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

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

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.

Study Overview

• Status: Completed
• Conditions: Invasive Group B Streptococcus (GBS) Disease
• Intervention / Treatment: Biological: Monovalent GBS-CRM glycoconjugate vaccine; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Ligornetto, Switzerland, 6853
    • Institute for Pharmacokinetic and Analytical Studies, I.P.A.S. S.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Biological: Monovalent GBS-CRM glycoconjugate vaccine; 1 dose of GBS conjugate vaccine
Placebo Comparator: 2	Biological: Placebo; 1 dose of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
To study the magnitude and durability of GBS-specific antibody responses over 12 months.	12 months

Collaborators and Investigators

• Sponsor: Novartis Vaccines

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: March 27, 2008
• First Submitted That Met QC Criteria: April 8, 2008
• First Posted (Estimate): April 14, 2008

Study Record Updates

• Last Update Posted (Estimate): December 8, 2011
• Last Update Submitted That Met QC Criteria: December 7, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: GBS; GBS prevention
• Other Study ID Numbers: V98P1