5
项与 四价人乳头瘤病毒疫苗(汉逊酵母)(成都生物制品研究所) 相关的临床试验A Randomized, Open-label, Non-inferiority Designed Phase IIIb Clinical Trial to Evaluate the Immunogenicity and Safety of Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) Between 2 Doses in Adolescent Females Aged 9-14 Years/3 Doses in Adolescent Females Aged 9-17 Years and Age/Immunization Schedule Bridging in Females Aged 18-26 Year
This vaccine was jointly developed by Chengdu Institute of Biological Products Co., Ltd. and National Vaccine and Serum Institute, China, is co-sponsoring this clinical trial.
This trial plans to enroll 1,800 female subjects aged 9-26 years, 600 in each of the 18-26 years old 3-dose group, 9-17 years old 3-dose group and 9-14 years old 2-dose group.
All subjects in the 9-14 years old 2-dose group will be injected with 2 doses of the experimental vaccine in the deltoid muscle of the upper arm according to the 0-6 month immunization schedule. Subjects in the non-immune persistence subgroup will need to complete 6 on-site visits (V1-V3, V7-V9) and subjects in the immune persistence subgroup will need to complete 12 on-site visits (V1-V3, V7-V15); All subjects in the 9-17 years old 3-dose group and the 18-26 years old 3-dose group will be injected with 3 doses of the experimental vaccine in the deltoid muscle of the upper arm according to the 0, 2, and 6 month immunization schedule. Subjects in the non-immune persistence subgroup will need to complete 9 on-site visits (V1-V9) and subjects in the immune persistence subgroup will need to complete 15 on-site visits (V1-V15).
四价HPV疫苗在18-45岁中国女性中的保护效力、安全性和免疫原性的多中心、随机、双盲、安慰剂对照的III期临床试验
评价四价重组人乳头瘤病毒疫苗(6,11,16,18型)(汉逊酵母)在18-45岁中国女性中的保护效力、安全性和免疫原性
随机、双盲、安慰剂对照评价四价重组HPV疫苗在9-45岁女性人群中免疫原性和安全性的Ⅱ期临床试验
与安慰剂比较评价9-45岁女性人群接种3剂四价重组人乳头瘤病毒疫苗(6,11,16,18 )(汉逊酵母)的免疫原性和安全性
100 项与 四价人乳头瘤病毒疫苗(汉逊酵母)(成都生物制品研究所) 相关的临床结果
100 项与 四价人乳头瘤病毒疫苗(汉逊酵母)(成都生物制品研究所) 相关的转化医学
100 项与 四价人乳头瘤病毒疫苗(汉逊酵母)(成都生物制品研究所) 相关的专利(医药)
1
项与 四价人乳头瘤病毒疫苗(汉逊酵母)(成都生物制品研究所) 相关的新闻(医药)点击蓝字 关注我们
近日,由国药集团中国生物所属成都生物制品研究所和中国生物研究院(新型疫苗国家工程研究中心)联合自主研发的国内首个四价人乳头瘤病毒疫苗(汉逊酵母)(爱薇佳)正式获国家药品监督管理局批准上市。
该疫苗采用与国际主流一致的酵母表达系统制备,在国产二价疫苗预防高危HPV16、18型持续感染引发宫颈癌的基础上,新增了对HPV6、11型持续感染引发生殖器疣的防护,填补了国产二价疫苗对生殖器疣相关低危HPV感染的防护空白。该疫苗Ⅲ期临床试验数据显示,其对预防宫颈CIN2及以上癌前病变的保护效力达100%,有望为适龄人群提供一个高效的防护选择。该疫苗为国药集团旗下首款HPV疫苗,同一技术平台基础上迭代研发的11价HPV疫苗已进入Ⅲ期临床病例收集阶段。
推荐阅读
● 刚刚,首款国产九价HPV疫苗获批上市!
声明:本文由“肿瘤界”整理与汇编,欢迎分享转载,如需使用本文内容,请务必注明出处。
来源:中国生物、成都生物制品研究所
编辑:lagertha
审核:南星
100 项与 四价人乳头瘤病毒疫苗(汉逊酵母)(成都生物制品研究所) 相关的药物交易