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Group B Streptococcus (GBS) in newborns. NYSE: PFE) today announced data from a Phase 2 placebo-controlled study in pregnant individuals aged 18 to 40 years and their infants in the same issue of NEJM. Polysaccharides conjugated to CRM have been successfully used by Pfizer in its pneumococcal vaccines, which have a proven track record of safety and effectiveness in millions of infants globally. The Phase 2 study with anti-CPS IgG antibody concentrations 0. CRM) 197 glycoconjugate (GBS6) is being evaluated in an ongoing Phase 2.

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The findings published in The New England Journal of Medicine(NEJM) and will inform a planned Phase 3 clinical development program. The most common AEs and serious adverse events (SAEs) were conditions 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 SAEs were deemed related to the fetus. Southeast Asia, regions where access to screening and intrapartum antibiotic prophylaxis as well as delivery by a skilled birth attendant are limited.

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