Target- |
MechanismImmunostimulants |
|
|
|
Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date31 Dec 2019 |
一项监测馨可宁上市后安全性相关终点的观察性数据库研究
[Translation] An observational database study to monitor safety-related endpoints of Xinkening after marketing
主要目的:描述馨可宁上市前和上市后观察期间9-45岁女性潜在免疫介导性疾病和妊娠结局发生情况。次要目的:1) 描述馨可宁上市前和上市后观察期间9-45岁女性其他严重疾病,包括原发性卵巢功能衰竭、面瘫、复杂性区域疼痛综合征、体位性直立性心动过速综合征的发生情况;2) 描述馨可宁上市前和上市后观察期间9-45岁女性特殊人群(包括HIV感染者、营养不良青少年、疟疾暴露高风险人群、肺结核)潜在免疫介导性疾病和其他严重疾病的发生情况。探索性目的:1) 比较未接种和接种馨可宁的9-45岁女性发生潜在免疫介导性疾病和妊娠结局的差异。
[Translation] Primary objective: To describe the occurrence of potential immune-mediated diseases and pregnancy outcomes in women aged 9-45 years during the pre-marketing and post-marketing observation period of Xinkening. Secondary objectives: 1) To describe the occurrence of other serious diseases in women aged 9-45 years, including primary ovarian failure, facial palsy, complex regional pain syndrome, and postural orthostatic tachycardia syndrome, during the pre-marketing and post-marketing observation period of Xinkening; 2) To describe the occurrence of potential immune-mediated diseases and other serious diseases in special populations of women aged 9-45 years (including HIV-infected people, malnourished adolescents, people at high risk of malaria exposure, and tuberculosis) during the pre-marketing and post-marketing observation period of Xinkening. Exploratory objectives: 1) To compare the differences in the occurrence of potential immune-mediated diseases and pregnancy outcomes in women aged 9-45 years who were not vaccinated and vaccinated with Xinkening.
双价人乳头瘤病毒疫苗(大肠杆菌)在18-45岁健康女性人群中的长期保护性和免疫持久性研究
[Translation] Long-term protection and immune persistence of bivalent human papillomavirus vaccine (Escherichia coli) in healthy women aged 18-45 years
评价双价人乳头瘤病毒疫苗(大肠杆菌)在18-45岁女性人群中的长期保护性和免疫持久性。
[Translation] To evaluate the long-term protection and immune persistence of a bivalent human papillomavirus vaccine (Escherichia coli) in women aged 18-45 years.
双价人乳头瘤病毒疫苗(大肠杆菌)在18-45岁健康女性人群中的长期保护性和免疫持久性研究
[Translation] Long-term protection and immune persistence of bivalent human papillomavirus vaccine (Escherichia coli) in healthy women aged 18-45 years
评价双价人乳头瘤病毒疫苗(大肠杆菌)在18-45岁女性人群中的长期保护性和免疫持久性。
[Translation] To evaluate the long-term protection and immune durability of a bivalent human papillomavirus vaccine (Escherichia coli) in females aged 18-45 years.
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