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NCT02669121 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults
A Phase 2 study of Healthy Volunteers, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 4,748
- Enrollment target
- 1
- Study location
NCT02669121: Completed Phase 2 study of Healthy Volunteers, sponsored by Takeda.
NCT02669121 is a Phase 2 study of Healthy Volunteers that has completed, run by Takeda. The registered enrollment target is 4,748 participants, above the 465-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (921% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02669121, a Phase 2 study of Healthy Volunteers, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 4,748 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the efficacy of the Norovirus (NoV) GI.1/GII.4 bivalent virus-like particle vaccine against moderate or severe acute gastroenteritis (AGE) due to genotype-specific (GI.1 and GII.4) NoV strains.
Primary Outcome
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 repo
Conditions Studied
Interventions
- BIOLOGICAL NoV Placebo-matching Saline
- BIOLOGICAL NoV GI.1/GII.4 Bivalent VLP Vaccine
Study Locations (1)
Illinois
- Great Lakes Naval Station - Great Lakes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,748 participants |
| Start Date | 2016-06-14 |
| Est. Completion | 2018-06-16 |
| Phase | Phase 2 |
What the finished NCT02669121 record still lists
NCT02669121 is an interventional study that assigns participants to a tested intervention. Its 4,748 participants enrollment target places it among the larger protocols in the corpus, above the 465-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (921% higher).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which NoV Placebo-matching Saline is the first listed.
NCT02669121 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT02669121 about?
NCT02669121 is a clinical study titled "Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults". The purpose of this study is to evaluate the efficacy of the Norovirus (NoV) GI.1/GII.4 bivalent virus-like particle vaccine against moderate or severe acute gastroenteritis (AGE) due to genotype-specific (GI.1 and GII.4) NoV strains.
What is the current status of trial NCT02669121?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 4,748 participants. The study started on 2016-06-14. Estimated completion is 2018-06-16.
What conditions does trial NCT02669121 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT02669121?
The interventions under investigation include: NoV Placebo-matching Saline (BIOLOGICAL), NoV GI.1/GII.4 Bivalent VLP Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02669121?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02669121 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02669121's enrollment target sits among peer trials
4,748 6th of 283 higher than 278 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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