Spots Global Cancer Trial Database for A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SCT1000 in Healthy Women Aged 18-45 Years
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Trial Identification
Brief Title: A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SCT1000 in Healthy Women Aged 18-45 Years
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Efficacy, Safety, and Immunogenicity of a 14- Valent Recombinant Human Papillomavirus Vaccine (SCT1000) in Healthy Women Aged 18-45 Years
Study ID: NCT06041061
Study Description
Brief Summary: A total of 18000 healthy women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 36-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.
Detailed Description: Introduction: SCT1000 is a recombinant 14-valent human papillomavirus vaccine (insect cell) that covers all 12 WHO-recognized high-risk oncogenic HPV subtypes Indications are for the prevention of cervical, vulvar, vaginal, and anal cancers, and genital warts caused by HPV6, HPV11 and HPV11 in females 9-45 years of age, as well as intraepithelial neoplasia and AIS. Intraepithelial neoplasia and AIS and genital warts due to HPV6 and HPV11. Aim:To evaluate the protective efficacy of 3 doses of HPV vaccine (SCT1000) for the prevention of HPV type 6,11,16,18,31,33,35,39,45,51,52,56,58,59-associated lesions in healthy females aged 18-45 years compared with placebo. Design: A Multicenter, Randomized, Double-blind, Placebo-controlled phase III Clinical trial Subject Information: a total of 18000 healthy women aged 18-45 years selected by inclusion and exclusion criteria. Cluster situation: a ratio of 1:1 between the experimental group and the placebo group. End point index: relative index with efficacy, safety, and immunogenicity of SCT1000
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China
Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China
Shanxi Center for Disease Control and Prevention, Taiyuan, Shanxi, China
Sichuan Center for Disease Control and Prevention, Chengdu, Sichuan, China
Yunan Center for Disease Control and Prevention, Kunming, Yunan, China
Contact Details
Name: Yi Mo
Affiliation: Guangxi Center for Disease Control and Prevention
Role: PRINCIPAL_INVESTIGATOR
Name: Yan Zheng
Affiliation: Yunnan Center for Disease Control and Prevention
Role: PRINCIPAL_INVESTIGATOR
Name: Guohua Li
Affiliation: Shanxi Center for Disease Control and Prevention
Role: PRINCIPAL_INVESTIGATOR
Name: Ting Huang
Affiliation: Sichuan Center for Disease Control and Prevention
Role: PRINCIPAL_INVESTIGATOR
Name: Zhiqaing Xie
Affiliation: Henan Center for Disease Control and Prevention
Role: PRINCIPAL_INVESTIGATOR
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