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

Phase 1

Completed

• Conditions: Invasive Group B Streptococcus (GBS) Disease
• Interventions: Biological: GBS glycoconjugate vaccine; Biological: Placebo

• Registration Number: NCT00645346
• Lead Sponsor: Novartis Vaccines

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-21
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-27
• Primary Completion: 2009-05
• Study Completion: 2009-07
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• healthy females 18 through 40 years of age;
• have provided written informed consent after the nature of the study has been explained;
• are available for all visits scheduled for the study (i.e. are not planning to leave the area before the end of the study period);
• are in good health as determined by: medical history ,physical assessment

Exclusion Criteria

• unwilling or unable to give written informed consent to participate in the study;
• pregnant (serum pregnancy test)
• unwilling to use acceptable birth control from screening and until at least 3 months after the final immunization
• nursing (breastfeeding) mothers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	GBS glycoconjugate vaccine	Subjects will receive either 5, 10 or 20 mcg of the vaccine
2	Placebo	Subjects will receive placebo control

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine	1 month

Secondary Outcome Measures

Name	Time	Method
To study the magnitude and durability of GBS-specific antibody responses over 12 months.	12 months

Trial Locations

Locations (1)

Institute for Pharmacokinetic and Analytical Studies I.P.A.S.; 🇨🇭 Ligornetto, Switzerland