- Healthy nonpregnant females 18 to 40 years of age at enrollment who are determined by
medical history, physical examination, and clinical judgment of the investigator to be
eligible for inclusion in the study.
- Negative urine pregnancy test at Visit 1 (prior to vaccination).
- Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B
virus (HBV) infection at screening.
Inclusion Criteria Stage 2 and 3 Maternal Subjects:
- Healthy females >=18 and
gestation on the day of planned vaccination, with an uncomplicated, singleton
pregnancy, and at no increased risk for complications and no significant fetal
abnormalities observed on ultrasound performed at any time prior to study entry and/or
at the screening visit.
- Documented negative HIV antibody, HBV surface antigen, HCV antibody, and syphilis
tests at screening.
Inclusion Criteria Stage 2 and 3 Infant Subjects:
Evidence of a signed and dated ICD signed by the parent(s). Parent(s) willing and able to
comply with scheduled visits, investigational plan, laboratory tests, and other study
procedures.
- Acute or chronic medical or psychiatric condition including recent (within the past
year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the investigational product or any
diphtheria toxoid-containing or CRM197 containing vaccine.
- History of microbiologically proven invasive disease caused by GBS (S agalactiae).
- Previous vaccination with any licensed or investigational group B streptococcus
vaccine, or planned receipt during the subject's participation in the study (through
the last blood draw).
Exclusion criteria Stage 2 and 3 Maternal Subjects:
- Acute or chronic medical or psychiatric condition including recent (within the past
year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the investigational product or any
diphtheria toxoid-containing or CRM197 containing vaccine.
- History of microbiologically proven invasive disease caused by GBS (S agalactiae).
- Previous vaccination with any licensed or investigational group B streptococcus
vaccine, or planned receipt during the subject's participation in the study (through
the last blood draw).
- Body mass index (BMI) of >=40 kg/m2 at the time of the screening visit.
- A prior history of or current pregnancy complications or abnormalities that will
increase the risk associated with the subject's participation.
- Major illness of the mother or conditions of the fetus that, in the investigator's
judgment, will substantially increase the risk associated with the subject's
participation in, and completion of, the study or could preclude the evaluation of the
subject's response.
Exclusion criteria Stage 2 and 3 Infant Subjects:
Infant who is a direct descendant (eg, child or grandchild) of the study personnel.