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

NCT04772534 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: V503-066jRCT20312100802020-001170-29
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 12

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

Outcome Measures

Primary Outcomes (4)

• Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

  The percentage of seropositive participants is reported. Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using competitive Luminex Immunoassay (cLIA). Seroconversion was defined as changing serostatus from seronegative at Day 1 to seropositive at 4 weeks post last vaccination.

  1 month after final dose (Month 7)

• Number of Participants With at Least 1 Injection-site Adverse Event (AE)

  The number of participants with injection-site AEs (erythema/redness, pain and swelling) is reported. An AE any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  Up to 5 days after each vaccination (up to ~6 months)

• Number of Participants With at Least 1 Systemic Adverse Event

  The number of participants with a systemic AE is reported. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  Up to 15 days after each vaccination (up to ~6.5 months)

• Number of Participants With at Least 1 Serious Adverse Event (SAE)

  The number of participants with an SAE is reported. An SAE is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention.

  Up to ~Month 30

Secondary Outcomes (1)

• Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

  1 month after final dose (Month 7)

Study Arms (3)

3-dose in 9 to 15 year old boys

EXPERIMENTAL

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

Biological: 9vHPV vaccine

2-dose in 9 to 14 year old boys

EXPERIMENTAL

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

Biological: 9vHPV vaccine

2-dose in 9 to 14 year old girls

EXPERIMENTAL

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

Biological: 9vHPV vaccine

Interventions

9vHPV vaccine BIOLOGICAL

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

Also known as: V503, SILGARD®9, GARDASIL™9

2-dose in 9 to 14 year old boys; 2-dose in 9 to 14 year old girls; 3-dose in 9 to 15 year old boys

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (12)

Sotobo Children's Clinic ( Site 6616)

Isumi, Chiba, 299-4503, Japan

Location

Ohigesenseino Kodomo Clinic ( Site 6607)

Sapporo, Hokkaido, 062-0907, Japan

Location

Motomachi Pediatric Clinic ( Site 6606)

Sapporo, Hokkaido, 065-0024, Japan

Location

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

Sakai, Osaka, 593-8322, Japan

Location

Fukui General Hospital ( Site 6614)

Fukui, 910-8561, Japan

Location

Nomura Clinic Namba ( Site 6608)

Osaka, 542-0076, Japan

Location

Medical Corporation Kanyukai Kikumori Otolaryngology Clinic ( Site 6612)

Osaka, 554-0014, Japan

Location

Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6603)

Tokyo, 101-0041, Japan

Location

Okawa Children & Family Clinic ( Site 6610)

Tokyo, 146-0095, Japan

Location

Shinjuku Higashiguchi Clinic ( Site 6602)

Tokyo, 160-0022, Japan

Location

Hayashi Clinic ( Site 6615)

Tokyo, 167-0051, Japan

Location

Ogikuboekimae Clinic ( Site 6601)

Tokyo, 167-0051, Japan

Location

Related Publications (1)

• Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

  PMID: 41276263 DERIVED

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: February 23, 2021
• First Posted: February 26, 2021
• Study Start: May 17, 2021
• Primary Completion: April 6, 2024
• Study Completion: April 6, 2024
• Last Updated: May 30, 2025
• Results First Posted: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

JP (12)