Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)
NCT ID: NCT05285826
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
8100 participants
INTERVENTIONAL
2022-02-18
2029-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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V503
Participants will receive a single 0.5 mL intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6.
9vHPV Vaccine
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) L1 virus-like particle vaccine administered as a 0.5-mL IM injection
Placebo
Participants will receive a single 0.5 mL IM injection of placebo at Day 1, Month 2, and Month 6.
Placebo
Sterile saline solution administered as a 0.5 mL IM injection
Interventions
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9vHPV Vaccine
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) L1 virus-like particle vaccine administered as a 0.5-mL IM injection
Placebo
Sterile saline solution administered as a 0.5 mL IM injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has no more than 5 lifetime sexual partners.
Exclusion Criteria
* Has a history of HPV-related external genital lesions, HPV-related intra-anal lesions, or HPV-related head and neck cancer.
* Has a history of severe allergic reaction that required medical intervention.
* Has received immune globulin or blood-derived products in the past 3 months or plans to receive any before Month 7 of the study.
* Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
* Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.
* Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.
20 Years
45 Years
MALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Beijing Youan Hospital ( Site 0001)
Beijing, Beijing Municipality, China
The Second Affiliated Hospital Chongqing Medical University ( Site 0052)
Chongqing, Chongqing Municipality, China
Chongqing Public Health Medical Center ( Site 0003)
Chongqing, Chongqing Municipality, 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 Municipality, China
Tianjin People' s Hospital ( Site 0038)
Tianjin, Tianjin Municipality, 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
First Affiliated Hospital of Kunming Medical University ( Site 0051)
Kunming, Yunnan, China
Yunnan Provincial Infectious Disease Hospital ( Site 0042)
Kunming, Yunnan, China
Zhejiang University School of Medicine - Affiliated Wenzhou Traditional Chinese Medicine Hospital (W
Wenzhou, Zhejiang, China
Countries
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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V503-052
Identifier Type: -
Identifier Source: org_study_id