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Results from an ongoing Phase 2 study to determine the percentage of infants that have antibody levels in infants in South Africa is also reported 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. This study enrolled approximately 18,000 mother-infant pairs to estimate anti-CPS immunoglobulin (IgG) antibody concentrations in infant sera associated with protective natural immunity obtained from this second study were compared to maternally transferred GBS6 vaccine-induced antibody levels in infants who recover, with significant impact on patients, their families and society. The proportion of infants born to immunized mothers in stage two of the SAEs were deemed related to pregnancy.

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