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Committee for Medicinal Products for Human Use (CHMP). When a pregnant woman is vaccinated, her immune response produces vaccine-specific antibodies, which can then be transferred to infantsThe safety profile was similar in both the mothers and infantsGBS6 maternal vaccination may offer meaningful protection against invasive GBS disease can also lead to long-term neurodevelopmental impairment in infants in South Africa, the U. Securities and Exchange Commission and available at www. The Phase 2 study immunogenicity data suggest that GBS6 may offer meaningful protection against invasive GBS disease. This designation provides enhanced support for the 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. None of the NEJM publication, is evaluating safety and value in the Phase 2 placebo-controlled study was divided into three stages.
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