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NCT00133497 · ClinicalTrials.gov registry record · Phase 2
gB/MF59 Vaccine in Preventing Cytomegalovirus Infection in Healthy Adolescent Females
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 409
- Enrollment target
NCT00133497 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 409 participants.
The verdict
NCT00133497, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 409 participants
- Enrollment target
Study Summary
The purpose of this research study is to test the safety of and the body's response to an experimental cytomegalovirus (CMV) vaccine (called gB/MF59 vaccine). Participants will include approximately 400 healthy females, ages 12-17, recruited from adolescent clinics at Cincinnati Children's Hospital Medical Center, Vanderbilt University Medical Center, Baylor College of Medicine, University of Texas School of Public Health, Houston, and the University of Texas Medical Branch at Galveston. Participants will receive 3 doses of vaccine or placebo (saltwater) on a 0, 1, and 6 month schedule. Study procedures will include blood and urine samples. Participants will complete a diary recording temperatures and any side effects experienced. Subjects will be involved in study related procedures for up to 31 months.
Interventions
- DRUG Placebo
- BIOLOGICAL MF-59
- BIOLOGICAL CMV gB vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 409 participants |
| Start Date | 2006-06 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00133497
The ClinicalTrials.gov registry entry for NCT00133497 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 409 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00133497 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00133497 about?
NCT00133497 is a clinical study titled "gB/MF59 Vaccine in Preventing Cytomegalovirus Infection in Healthy Adolescent Females". The purpose of this research study is to test the safety of and the body's response to an experimental cytomegalovirus (CMV) vaccine (called gB/MF59 vaccine). Participants will include approximately 400 healthy females, ages 12-17, recruited from adolescent clinics at Cincinnati Children's Hospital ...
What is the current status of trial NCT00133497?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 409 participants. The study started on 2006-06. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00133497?
The interventions under investigation include: Placebo (DRUG), MF-59 (BIOLOGICAL), CMV gB vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00133497?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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