At a glance
ClinicalIndex Comparison Record- ✓Participated in and completed the group B Streptococcus (GBS) Screening Protocol
- ✓Non-pregnant women aged 18-40 years
- ✓Currently sexually active (sex with male at least once in last 4 months)
- ✓Current use of effective birth control with intention to continue for at least 30 days
- ✕GBS positive by culture (vaginal and/or rectal) or culture positive for streptococcal strains that cross-react with GBS typing sera
- ✕Pregnant women (urine pregnancy test required prior to vaccination)
- ✕Serious underlying disease including immunodeficiency, active or chronic hepatitis, immunosuppressive conditions requiring systemic steroid therapy, or malignancy treatment in past year
- ✕Receipt of any vaccine, blood product, or experimental medicine within past 30 days (exception: licensed inactivated influenza vaccine)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Randomized, Double-Blinded, Comparative Clinical Trial for a Group B Streptococcus Serotype III-Tetanus Toxoid (GBS III-TT) Vaccine to Prevent Vaginal Acquisition of GBS Type III
In Brief
A Phase 2 clinical trial evaluating GBS III-TT and Tetanus and diptheria toxoids vaccine for Beta Haemolytic Streptococcal Infection. Completed, enrolled 667 participants across 3 sites.
Detailed Summary
The group B streptococcus (GBS) vaccine study is being done to see if a single vaccination with a GBS type III vaccine can stop women from getting GBS type III bacteria in the vagina. Approximately 600 women, ages 18-40, will be enrolled from the clinical sites participating in this study. Participants will be non-pregnant, sexually active (sex with a male at least once in the last 4 months), and GBS negative in the vagina or rectum at the screening visit. Participants will be randomly assigned to receive the experimental GBS type III vaccine or a licensed vaccine containing Tetanus and Diphtheria Toxoids (Td). Participants will be followed at one month, 2 months and every other month thereafter following vaccination (for vaginal and rectal swab collection and a blood draw) for 1½ years or a total of 10 post vaccination visits.
Study Details
Timeline
Interventions
50 mcg GBS Type III capsular polysaccharide conjugated to 32 mcg of tetanus toxoid. A single dose of vaccine administered by intramuscular (IM) injection in the upper arm. All subjects will receive a volume of 0.5 ml.
Td vaccine is a sterile solution of alum-precipitated toxoids in isotonic sodium chloride solution. A single dose of vaccine will be administered by intramuscular (IM) injection in the upper arm. All subjects will receive a volume of 0.5 ml. Each 0.5 ml dose is formulated to contain 5 Lf (flocculation units) of tetanus toxoid and 2 Lf of diphtheria toxoid.