drugset / Trial / 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
RandomizedParallel-groupSingle-blindPrevention
Summary
The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect humans from infection.
Timeline
- Start
- 2008-02
- Primary completion
- 2009-05
- Completion
- 2009-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GBS glycoconjugate vaccine | Vaccine | 5 ug | — |
| Subject | GBS glycoconjugate vaccine | Vaccine | 10 ug | — |
| Subject | GBS glycoconjugate vaccine | Vaccine | 20 ug | — |