Spots Global Cancer Trial Database for Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)
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Trial Identification
Brief Title: Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy, Immunogenicity, and Safety of V503, a 9-Valent Human Papillomavirus (HPV) Vaccine, in Chinese Males 20 to 45 Years of Age
Study ID: NCT05285826
Conditions
Study Description
Brief Summary: This study will evaluate the efficacy, immunogenicity, and safety of 9-valent human papillomavirus (9vHPV; V503) vaccine in Chinese men 20 to 45 years of age. It will enroll heterosexual men (HM) and men who have sex with men (MSM), will be stratified by age and sexual orientation, and will have two stages. The primary hypothesis of Stage I is: 9vHPV vaccine reduces the combined incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related external genital and intra-anal 12-month persistent infection (PI) compared with placebo in males 20 to 45 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR) negative from Day 1 through one month post-Dose 3 to the relevant HPV type. The primary hypothesis of Stages I and II combined is: 9vHPV vaccine reduces the combined incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), or penile/perianal/perineal cancer compared with placebo in males 20 to 45 years of age who are seronegative at Day 1 and PCR negative from Day 1 through one month post-Dose 3 to the relevant HPV type.
Detailed Description:
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT
Sex: MALE
Healthy Volunteers: Yes
Locations
Beijing Youan Hospital ( Site 0001), Bejing, Beijing, China
The Second Affiliated Hospital Chongqing Medical University ( Site 0052), Chongqing, Chongqing, China
Chongqing Public Health Medical Center ( Site 0003), Chongqing, Chongqing, China
The First Hospital of Lanzhou University ( Site 0034), Lanzhou, Gansu, China
Southern Medical University Nanfang Hospital-Center for Drug Clinical Research ( Site 0031), Guangzhou, Guangdong, China
The University of Hong Kong - Shenzhen Hospital ( Site 0049), Shenzhen, Guangdong, China
Center for Disease Control and Prevention of Rong An ( Site 0046), Liuzhou, Guangxi, China
Liucheng County Centers for Disease Control and Prevention ( Site 0045), Liuzhou, Guangxi, China
Wuhan Union Hospital ( Site 0032), Wuhan, Hubei, China
Hunan Provincial Center for Disease Control and Prevention ( Site 0040), Changsha, Hunan, China
The Third Xiangya Hospital of Central South University ( Site 0033), Changsha, Hunan, China
Loudi Disease Prevention and Control Center Zhiyebing Prevention And Treatment Hospital ( Site 0015), Louxing District, Hunan, China
Xiangtan Disease Prevention and Control Center ( Site 0030), XiangTan, Hunan, China
Xiangxiang Disease Prevention and Control Center ( Site 0016), Xiangxiang, Hunan, China
Qiyang Center for Disease Control and Prevention ( Site 0014), Yongzhou, Hunan, China
The Second Hospital of Nanjing (Tangshan Branch) ( Site 0028), Nanjing, Jiangsu, China
The first affiliated hospital of China medical university ( Site 0041), Shenyang, Liaoning, China
Liaoning University of Traditional Chinese Medicine Affiliated Hospital ( Site 0048), Shenyang, Liaoning, China
Yuanqu Center for Disease Control and Prevention ( Site 0019), Yuncheng, Shanxi, China
Yanhu Center for Disease Control and Prevention of Yuncheng ( Site 0018), Yuncheng, Shanxi, China
Yongji Center for Disease Control and Prevention ( Site 0026), Yuncheng, Shanxi, China
Ruicheng Center for Disease Control and Prevention ( Site 0025), Yuncheng, Shanxi, China
Dazhu Disease Prevention and Control Center ( Site 0010), Dazhou, Sichuan, China
Yuechi Disease Prevention and Control Center ( Site 0009), Guang'an, Sichuan, China
Mianyang Center for Disease Control and Prevention ( Site 0007), Mianyang, Sichuan, China
Santai County Center for Disease Control and Prevention ( Site 0008), Mianyang, Sichuan, China
Neijiang Center for Disease Control and Prevention ( Site 0011), Neijiang, Sichuan, China
Tianjin Second People's Hospital ( Site 0004), Tianjin, Tianjin, China
Tianjin People' s Hospital ( Site 0038), Tianjin, Tianjin, China
Binchuan County Center for Disease Control and Prevention ( Site 0022), Dali, Yunnan, China
Xiangyun County Center for Disease Control and Prevention ( Site 0021), Dali, Yunnan, China
Yunnan Provincial Infectious Disease Hospital ( Site 0042), Kunming City, Yunnan, China
First Affiliated Hospital of Kunming Medical University ( Site 0051), Kunming, Yunnan, China
Zhejiang University School of Medicine - Affiliated Wenzhou Traditional Chinese Medicine Hospital (W, Wenzhou Shi, Zhejiang, China
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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