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NCT02142504 · ClinicalTrials.gov registry record · Phase 2
Safety and Immunogenicity of Norovirus Bivalent Virus-Like Particle Vaccine in Healthy Adults
A Phase 2 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 454
- Enrollment target
NCT02142504: Completed Phase 2 study, sponsored by Takeda.
NCT02142504 is a Phase 2 study that has completed, run by Takeda. The registered enrollment target is 454 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (241% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02142504, a Phase 2 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 454 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety of the norovirus bivalent virus-like particle (VLP) vaccine for further development by assessing the rates of serious adverse events (SAEs), unsolicited adverse events (AEs), solicited local and solicited systemic AEs, Adverse Events of Special Interest (AESIs) and AEs leading to participant's withdrawal from the trial.
Primary Outcome
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after the primary injection.
Interventions
- DRUG Placebo (Saline)
- BIOLOGICAL Norovirus Bivalent VLP Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 454 participants |
| Start Date | 2014-05-15 |
| Est. Completion | 2016-01-06 |
| Phase | Phase 2 |
What the finished NCT02142504 record still lists
NCT02142504 is an interventional study that assigns participants to a tested intervention. The registered 454 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (241% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo (Saline) is the first listed.
NCT02142504 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02142504 about?
NCT02142504 is a clinical study titled "Safety and Immunogenicity of Norovirus Bivalent Virus-Like Particle Vaccine in Healthy Adults". The purpose of this study is to evaluate the safety of the norovirus bivalent virus-like particle (VLP) vaccine for further development by assessing the rates of serious adverse events (SAEs), unsolicited adverse events (AEs), solicited local and solicited systemic AEs, Adverse Events of Special Int...
What is the current status of trial NCT02142504?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 454 participants. The study started on 2014-05-15. Estimated completion is 2016-01-06.
What interventions are being tested in trial NCT02142504?
The interventions under investigation include: Placebo (Saline) (DRUG), Norovirus Bivalent VLP Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02142504?
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 NCT02142504's enrollment target sits among peer trials
454 87th of 2000 higher than 1,914 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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