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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: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (208% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00133497 record still lists
NCT00133497 is an interventional study that assigns participants to a tested intervention. The registered 409 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (208% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00133497 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00133497's enrollment target sits among peer trials
409 93rd of 2000 higher than 1,908 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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