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

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 3

Conditions: Genital Warts

Treatments: Biological: 9vHPV vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05314023

V503-053 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,590 estimated patients

Sex: Male

Ages: 9 to 19 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,590 participants in 3 patient groups

9 to 19 Years Old: Day 1, Months 2 and 6

Experimental group

Description:

Chinese males 9 to 19 years old will receive a 0.5 mL intramuscular (IM) injection of 9-valent HPV (9vHPV) vaccine on Day 1, Month 2 and Month 6

Treatment:

Biological: 9vHPV vaccine

9 to 14 Years Old: Day 1, and Month 6

Experimental group

Description:

Chinese males 9 to 14 years old will receive a 0.5 mL IM injection of 9vHPV vaccine on Day 1 and Month 6

Treatment:

Biological: 9vHPV vaccine

9 to 14 Years Old: Day 1 and Month 12

Experimental group

Description:

Chinese males 9 to 14 years old will receive a 0.5 mL IM injection of 9vHPV vaccine on Day 1 and Month 12

Treatment:

Biological: 9vHPV vaccine