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NCT00201448 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Safety and Immune Responses of the Towne Strain of CMV in Seronegative Women
A Phase 2 study, sponsored by Virginia Commonwealth University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
NCT00201448: Clinical Trial Phase 2 study, sponsored by Virginia Commonwealth University.
NCT00201448 is a Phase 2 study that was terminated before completion, run by Virginia Commonwealth University. The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00201448, a Phase 2 study, was terminated before completion, sponsored by Virginia Commonwealth University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of a vaccine given to women ages 18-45 to prevent cytomegalovirus (CMV), which they may catch from their children who attend daycare centers. Cytomegalovirus does not usually cause serious illness in adults and children. However, CMV can be a cause of deafness and mental retardation in a child born from a mother who has the infection during pregnancy. Women in the study will be given either cytomegalovirus or Hepatitis A vaccine. A blood sample will be taken before the vaccination is given. After vaccination, urine, saliva, and blood will be collected every 1-6 months for up to 3 years. Information regarding any reaction to the vaccination will be collected. All family members will be asked to provide urine and saliva to test for CMV every few months for up to 3 years. All children born to women who have been vaccinated will be tested for CMV infection. 180 women who are not infected with CMV will be vaccinated.
Interventions
- BIOLOGICAL Hepatitis A Vaccine
- BIOLOGICAL Towne CMV Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2007-06 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
Why NCT00201448 stopped before completion
NCT00201448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Hepatitis A Vaccine is the first listed.
NCT00201448 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00201448 about?
NCT00201448 is a clinical study titled "Evaluation of the Safety and Immune Responses of the Towne Strain of CMV in Seronegative Women". The purpose of this study is to evaluate the safety and effectiveness of a vaccine given to women ages 18-45 to prevent cytomegalovirus (CMV), which they may catch from their children who attend daycare centers. Cytomegalovirus does not usually cause serious illness in adults and children. However, ...
What is the current status of trial NCT00201448?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2007-06. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00201448?
The interventions under investigation include: Hepatitis A Vaccine (BIOLOGICAL), Towne CMV Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00201448?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00201448's enrollment target sits among peer trials
82 830th of 2000 higher than 1,167 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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