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

PHASE1CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

April 30, 2009

Study Completion Date

May 31, 2009

Conditions
Invasive Group B Streptococcus (GBS) Disease
Interventions
BIOLOGICAL

Monovalent GBS-CRM glycoconjugate vaccine

1 dose of GBS conjugate vaccine

BIOLOGICAL

Placebo

1 dose of placebo

Trial Locations (1)

6853

Institute for Pharmacokinetic and Analytical Studies, I.P.A.S. S.A., Ligornetto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY