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

A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Invasive Group B Streptococcus (GBS) Disease

Interventions

Type	Name	Description
BIOLOGICAL	Monovalent GBS-CRM glycoconjugate vaccine	1 dose of GBS conjugate vaccine
BIOLOGICAL	Placebo	1 dose of placebo

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2008-04-14
• Last updated: 2011-12-08

Locations

1 site across 1 country: Switzerland