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NCT00285259 · ClinicalTrials.gov registry record · Phase 2
Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
A Phase 2 study, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
NCT00285259 is a Phase 2 study that has completed, run by Astellas Pharma. The registered enrollment target is 112 participants.
The verdict
NCT00285259, a Phase 2 study, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
Study Summary
The purpose of this trial is to evaluate a CMV vaccine given to related donor/recipient pairs (donors prior to peripheral blood stem cell donation and CMV-seropositive recipients just before and after transplantation) and CMV-seropositive recipient-only subjects (related or unrelated) to determine incidence rates of CMV infection, disease, and other complications from immunosuppression and/or transplantation. The outcomes for the groups receiving CMV vaccine will be compared to the outcomes for the group that received the placebo vaccine to see if there is a clinical benefit. For this trial, donors and recipients must have matched HLA genotype (matched at 5/6 or 6/6 HLA loci).
Interventions
- BIOLOGICAL VCL-CB01
- OTHER Phosphate-buffered Saline (PBS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2006-01-31 |
| Est. Completion | 2010-11-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00285259
The ClinicalTrials.gov registry entry for NCT00285259 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma, which has 165 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which VCL-CB01 is the first listed.
NCT00285259 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00285259 about?
NCT00285259 is a clinical study titled "Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)". The purpose of this trial is to evaluate a CMV vaccine given to related donor/recipient pairs (donors prior to peripheral blood stem cell donation and CMV-seropositive recipients just before and after transplantation) and CMV-seropositive recipient-only subjects (related or unrelated) to determine i...
What is the current status of trial NCT00285259?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2006-01-31. Estimated completion is 2010-11-30.
What interventions are being tested in trial NCT00285259?
The interventions under investigation include: VCL-CB01 (BIOLOGICAL), Phosphate-buffered Saline (PBS) (OTHER).
Who is sponsoring clinical trial NCT00285259?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
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