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项与 四价重组人乳头瘤病毒疫苗(6,11,16,18型)(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 四价重组人乳头瘤病毒疫苗(6,11,16,18型)(汉逊酵母)(成都生物制品研究所) 相关的临床结果
100 项与 四价重组人乳头瘤病毒疫苗(6,11,16,18型)(汉逊酵母)(成都生物制品研究所) 相关的转化医学
100 项与 四价重组人乳头瘤病毒疫苗(6,11,16,18型)(汉逊酵母)(成都生物制品研究所) 相关的专利(医药)
100 项与 四价重组人乳头瘤病毒疫苗(6,11,16,18型)(汉逊酵母)(成都生物制品研究所) 相关的药物交易