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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 is a Phase 2 study that was terminated before completion, run by Virginia Commonwealth University. The registered enrollment target is 82 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00201448
The ClinicalTrials.gov registry entry for NCT00201448 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Hepatitis A Vaccine is the first listed.
NCT00201448 reports 0 study locations.
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.
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