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

Inclusion criteria

• ✓. Healthy adult female volunteers (as determined by medical history, physical examination, laboratory test values, vital signs and electrocardiograms \[ECGs\] at screening) aged 18 - 40 years.
• ✓. Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
• ✓. Volunteers weight ≥ 50kg and ≤100kg at screening.
• ✓. Able to voluntarily provide written informed consent to participate in the study.
• ✓. Must understand the purposes and risks of the study and agree to follow the restrictions and schedule of procedures as defined in the protocol.
• ✓. Volunteers must be pre-menopausal. Volunteers who have had a hysterectomy will have pre-menopausal status confirmed by a FSH and oestradiol test.
• ✓. Females of childbearing potential must have a negative pregnancy test at screening (β HCG) and prior to each dose and must be willing to use an adequate and highly effective method of contraception until at least Day 85 of the study. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, IUDs (Intrauterine Device), condoms, occlusive caps (cervical/vault caps) with spermicidal foam/gel/ film/cream/suppository. True sexual abstinence is acceptable when this is in line with the preferred and usual lifestyle of the volunteer (periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods, declaration of abstinence for the duration of the trial, and withdrawal are not acceptable methods of contraception)
• ✓. In Part A: Volunteers must be non-smokers for at least 3 months prior to first studyvaccine administration. In Part B: Volunteers may be light smokers i.e. up to a maximum of 5 cigarettes per day or nicotine equivalent.

Exclusion criteria