NCT01150123

Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women

A Phase Ib Randomized, Observer-Blind, Controlled, Single Center, Dose-Ranging Study of a Group B Streptococcus Vaccine in Healthy Women 18-40 Years of Age

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 678 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.

Conditions

• Group B Streptococcus

Interventions

Type	Name	Description
BIOLOGICAL	Group B streptococcus (GBS) vaccine- low dose
BIOLOGICAL	Group B streptococcus (GBS) vaccine- High dose
BIOLOGICAL	Placebo- Saline

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-11-01
• Completion: 2012-10-01
• First posted: 2010-06-24
• Last updated: 2017-05-15
• Results posted: 2017-05-15

Locations

1 site across 1 country: Belgium