NCT01193920

Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age

A Phase Ib/II Randomized, Observer-Blind, Controlled, Single Centre Study of a Trivalent Group B Streptococcus Vaccine in Healthy Non-Pregnant Women Leading Into a Dose-Ranging Study in Pregnant Women in South Africa

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.

Conditions

• Streptococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Group B Streptococcus Trivalent Vaccine - 20/20/20 μg	Subjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.
OTHER	Saline solution	Subjects received two injection of saline solution.
BIOLOGICAL	Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg	Subjects received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
BIOLOGICAL	Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg	Subjects received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
BIOLOGICAL	Group B Streptococcus Trivalent Vaccine - 5/5/5 μg	Subjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
OTHER	saline solution	Subjects received one injection of saline solution.

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-12-01
• Completion: 2012-12-01
• First posted: 2010-09-02
• Last updated: 2014-08-22
• Results posted: 2014-05-05

Locations

1 site across 1 country: South Africa