Status:
ACTIVE_NOT_RECRUITING
Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Papillomavirus Infections
Eligibility:
MALE
20-45 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Is a Chinese male.
- Has no more than 5 lifetime sexual partners.
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 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.
Key Trial Info
Start Date :
February 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 25 2029
Estimated Enrollment :
8100 Patients enrolled
Trial Details
Trial ID
NCT05285826
Start Date
February 18 2022
End Date
May 25 2029
Last Update
December 16 2024
Active Locations (34)
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1
Beijing Youan Hospital ( Site 0001)
Beijing, Beijing Municipality, China, 100069
2
The Second Affiliated Hospital Chongqing Medical University ( Site 0052)
Chongqing, Chongqing Municipality, China, 400010
3
Chongqing Public Health Medical Center ( Site 0003)
Chongqing, Chongqing Municipality, China, 400036
4
The First Hospital of Lanzhou University ( Site 0034)
Lanzhou, Gansu, China, 730000