Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Phase 2 Interventional Accepts healthy volunteers

Recombinant CMV gB Vaccine in Postpartum Women

ClinicalTrials.gov ID: NCT00125502

Public ClinicalTrials.gov record NCT00125502. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 27, 2026, 8:59 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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
Lead sponsor
Robert Pass, MD
Other
Enrollment
464 participants

Conditions and interventions

Interventions

Biological · Drug

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
Jul 31, 1999
Primary completion
May 31, 2007
Completion
Dec 31, 2009
Last update posted
Sep 19, 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 19, 2011 · Synced Sep 27, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00125502 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →