drugset / Trial / NCT00657683
A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Monovalent 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
- 2007-12
- Primary completion
- 2009-04
- Completion
- 2009-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Monovalent GBS-CRM glycoconjugate vaccine | Vaccine | — | — |