NCT05314023

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,590

participants targeted

Target at P75+ for phase_3

Timeline
34mo left

Started May 2022

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
May 2022Feb 2029

First Submitted

Initial submission to the registry

March 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 7, 2022

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2029

Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

6.8 years

First QC Date

March 29, 2022

Last Update Submit

January 18, 2023

Conditions

Genital Warts

Outcome Measures

Primary Outcomes (3)

  • Competitive Luminex immunoassay (cLIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose

    cLIA 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.

    Up to Month 13

  • cLIA GMTs to 9 vaccine types of 9vHPV vaccine up to 60 months post last dose

    cLIA GMT to each of 9 vaccine types of 9vHPV vaccine at up to 60 months post last dose. The GMT for each HPV type will be reported in mMU/mL.

    Up to 72 months

  • cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine

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

    Up to 72 months

Secondary Outcomes (8)

  • cLIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine

    Up to Month 13

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

    Up to Month 13

  • IgG LIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine

    Up to Month 13

  • Percentage of participants experiencing solicited injection-site adverse events (AEs),

    Day 1 through Day 8 following any study vaccination

  • Percentage of participants experiencing solicited systemic AEs

    Day 1 through Day 8 following any study vaccination

  • +3 more secondary outcomes

Study Arms (3)

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

EXPERIMENTAL

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

Biological: 9vHPV vaccine

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

EXPERIMENTAL

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

Biological: 9vHPV vaccine

9 to 14 Years Old: Day 1 and Month 12

EXPERIMENTAL

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

Biological: 9vHPV vaccine

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.

Also known as: V503, GARDASIL™9
9 to 14 Years Old: Day 1 and Month 129 to 14 Years Old: Day 1, and Month 69 to 19 Years Old: Day 1, Months 2 and 6

Eligibility Criteria

Age9 Years - 19 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsChinese males only
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Liucheng County Centers for Disease Control and Prevention ( Site 0005)

Liuchow, Guangxi, 545200, China

Location

Center for Disease Control and Prevention of Rong An ( Site 0006)

Liuchow, Guangxi, 545400, China

Location

Loudi Public Health Hospital (Loudi Occupational Disease Prevention And Treatment Hospital) ( Site 0

Louxing District, Hunan, 417000, China

Location

Yuechi Disease Prevention and Control Center ( Site 0002)

Guang’an, Sichuan, 638399, China

Location

Santai County Center for Disease Control and Prevention ( Site 0001)

Mianyang, Sichuan, 621100, China

Location

MeSH Terms

Conditions

Condylomata Acuminata

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralTumor Virus InfectionsGenital DiseasesUrogenital DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 6, 2022

Study Start

May 7, 2022

Primary Completion (Estimated)

February 19, 2029

Study Completion (Estimated)

February 19, 2029

Last Updated

January 19, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

More information

Locations

CN(5)