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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: Completed Phase 2 study, sponsored by Astellas Pharma.

NCT00285259 is a Phase 2 study that has completed, run by Astellas Pharma. The registered enrollment target is 112 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 112 participants
Start Date 2006-01-31
Est. Completion 2010-11-30
Phase Phase 2
Astellas Pharma

165 total trials

What the finished NCT00285259 record still lists

NCT00285259 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower).

The record links to 0 conditions, and to 2 interventions - of which VCL-CB01 is the first listed.

NCT00285259 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00285259's enrollment target sits among peer trials

112 631st of 2000 higher than 1,369 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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Source: ClinicalTrials.gov NCT00285259, the US trial registry maintained by the National Library of Medicine. NCT00285259 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.