NCT05450705

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for phase_3

Timeline
40mo left

Started Jul 2022

Longer than P75 for phase_3

Geographic Reach
1 country

2 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 Progress54%
Jul 2022Aug 2029

First Submitted

Initial submission to the registry

June 28, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

July 22, 2022

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2029

Last Updated

September 2, 2022

Status Verified

September 1, 2022

Enrollment Period

7 years

First QC Date

June 28, 2022

Last Update Submit

September 1, 2022

Conditions

Papillomavirus Infections

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

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

    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

    One month after last dose (Up to Month 13)

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

    One month after last dose (Up to Month 13)

  • Stage I: Percentage of participants experiencing solicited injection-site adverse events (AEs)

    Day 1 through Day 8 following any study vaccination

  • Stage I: Percentage of participants experiencing solicited systemic AEs

    Day 1 through Day 8 following any study vaccination

  • +4 more secondary outcomes

Study Arms (3)

9 to 14 Years Old: Day 1 and Month 6

EXPERIMENTAL

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

9 to 14 Years Old: Day 1 and Month 12

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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, GARDASIL9™
20 to 26 Years Old: Day 1, Month 2 and Month 69 to 14 Years Old: Day 1 and Month 129 to 14 Years Old: Day 1 and Month 6

Eligibility Criteria

Age9 Years - 26 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jiangshan Center for Disease Control and Prevention ( Site 0001)

Quzhou, Zhejiang, 324100, China

Location

Yuhuan Center for Disease Control and Prevention ( Site 0002)

Taizhou, Zhejiang, 317600, China

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital 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
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2022

First Posted

July 11, 2022

Study Start

July 22, 2022

Primary Completion (Estimated)

August 3, 2029

Study Completion (Estimated)

August 3, 2029

Last Updated

September 2, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

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

More information

Locations

CN(2)