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We strive to set the standard for quality, safety and value in the discovery, development and review of drugs and vaccines that are intended to treat or prevent serious conditions, and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on clinically significant endpoints. Stage 1: Evaluated safety and immunogenicity in 360 healthy pregnant individuals showed the investigational vaccine, GBS6, was generally well-tolerated and generated robust maternal antibody responses that were efficiently transferred to infantsThe safety profile was similar between the vaccine and placebo groups was similar.

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