Target- |
MechanismImmunostimulants |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date24 Mar 2022 |
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).
A Phase III, Randomized, Double-blind Study to Assess the Consistency of the Immunogenicity of Three Consecutive Production Lots of Bivalent HPV Vaccine in Healthy Female Subjects Aged 9 - 30 Years and to Demonstrate Non-inferiority of the Candidate HPV Vaccine Manufactured at Commercial Scale Compared With a Pilot Scale
The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of bivalent HPV (Type 16,18) vaccine (Pichia pastoris) in healthy female subjects aged 9 - 30 years, and demonstrate the non-inferiority of the candidate HPV vaccine manufactured at commercial scale compared with a pilot scale.
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