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AlPO4 adjuvantor placebo, given from late second trimester. Breakthrough Therapy Designation is designed to expedite 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. The findings published in The New England Journal of Medicine(NEJM) and will inform a planned Phase 3 clinical development program.

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