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Vaxchora, Cholera Vaccine Live Oral
申请企业
Emergent Travel Health, Inc.
药品名称
Vaxchora, Cholera Vaccine Live Oral
承诺描述
Deferred pediatric study (PXVX-VC-200-006) under PREA for active immunization against disease caused by V. cholerae serogroup O1 in pediatric patients ages 2 years to less than 18 years traveling to cholera-affected areas. This study will evaluate the safety and immunogenicity of VAXCHORA in this age group.
承诺状态描述
Per FDA letter dated December 23, 2020, this PMR has been fulfilled.