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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Papillomavirus Infections
• Intervention / Treatment: Biological: 9vHPV vaccine

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Quzhou, Zhejiang, China, 324100
      • Jiangshan Center for Disease Control and Prevention ( Site 0001)
    • Taizhou, Zhejiang, China, 317600
      • Yuhuan Center for Disease Control and Prevention ( Site 0002)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 9 to 14 Years Old: Day 1 and Month 6; 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	Biological: 9vHPV vaccine; 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.; Other Names: V503; GARDASIL9™
Experimental: 9 to 14 Years Old: Day 1 and Month 12; 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	Biological: 9vHPV vaccine; 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.; Other Names: V503; GARDASIL9™
Experimental: 20 to 26 Years Old: Day 1, Month 2 and Month 6; 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	Biological: 9vHPV vaccine; 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.; Other Names: V503; GARDASIL9™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Up to Month 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	One month after last dose (Up to Month 13)
Stage I: Percentage of participants experiencing solicited injection-site adverse events (AEs)	An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Solicited injection-site AEs such as erythema, swelling, pain, and induration at the injection site will be recorded.	Day 1 through Day 8 following any study vaccination
Stage I: Percentage of participants experiencing solicited systemic AEs	An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Systemic AEs are those not categorized as injection-site AEs.	Day 1 through Day 8 following any study vaccination
Stage I: Percentage of participants experiencing serious AEs (SAEs) Up to Month 13	A SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.	Up to Month 13
Stage II: Percentage of participants experiencing SAEs Up to Month 84	A SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.	Month 18 up to Month 84
Stage II: IgG LIA GMTs to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age	IgG LIA 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.	Up to Month 84
Stage II: IgG LIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age	IgG LIA 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	Up to Month 84

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Anticipated): August 3, 2029
• Study Completion (Anticipated): August 3, 2029

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Tumor Virus Infections; Papillomavirus Infections
• Other Study ID Numbers: V503-071 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes