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

Phase 1

Completed

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

• Registration Number: NCT00657683
• 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: 2007-12
• Study First Submitted: 2008-03-27
• Study First Submitted QC: 2008-04-08
• Study First Posted: 2008-04-14
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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, clinical judgment of the investigator

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	Monovalent GBS-CRM glycoconjugate vaccine	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

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. S.A.; 🇨🇭 Ligornetto, Switzerland