Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00645346 | A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18- 40 Years of Age | PHASE1 | COMPLETED | 130 | — | — | Feb 1, 2008 | Jul 1, 2009 | Dec 8, 2011 | 1 | Switzerland |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Subjects will receive either 5, 10 or 20 mcg of the vaccine |
| 2 | PLACEBO_COMPARATOR | Subjects will receive placebo control |
| Name | Type | Description |
|---|---|---|
| GBS glycoconjugate vaccine | BIOLOGICAL | Study subjects will receive either GBS conjugate vaccine or placebo. Total study size is 65. Study subjects will be followed for a total of 12 months after their last vaccination. |
| Placebo | BIOLOGICAL | Subjects will receive one dose of placebo |
Inclusion Criteria: * healthy females 18 through 40 years of age; * have provided written informed consent after the nature of the study has been explained; * are available for all visits scheduled for the study (i.e. are not planning to leave the area before the end of the study period); * are in ...