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

NCT00645346 Phase 1 COMPLETED

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.

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 1
Status	COMPLETED
Enrolment	130
Start date	2008-02
Completion	2009-07

Conditions

• Invasive Group B Streptococcus (GBS) Disease

Interventions

• GBS glycoconjugate vaccine
• Placebo

Primary outcomes

• To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine — 1 month

Countries

Switzerland