Trial · NCT02669121
Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults
NCT02669121, Phase 2, Completed, Takeda; results first posted 2021-06-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults. Trials, record NCT02669121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02669121
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults
- NCT number
- NCT02669121
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 4,748 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Healthy Volunteers
- Interventions
- NoV Placebo-matching Saline, NoV GI.1/GII.4 Bivalent VLP Vaccine
- First posted
- 2016-01-29
- Last updated
- 2021-06-10
- Results first posted
- 2021-06-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Moderate or Severe Acute Gastroenteritis (AGE) Occurring for >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Excluding Co-infection) | Up to Day 47 | Acute gastroenteritis (AGE) is a sudden inflammation or swelling in the lining of the stomach causing diarrhea and vomiting. A norovirus AGE case was defined as meeting the work-up definition plus a norovirus positive stool sample or vomitus sample confirmed by reverse transcriptase polymerase chain reaction (RT-PCR). The severity of AGE was graded by the investigator as per CTCAE criteria. AGE occurring due to NoV strains excluding co-infection with Salmonella, Shigella or Campylobacter is reported. The Norovirus strains included: GI.1, GI.7a, GII.2 and GII.4. |
| Secondary | Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any Norovirus Strain (Excluding Co-infection) | Up to Day 47 | Acute gastroenteritis (AGE) is a sudden inflammation or swelling in the lining of the stomach causing diarrhea and vomiting. A norovirus AGE case was defined as meeting the work-up definition plus a norovirus positive stool sample or vomitus sample confirmed by RT-PCR. The severity of AGE was graded by the investigator as per CTCAE criteria. AGE occurring due to NoV strains excluding co-infection with Salmonella, Shigella or Campylobacter is reported. The Norovirus strains included: GI.1, GI.7a, GII.2 and GII.4. |
| Secondary | Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any Norovirus Strain (Including Co-infection) | Up to Day 47 | Acute gastroenteritis (AGE) is a sudden inflammation or swelling in the lining of the stomach causing diarrhea and vomiting. A norovirus AGE case was defined as meeting the work-up definition plus a norovirus positive stool sample or vomitus sample confirmed by RT-PCR. The severity of AGE was graded by the investigator as per CTCAE criteria. AGE occurring due to NoV strains including co-infection with Salmonella, Shigella or Campylobacter is reported. The Norovirus strains included: GI.1, GI.7a, GII.2 and GII.4. |
| Secondary | Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Including Co-infection) | Up to Day 47 | Acute gastroenteritis (AGE) is a sudden inflammation or swelling in the lining of the stomach causing diarrhea and vomiting. A norovirus AGE case was defined as meeting the work-up definition plus a norovirus positive stool sample or vomitus sample confirmed by RT-PCR. The severity of AGE was graded by the investigator as per CTCAE criteria. AGE occurring due to NoV strains including co-infection with Salmonella, Shigella or Campylobacter is reported. The Norovirus strains included: GI.1, GI.7a, GII.2 and GII.4. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Moderate or Severe Acute Gastroenteritis (AGE) Occurring for >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Excluding Co-infection) | Up to Day 47 | Full Analysis Set included all participants who were randomized and received the trial dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any Norovirus Strain (Excluding Co-infection) | Up to Day 47 | Full Analysis Set included all participants who were randomized and received the trial dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any Norovirus Strain (Including Co-infection) | Up to Day 47 | Full Analysis Set included all participants who were randomized and received the trial dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Including Co-infection) | Up to Day 47 | Full Analysis Set included all participants who were randomized and received the trial dose. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Moderate or Severe Acute Gastroenteritis (AGE) Occurring for >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Excluding Co-infection) | Placebo | 5 | Participants | ||
| Number of Participants With Moderate or Severe Acute Gastroenteritis (AGE) Occurring for >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Excluding Co-infection) | NoV GI.1/GII.4 Bivalent VLP Vaccine | 1 | Participants | ||
| Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any Norovirus Strain (Excluding Co-infection) | Placebo | 26 | Participants | ||
| Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any Norovirus Strain (Excluding Co-infection) | NoV GI.1/GII.4 Bivalent VLP Vaccine | 10 | Participants | ||
| Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any Norovirus Strain (Including Co-infection) | Placebo | 26 | Participants | ||
| Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any Norovirus Strain (Including Co-infection) | NoV GI.1/GII.4 Bivalent VLP Vaccine | 10 | Participants | ||
| Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Including Co-infection) | Placebo | 5 | Participants | ||
| Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Including Co-infection) | NoV GI.1/GII.4 Bivalent VLP Vaccine | 1 | Participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 2,377 | |
| Overall Study | STARTED | NoV GI.1/GII.4 Bivalent VLP Vaccine | 2,371 | |
| Overall Study | Treated (Safety Analysis Set) | Placebo | 2,357 | |
| Overall Study | Treated (Safety Analysis Set) | NoV GI.1/GII.4 Bivalent VLP Vaccine | 2,355 | |
| Overall Study | COMPLETED | Placebo | 2,087 | |
| Overall Study | COMPLETED | NoV GI.1/GII.4 Bivalent VLP Vaccine | 2,089 | |
| Overall Study | NOT COMPLETED | Placebo | 290 | |
| Overall Study | NOT COMPLETED | NoV GI.1/GII.4 Bivalent VLP Vaccine | 282 |
Source ClinicalTrials.gov
Adverse events96
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 45 | 2,357 | |
| other | Upper respiratory tract infection | Infections and infestations | NoV GI.1/GII.4 Bivalent VLP Vaccine | 57 | 2,355 | |
| other | Procedural pain | Injury, poisoning and procedural complications | Placebo | 57 | 2,357 | |
| other | Procedural pain | Injury, poisoning and procedural complications | NoV GI.1/GII.4 Bivalent VLP Vaccine | 55 | 2,355 | |
| serious | Microcytic anaemia | Blood and lymphatic system disorders | Placebo | 1 | 2,357 | |
| serious | Microcytic anaemia | Blood and lymphatic system disorders | NoV GI.1/GII.4 Bivalent VLP Vaccine | 0 | 2,355 | |
| serious | Pancytopenia | Blood and lymphatic system disorders | Placebo | 0 | 2,357 | |
| serious | Pancytopenia | Blood and lymphatic system disorders | NoV GI.1/GII.4 Bivalent VLP Vaccine | 1 | 2,355 | |
| serious | Constipation | Gastrointestinal disorders | Placebo | 1 | 2,357 | |
| serious | Constipation | Gastrointestinal disorders | NoV GI.1/GII.4 Bivalent VLP Vaccine | 0 | 2,355 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 2,357 |
| Total, all-cause mortality | NoV GI.1/GII.4 Bivalent VLP Vaccine | 0 | 2,355 |
| Total, other adverse events | Placebo | 88 | 2,357 |
| Total, other adverse events | NoV GI.1/GII.4 Bivalent VLP Vaccine | 98 | 2,355 |
| Total, serious adverse events | Placebo | 35 | 2,357 |
| Total, serious adverse events | NoV GI.1/GII.4 Bivalent VLP Vaccine | 29 | 2,355 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
NoV GI.1/GII.4 Bivalent VLP Vaccine vs Placebo: Number of Participants With Moderate or Severe Acute Gastroenteritis (AGE) Occurring for >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Excluding Co-infection) | Trial comparisons |
| NoV GI.1/GII.4 Bivalent VLP Vaccine vs Placebo: Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any Norovirus Strain (Excluding Co-infection) | Trial comparisons |
| NoV GI.1/GII.4 Bivalent VLP Vaccine vs Placebo: Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any Norovirus Strain (Including Co-infection) | Trial comparisons |
| NoV GI.1/GII.4 Bivalent VLP Vaccine vs Placebo: Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Including Co-infection) | Trial comparisons |
| NoV GI.1/GII.4 Bivalent VLP Vaccine vs Placebo: deaths from any cause | Trial comparisons |
| NoV GI.1/GII.4 Bivalent VLP Vaccine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02669121
GET https://conductscience.org/api/trials/v1/NCT02669121/events?page=2