Recombinant CMV gB Vaccine in Postpartum Women
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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT00125502. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.
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Official title
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial of Recombinant CMV gB Vaccine in Postpartum Women
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine if a new cytomegalovirus (CMV) vaccine (CMV gB/MF59) can safely prevent mothers from catching CMV infection between pregnancies. This study includes 464 women, ages 14-40 years, who delivered a newborn infant within 12 months prior to the study. Participants must live within the Birmingham metropolitan area or the Tuscaloosa county area and they cannot have had CMV infection previously. CMV vaccine or placebo (substance containing no medication) will be given at 3 study visits. Participants fill out diary cards for 7 days after each vaccination. Blood samples will be collected. Urine samples will be collected several times and pregnancy tests will be performed. Participants who tested positive for CMV will have urine, vaginal swab, and saliva specimens collected. Each participant will be followed for 3 years after the third dose of vaccine. Infants born to participants in the study will be checked for CMV infection.
Study identification
- NCT ID
- NCT00125502
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 464 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 14 Years to 40 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 1999 (Type not available)
- Primary completion
- Jun 2007 (Actual)
- Completion
- Jan 2010 (Actual)
- Last update posted
- Sep 20, 2011
1999 – 2010
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-3293 | — |
| University of Alabama at Tuscaloosa | Tuscaloosa | Alabama | 35487 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00125502, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 20, 2011 · Synced Nov 15, 2026
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