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NCT02475278 · ClinicalTrials.gov registry record · Phase 2
Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
A Phase 2 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT02475278: Completed Phase 2 study, sponsored by Takeda.
NCT02475278 is a Phase 2 study that has completed, run by Takeda. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02475278, a Phase 2 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BIOLOGICAL NoV GI.1/GII.4 Bivalent VLP Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2015-02-26 |
| Est. Completion | 2015-09-09 |
| Phase | Phase 2 |
What the finished NCT02475278 record still lists
NCT02475278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which NoV GI.1/GII.4 Bivalent VLP Vaccine is the first listed.
NCT02475278 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02475278 about?
NCT02475278 is a clinical study titled "Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of 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) vaccin...
What is the current status of trial NCT02475278?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2015-02-26. Estimated completion is 2015-09-09.
What interventions are being tested in trial NCT02475278?
The interventions under investigation include: NoV GI.1/GII.4 Bivalent VLP Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02475278?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02475278's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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