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

NCT00657683 ↗

Phase 1 Completed 65 enrolled Novartis Vaccines
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

EvaluationDrugModalityDoseRoute
Subject Monovalent GBS-CRM glycoconjugate vaccine Vaccine — —