Status:
ACTIVE_NOT_RECRUITING
Immunogenicity and Safety of V503 in Chinese Males 9 Through 19 Years Old (V503-053)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Genital Warts
Eligibility:
MALE
9-19 years
Phase:
PHASE3
Brief Summary
This study is designed to demonstrate non-inferior immunogenicity of 3 doses of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) in Chinese males 9 through 19 years of age, and 2 d...
Eligibility Criteria
Inclusion
- Is a healthy Chinese male.
- Has not had sexual debut at the time of enrollment, and does not plan on becoming sexually active during the vaccination period (Day 1 through one month post last dose).
Exclusion
- Has a history of known prior vaccination with an HPV vaccine.
- 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 6 months or plans to receive any before one month post last dose.
- 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.
Key Trial Info
Start Date :
May 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 19 2029
Estimated Enrollment :
1590 Patients enrolled
Trial Details
Trial ID
NCT05314023
Start Date
May 7 2022
End Date
February 19 2029
Last Update
January 19 2023
Active Locations (5)
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1
Liucheng County Centers for Disease Control and Prevention ( Site 0005)
Liuchow, Guangxi, China, 545200
2
Center for Disease Control and Prevention of Rong An ( Site 0006)
Liuchow, Guangxi, China, 545400
3
Loudi Public Health Hospital (Loudi Occupational Disease Prevention And Treatment Hospital) ( Site 0
Louxing District, Hunan, China, 417000
4
Yuechi Disease Prevention and Control Center ( Site 0002)
Guang’an, Sichuan, China, 638399