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

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.

Inclusion Criteria:

• Group 1 (Non Pregnant Women): Healthy females 18-40 years of age inclusive.
• Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation)

Exclusion Criteria:

• Group 1 (Non Pregnant Women): Pregnant or nursing; History of severe allergy to previous vaccines; Known HIV positive
• Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive