Target- |
MechanismImmunostimulants |
|
|
|
|
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date24 Mar 2022 |
一项开放、长期扩展研究评估在311-HPV-1005研究时9-30岁健康女性接种双价人乳头瘤病毒疫苗(毕赤酵母)的免疫持久性
[Translation] An open-label, long-term extension study evaluating the durability of immunity in healthy women aged 9 to 30 years who received a bivalent human papillomavirus vaccine (Pichia pastoris) at the time of Study 311-HPV-1005
主要目的:评估9-30岁健康女性按0、2、6月免疫程序接种双价HPV疫苗后的长期免疫持久性。
次要目的:收集和分析接种疫苗后HPV相关疾病的发生情况,探索双价HPV疫苗的长期保护效果。
[Translation] Primary purpose: To evaluate the long-term immune persistence of healthy women aged 9-30 years after bivalent HPV vaccination according to the 0, 2, and 6 month immunization schedule.
Secondary purpose: To collect and analyze the occurrence of HPV-related diseases after vaccination and explore the long-term protective effect of bivalent HPV vaccine.
一项多中心、开放、长期扩展研究评估在311-HPV-1003研究时18-30岁健康女性接种双价人乳头瘤病毒疫苗(毕赤酵母)的长期保护效力、免疫持久性
[Translation] A multicenter, open-label, long-term extension study to evaluate the long-term protective efficacy and immune persistence of a bivalent human papillomavirus vaccine (Pichia pastoris) in healthy women aged 18-30 years who were vaccinated during the 311-HPV-1003 study
主要目的:评价18-30岁健康女性接种双价人乳头瘤病毒疫苗(毕赤酵母)的长期保护效力
次要目的:评价18-30岁健康女性接种双价人乳头瘤病毒疫苗(毕赤酵母)的免疫持久性
[Translation] Primary objective: To evaluate the long-term protective efficacy of bivalent human papillomavirus vaccine (Pichia pastoris) in healthy women aged 18-30 years. Secondary objective: To evaluate the immune persistence of bivalent human papillomavirus vaccine (Pichia pastoris) in healthy women aged 18-30 years.
一项开放、长期扩展研究评估在311-HPV-1004研究时9-26岁健康女性接种双价人乳头瘤病毒疫苗(毕赤酵母)的免疫持久性
[Translation] An open-label, long-term extension study evaluating the durability of immunity in healthy women aged 9 to 26 years who received a bivalent human papillomavirus vaccine (Pichia pastoris) during study 311-HPV-1004
主要目的:评价在311-HPV-1004研究入组时9-26岁健康女性接种双价HPV疫苗的长期免疫持久性(首剂接种后第84月、108月和132月)。 次要目的:评价采用高通量假病毒检测方法评估311-HPV-1004研究第0、7、12、24和36月中和抗体水平(仅限于本次311-HPV-1004-EXTEND研究入组时的受试者)。
[Translation] Primary objective: To evaluate the long-term immunity persistence of bivalent HPV vaccine in healthy women aged 9-26 years at the time of enrollment in the 311-HPV-1004 study (84 months, 108 months, and 132 months after the first dose). Secondary objective: To evaluate the neutralizing antibody levels at 0, 7, 12, 24, and 36 months in the 311-HPV-1004 study using a high-throughput pseudovirus assay (limited to subjects enrolled in this 311-HPV-1004-EXTEND study).
100 Clinical Results associated with Yuxi Zerun Biotechnology Co., Ltd.
0 Patents (Medical) associated with Yuxi Zerun Biotechnology Co., Ltd.
100 Deals associated with Yuxi Zerun Biotechnology Co., Ltd.
100 Translational Medicine associated with Yuxi Zerun Biotechnology Co., Ltd.