For Healthcare Professionals

Immunogenicity and Safety of V503 in Chinese Males 9 Through 19 Years Old (V503-053)

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About the study

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 doses of the 9vHPV vaccine in Chinese males 9 through 14 years of age, compared to the 3 dose regimen in Chinese males 20 through 26 years of age (from Merck Protocol V503-052). The primary hypothesis is that each of the 3-dose regimen in Chinese males aged 9 through 19 years and 2-dose regimens in Chinese males aged 9 through 14 years induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) at one month post last dose compared to the 3-dose regimen in Chinese adult males aged 20 through 26 years. A noninferiority margin of 0.67 in the GMT ratio (9 through 19 years of age or 9 through 14 years of age vs 20 through 26 years of age) is used for each HPV type.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Is a healthy Chinese male.
  2. 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 CRITERIA

Exclusion Criteria:


  1. Has a history of known prior vaccination with an HPV vaccine.
  2. Has a history of HPV-related external genital lesions, HPV-related intra-anal lesions, or HPV-related head and neck cancer.
  3. Has a history of severe allergic reaction that required medical intervention.
  4. Has received immune globulin or blood-derived products in the past 6 months or plans to receive any before one month post last dose.
  5. 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.
  6. Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.
  7. Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Genital Warts

Age (in years)

9 - 19

Phase

Phase 3

Participants needed

1590

Est. Completion Date

Feb 19, 2029

Treatment type

Interventional


Sponsor

Merck Sharp & Dohme LLC

ClinicalTrials.gov identifier

NCT05314023

Study number

V503-053

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