Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria Stage 1 Nonpregnant Women:
Inclusion Criteria Stage 1 Booster Vaccination:
Inclusion Criteria Stage 2 and 3 Maternal Participants:
Inclusion Criteria Stage 2 and 3 Infant Participants:
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:
Exclusion criteria Stage 2 and 3 Maternal Participants:
Exclusion criteria Stage 2 and 3 Infant Participants:
Infant who is a direct descendant (eg, child or grandchild) of the study personnel.
Primary purpose
Allocation
Interventional model
Masking
1,208 participants in 12 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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