Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants
Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants
This Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the
 safety, tolerability and immunogenicity of the investigational multivalent group B
 streptococcus vaccine administered at one dose level (various formulations) in healthy
 nonpregnant women (various formulations at one dose level), and then in healthy pregnant
 women (various formulations at three dose levels), and finally in healthy pregnant women at a
 selected dose level/formulation.
Inclusion Criteria Stage 1 Nonpregnant Women:

 -  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 1 Booster Vaccination:

 -  Subject must have received investigational product at Visit 1.

 -  Healthy nonpregnant female determined by medical history, physical examination, and
 clinical judgment of the investigator to be eligible for booster vaccination and
 received investigational product at Visit 1.

 -  Negative urine pregnancy test at Visit 6 (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 <=40 years of age who are >=27 0/7 (Stage 2) or >=24 0/7
 (Stage 3) to <=35 6/7 weeks' 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.

 Exclusion Criteria Stage 1 Nonpregnant Women:

 -  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 GBS vaccine (other than GBS6
 received as a primary vaccination at Visit 1), 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.