NCT00645346View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

February 29, 2008

Primary Completion Date

May 31, 2009

Study Completion Date

July 31, 2009

Conditions
Invasive Group B Streptococcus (GBS) Disease
Interventions
BIOLOGICAL

GBS glycoconjugate vaccine

Study subjects will receive either GBS conjugate vaccine or placebo. Total study size is 65. Study subjects will be followed for a total of 12 months after their last vaccination.

BIOLOGICAL

Placebo

Subjects will receive one dose of placebo

Trial Locations (1)

6853

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

Sponsors

Lead Sponsor

Novartis Vaccines
All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY

NCT00645346 - 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 | Biotech Hunter | Biotech Hunter