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NCT01764256 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine
A Phase 1 study, sponsored by PATH.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01764256: Completed Phase 1 study, sponsored by PATH.
NCT01764256 is a Phase 1 study that has completed, run by PATH. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01764256, a Phase 1 study, has completed, sponsored by PATH.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult volunteers to determine if it is safe and if the immune systems of healthy adults respond to this vaccine.
Primary Outcome
Adverse events were collected through 28 days following the final study injection and were graded for severity. Unsolicited adverse events were also assessed for relationship to vaccine. A final follow-up contact was attempted 6 months following the final study injection to inquire about new chronic health conditions, serious health events, and hospitalizations.
Interventions
- OTHER placebo
- BIOLOGICAL P2-VP8 subunit rotavirus vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2012-12 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
What the finished NCT01764256 record still lists
NCT01764256 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01764256 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01764256 about?
NCT01764256 is a clinical study titled "A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine". This study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult volunteers to determine if it is safe and if the immune systems of healthy adults respond to this vaccine.
What is the current status of trial NCT01764256?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2012-12. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01764256?
The interventions under investigation include: placebo (OTHER), P2-VP8 subunit rotavirus vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01764256?
This trial is sponsored by PATH, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01764256's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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