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

Phase 3Active Not RecruitingNCT05450705

Merck Sharp & Dohme LLC1,500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,500

Conditions

Papillomavirus Infections

Interventions

9vHPV vaccineBIOLOGICAL

A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection.

Eligibility

Sex: FEMALEMin age: 9 YearsMax age: 26 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Jiangshan Center for Disease Control and Prevention ( Site 0001)

Quzhou, Zhejiang, China

Yuhuan Center for Disease Control and Prevention ( Site 0002)

Taizhou, Zhejiang, China

Outcomes

Primary Outcomes

Stage I: Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) to 9 vaccine types of 9vHPV vaccine

cLIA GMT to each of 9 vaccine types of 9vHPV vaccine. The GMT for each HPV type will be reported in mMU/mL.

Time frame: One month after last dose (Up to Month 13)

Stage II: cLIA GMTs to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age

cLIA GMT to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The GMT for each HPV type will be reported in mMU/mL.

Time frame: Up to Month 84

Stage II: cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age

cLIA seropositivity to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The percentage of participants who are seropositive for each HPV type will be summarized.

Time frame: Up to Month 84

Secondary Outcomes

Stage I: cLIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine

cLIA seroconversion to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized.

Time frame: One month after last dose (Up to Month 13)

Stage I: Immunoglobulin G Luminex immunoassay (IgG LIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose

IgG LIA GMT to each of 9 vaccine types of 9vHPV vaccine at one month post last dose. The GMT for each HPV type will be reported in mMU/mL.

Time frame: One month after last dose (Up to Month 13)

Stage I: IgG LIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine

IgG LIA seroconversion to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized.

Data from ClinicalTrials.gov

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