Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066)

NCT ID: NCT04772534

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-17
• Study Completion Date: 2024-04-06

Brief Summary

The primary objective of this study is the estimation of the human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58 seroconversion at 1 month post last dose (Month 7) following 3 doses and 2 doses of the 9-valent human papillomavirus (9vHPV) vaccine. No hypothesis will be tested since this study is an estimation-only study.

Conditions

Papillomavirus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

3-dose in 9 to 15 year old boys

9 to 15 year old boys will receive a 3-dose regimen of 9vHPV vaccine (Day 1, Month 2 and Month 6).

Group Type: EXPERIMENTAL

9vHPV vaccine

Intervention Type: BIOLOGICAL

9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection

2-dose in 9 to 14 year old boys

9 to 14 year old boys receive a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).

Group Type: EXPERIMENTAL

9vHPV vaccine

Intervention Type: BIOLOGICAL

9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection

2-dose in 9 to 14 year old girls

9 to 14 year old girls receive a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).

Group Type: EXPERIMENTAL

9vHPV vaccine

Intervention Type: BIOLOGICAL

9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection

Interventions

9vHPV vaccine

9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection

Intervention Type: BIOLOGICAL

Other Intervention Names

V503; SILGARD®9; GARDASIL™9

Eligibility Criteria

Inclusion Criteria

• Is Japanese male or female.
• Is aged at the time of providing the documented informed consent (inclusive): (3-dose boy arm) male from 9 years to 15 years old, (2-dose boy arm) male from 9 years to 14 years old, or (2-dose girl arm) female from 9 years to 14 years old.
• Has a legally acceptable representative who can read, understand and complete the vaccination report card (VRC).
• Has not yet had coitarche and does not plan on becoming sexually active during the Day 1 through Month 7.

Exclusion Criteria

• Has a fever (defined as oral temperature ≥37.5°C) within the 24-hour period prior to the Day 1 visit.
• Has a history of severe allergic reaction that required medical intervention.
• Is allergic to any vaccine component, including aluminum, yeast, or Benzonase™.
• Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
• Is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other auto immune condition.
• Has a history of splenectomy.
• Has a history of genital warts or positive test for human papillomavirus (HPV).
• Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within 12 months) of drug or alcohol abuse or dependence at the discretion of the investigator. .
• Has received within 12 months prior to enrollment, is receiving, or plans to receive during Day 1 through Month 7 of the study, any study-prohibited concomitant immunosuppressive therapy .
• Has received within the 3 months prior to the Day 1 vaccination, is receiving, or plans to receive during Day 1 through Month 7 of the study, any immune globulin product or blood-derived product other than intravenous gamma globulin (IVIG).
• Has received inactivated or recombinant vaccines within 14 days prior to Day 1 vaccination or receipt of live vaccines within 28 days prior to Day 1 vaccination.
• Has previously received a marketed HPV vaccine or has participated in a clinical trial for any HPV vaccine (receiving either active agent or placebo).
• Is concurrently enrolled in other clinical studies of investigational agents.
• Is unlikely to adhere to the study procedures, keep appointments, or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period when study visits would need to be scheduled.
• Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Sotobo Children's Clinic ( Site 6616)

Isumi, Chiba, Japan

Ohigesenseino Kodomo Clinic ( Site 6607)

Sapporo, Hokkaido, Japan

Motomachi Pediatric Clinic ( Site 6606)

Sapporo, Hokkaido, Japan

Medical Corporation Bunmeikai Okuda E.N.T ( Site 6611)

Sakai, Osaka, Japan

Fukui General Hospital ( Site 6614)

Fukui, , Japan

Nomura Clinic Namba ( Site 6608)

Osaka, , Japan

Medical Corporation Kanyukai Kikumori Otolaryngology Clinic ( Site 6612)

Osaka, , Japan

Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6603)

Tokyo, , Japan

Okawa Children & Family Clinic ( Site 6610)

Tokyo, , Japan

Shinjuku Higashiguchi Clinic ( Site 6602)

Tokyo, , Japan

Hayashi Clinic ( Site 6615)

Tokyo, , Japan

Ogikuboekimae Clinic ( Site 6601)

Tokyo, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

V503-066

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2031210080

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-001170-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V503-066

Identifier Type: -

Identifier Source: org_study_id