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

NCT00657683 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	65
Start date	2007-12
Completion	2009-05

Conditions

• Invasive Group B Streptococcus (GBS) Disease

Interventions

• Monovalent GBS-CRM glycoconjugate vaccine
• Placebo

Primary outcomes

• To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine. Safety will be assessed by measuring the incidence of local and systemic reactogenicity, adverse events and serious adverse events. — 1 month

Countries

Switzerland