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NCT02103426 · ClinicalTrials.gov registry record · Phase 1
An Evaluation of a Cytomegalovirus (CMV) Vaccine (ASP0113) in CMV-Seropositive and CMV-Seronegative Healthy Subjects and CMV-Seronegative Dialysis Patients
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT02103426: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT02103426 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. 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
NCT02103426, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of the study is to determine whether ASP0113 (a CMV deoxyribonucleic acid \[DNA\] vaccine) can be detected in plasma after intramuscular (IM) injections, and to determine whether CMV-seropositive healthy volunteers, CMV-seronegative healthy volunteers, CMV-seronegative dialysis patients mount an immune response to the CMV proteins produced by the vaccine after repeated ASP0113 IM injection.
Primary Outcome
Area under the curve (AUC)
Interventions
- DRUG Placebo
- DRUG ASP0113
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2013-12-30 |
| Est. Completion | 2016-05-10 |
| Phase | Phase 1 |
What the finished NCT02103426 record still lists
NCT02103426 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.
NCT02103426 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02103426 about?
NCT02103426 is a clinical study titled "An Evaluation of a Cytomegalovirus (CMV) Vaccine (ASP0113) in CMV-Seropositive and CMV-Seronegative Healthy Subjects and CMV-Seronegative Dialysis Patients". The purpose of the study is to determine whether ASP0113 (a CMV deoxyribonucleic acid \[DNA\] vaccine) can be detected in plasma after intramuscular (IM) injections, and to determine whether CMV-seropositive healthy volunteers, CMV-seronegative healthy volunteers, CMV-seronegative dialysis patients ...
What is the current status of trial NCT02103426?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2013-12-30. Estimated completion is 2016-05-10.
What interventions are being tested in trial NCT02103426?
The interventions under investigation include: Placebo (DRUG), ASP0113 (DRUG).
Who is sponsoring clinical trial NCT02103426?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02103426'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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