsolicited Adverse Events (AEs) by Maximum Severity
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. Unsolicited AEs are presented as the percentage of participants experiencing at least one AE, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.
Measured: Days 1 through 28
Percentage of Participants Experiencing Serious Adverse Events
A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Measured: Day 1 up to Day 183
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study start26 Feb 2015
- Primary completion7 Apr 2015
- Study completion9 Sep 2015
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NorovirusStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475278
- Sponsor's protocol ID
- NOR-210
- Other IDs
- U1111-1165-3548
- Status last verified
- Feb 2018
- First submitted
- 24 Feb 2015
- Last updated
- 22 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Atmar RL, Ettayebi K, Neill FH, Braun RP, Sherwood J, Ramani S, Estes MK. Correlation of Genogroup I, Genotype 1 (GI.1) Norovirus Neutralizing Antibody Levels With GI.1 Histo-Blood Group Antigen-Blocking Antibody Levels. J Infect Dis. 2024 Dec 16;230(6):1376-1379. doi: 10.1093/infdis/jiae311.
PubMed 38864524Atmar RL, Ettayebi K, Ayyar BV, Neill FH, Braun RP, Ramani S, Estes MK. Comparison of Microneutralization and Histo-Blood Group Antigen-Blocking Assays for Functional Norovirus Antibody Detection. J Infect Dis. 2020 Feb 18;221(5):739-743. doi: 10.1093/infdis/jiz526.
PubMed 31613328Atmar RL, Cramer JP, Baehner F, Han C, Borkowski A, Mendelman PM. An Exploratory Study of the Salivary Immunoglobulin A Responses to 1 Dose of a Norovirus Virus-Like Particle Candidate Vaccine in Healthy Adults. J Infect Dis. 2019 Jan 9;219(3):410-414. doi: 10.1093/infdis/jiy529.
PubMed 30203081
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Single Arm, Open Label Trial for Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
- ClinicalTrials.gov ID
- NCT02475278
- Acronym / sponsor ID
- NOR-210
- Conditions
- Norovirus, Healthy Participants
- Keywords
- Drug therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2015 (actual)
- Primary completion
- 7 Apr 2015 (actual)
- Study completion
- 9 Sep 2015 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Posted 28 Oct 2016
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 collect serum samples to evaluate serologic assays and to establish proficiency panels for serologic assays used for assessment of post vaccination immune response after intramuscular (IM) vaccination with Norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine.
Detailed description
The vaccine being tested in this study is called Norovirus GI.1/GII.4 bivalent Virus-Like Particle Vaccine (NoV Vaccine). The purpose of this study is to collect serum samples to evaluate serologic assays and to establish proficiency panels for serologic assays used for assessment of post vaccination immune response after intramuscular (IM) vaccination with the NoV vaccine. The validation and proficiency testing of the immunogenicity assays is required to support the NoV Vaccine development program. This study also looked at side effects in people who were administered a single dose of the NoV vaccine.
The study enrolled 50 patients. All participants received one dose of the NoV vaccine via intramuscular injection.
Participants were asked to record any symptoms that may be related to the vaccine or the injection site in a diary card for 7 days after receiving the vaccination.
This single-centre trial was conducted in the United States. The overall time to participate in this study was 183 days. Participants made 4 visits to the clinic, and were contacted by telephone 183 days after last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NoV Vaccine | Experimental | Biological: NoV GI.1/GII.4 Bivalent VLP VaccineNorovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 to 49 years, inclusive.
- Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.
- Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
- Can comply with trial procedures and are available for the duration of follow-up.
- Body weight of ≥50kg (110lbs).
Key exclusion criteria (31 listed)
- Has a history of acute gastroenteritis (AGE) within 14 days of enrollment.
- Has previously been exposed to an experimental Norovirus (NoV) Vaccine.
- Has received any inactivated vaccines within 14 days or any live vaccines for 28 days prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of investigational vaccine administration.
- Has contraindications, warnings and/or precautions to vaccination with the NoV Vaccine as specified within the investigator brochure.
- Has known hypersensitivity or allergy to any of the NoV Vaccine components (including excipients).
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 GI.1/GII.4 Bivalent VLP VaccineNorovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide for IM injection | Biological | NoV Vaccine |
Primary outcome
Number of Participants With Serum Samples Obtained on Day 8 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies
Time frame: Day 8
Serum samples were obtained for assay validation of the pan-Ig enzyme-linked immuno-sorbent assay (ELISA) and the histoblood group antigen (HBGA) binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 8 are reported.
Number of Participants With Serum Samples Obtained on Day 15 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies
Time frame: Day 15
Serum samples were obtained to establish proficiency panels for the pan-Ig ELISA and the HBGA binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 15 are reported.
Number of Participants With Serum Samples Obtained on Day 29 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies
Time frame: Day 29
Serum samples were obtained to establish proficiency panels for the pan-Ig ELISA and the HBGA binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 29 are reported.
5 secondary outcomes
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Maximum Severity
Time frame: Days 1 through 7
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Maximum Severity
Time frame: Days 1 through 7
Percentage of Participants With Elevated Daily Oral Temperature
Time frame: Days 1 to 7 days after vaccination
Percentage of Participants With Unsolicited Adverse Events (AEs) by Maximum Severity
Time frame: Days 1 through 28
Percentage of Participants Experiencing Serious Adverse Events
Time frame: Day 1 up to Day 183
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38864524Atmar RL, Ettayebi K, Neill FH, Braun RP, Sherwood J, Ramani S, Estes MK. Correlation of Genogroup I, Genotype 1 (GI.1) Norovirus Neutralizing Antibody Levels With GI.1 Histo-Blood Group Antigen-Blocking Antibody Levels. J Infect Dis. 2024 Dec 16;230(6):1376-1379. doi: 10.1093/infdis/jiae311.
- Derived from this study: PubMed 31613328Atmar RL, Ettayebi K, Ayyar BV, Neill FH, Braun RP, Ramani S, Estes MK. Comparison of Microneutralization and Histo-Blood Group Antigen-Blocking Assays for Functional Norovirus Antibody Detection. J Infect Dis. 2020 Feb 18;221(5):739-743. doi: 10.1093/infdis/jiz526.
- Derived from this study: PubMed 30203081Atmar RL, Cramer JP, Baehner F, Han C, Borkowski A, Mendelman PM. An Exploratory Study of the Salivary Immunoglobulin A Responses to 1 Dose of a Norovirus Virus-Like Particle Candidate Vaccine in Healthy Adults. J Infect Dis. 2019 Jan 9;219(3):410-414. doi: 10.1093/infdis/jiy529.
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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 Clinical Science study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NoV GI.1/GII.4 Bivalent VLP Vaccine in people with Norovirus and Healthy Participants, run by Takeda at 1 site in United States.
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 6 inclusion and 31 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 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 28 Oct 2016). 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?
Number of Participants With Serum Samples Obtained on Day 8 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies (time frame: Day 8). The study lists 3 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 NCT02475278, which also lists 3 linked publications.
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 22 Feb 2018.