Clinical trial NCT05450705: V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)
Official title: A Phase 3 Open-Label Immunogenicity and Safety Study of 2-Dose Regimens of a 9vHPV Vaccine (V503) in Chinese Girls 9 Through 14 Years of Age With a Comparison to 3-Dose Regimen of V503 in Chinese Women 20 Through 26 Years of Age
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Papillomavirus Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-07-11
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Stage I: Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) to 9 vaccine types of 9vHPV vaccine
timeFrame: One month after last dose (Up to Month 13)
measure: Stage II: cLIA GMTs to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age
timeFrame: Up to Month 84
measure: Stage II: cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age
timeFrame: Up to Month 84
Secondary outcomes:
measure: Stage I: cLIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine
timeFrame: One month after last dose (Up to Month 13)
measure: Stage I: Immunoglobulin G Luminex immunoassay (IgG LIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose
timeFrame: One month after last dose (Up to Month 13)
measure: Stage I: IgG LIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine
timeFrame: One month after last dose (Up to Month 13)
measure: Stage I: Percentage of participants experiencing solicited injection-site adverse events (AEs)
timeFrame: Day 1 through Day 8 following any study vaccination
measure: Stage I: Percentage of participants experiencing solicited systemic AEs
timeFrame: Day 1 through Day 8 following any study vaccination
measure: Stage I: Percentage of participants experiencing serious AEs (SAEs) Up to Month 13
timeFrame: Up to Month 13
measure: Stage II: Percentage of participants experiencing SAEs Up to Month 84
timeFrame: Month 18 up to Month 84
measure: Stage II: IgG LIA GMTs to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age
timeFrame: Up to Month 84
measure: Stage II: IgG LIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age
timeFrame: Up to Month 84
Other outcomes:
Locations:
city: Quzhou
country: China
facility: Jiangshan Center for Disease Control and Prevention ( Site 0001)
state: Zhejiang
city: Taizhou
country: China
facility: Yuhuan Center for Disease Control and Prevention ( Site 0002)
state: Zhejiang
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: