V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 3

Conditions: Papillomavirus Infections

Treatments: Biological: 9vHPV vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05450705

V503-071 (Other Identifier)

Details and patient eligibility

About

This study aims to demonstrate that a 2-dose regimen of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) to each of the 9vHPV vaccine types in Chinese girls 9 through 14 years of age compared to a 3-dose regimen in Chinese women 20 through 26 years of age. The primary hypothesis is that a 2-dose regimen has a non-inferiority margin of 0.67 in the GMT ratio (girls vs. women) for each HPV type.

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 9 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

• Is a healthy Chinese female.
• Is not a woman of childbearing potential (WOCBP); or is a WOCBP who has not had sex with males or has had sex with males and used effective contraception during Day 1 through 1 month post last dose.

Exclusion Criteria:

• Has a history of known prior vaccination with an HPV vaccine.
• Has a history of severe allergic reaction that required medical intervention.
• Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.
• Has a history of abnormal Pap test or external genital wart, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, anal intraepithelial neoplasia, vulvar cancer, vaginal cancer, or anal cancer.
• Has a history of a positive test for HPV.
• 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, 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 3 patient groups

9 to 14 Years Old: Day 1 and Month 6

Experimental group

Description:

Chinese females 9 to 14 years old will receive a 0.5 mL intramuscular (IM) injection of 9-valent HPV (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 females 9 to 14 years old will receive a 0.5 mL iIM injection of 9-valent HPV (9vHPV) vaccine on Day 1 and Month 12

Treatment:

Biological: 9vHPV vaccine

20 to 26 Years Old: Day 1, Month 2 and Month 6

Experimental group

Description:

Chinese females 20 to 26 years old will receive a 0.5 mL IM injection of 9-valent HPV (9vHPV) vaccine on Day 1, Month 2 and Month 6

Treatment:

Biological: 9vHPV vaccine