NCT01193920 - Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age | Biotech Hunter

Enrollment

380

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2012

Conditions

Streptococcal Infections

Interventions

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.

Trial Locations (1)

Chris Hani Baragwanath Hospital, Chris Hani Rd, Soweto