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

May 29, 2025 updated by: Merck Sharp & Dohme LLC

A Phase 3, Open-label Clinical Study to Evaluate the Immunogenicity and Safety of 9vHPV Vaccine, in Japanese Boys and Girls, 9 to 15 Years of Age.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
314

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukui, Japan, 910-8561
        • Fukui General Hospital ( Site 6614)
      • Osaka, Japan, 542-0076
        • Nomura Clinic Namba ( Site 6608)
      • Osaka, Japan, 554-0014
        • Medical Corporation Kanyukai Kikumori Otolaryngology Clinic ( Site 6612)
      • Tokyo, Japan, 101-0041
        • Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6603)
      • Tokyo, Japan, 146-0095
        • Okawa Children & Family Clinic ( Site 6610)
      • Tokyo, Japan, 160-0022
        • Shinjuku Higashiguchi Clinic ( Site 6602)
      • Tokyo, Japan, 167-0051
        • Hayashi Clinic ( Site 6615)
      • Tokyo, Japan, 167-0051
        • Ogikuboekimae Clinic ( Site 6601)
    • Chiba
      • Isumi-shi, Chiba, Japan, 299-4503
        • Sotobo Children's Clinic ( Site 6616)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 062-0907
        • Ohigesenseino Kodomo Clinic ( Site 6607)
      • Sapporo, Hokkaido, Japan, 065-0024
        • Motomachi Pediatric Clinic ( Site 6606)
    • Osaka
      • Sakai, Osaka, Japan, 593-8322
        • Medical Corporation Bunmeikai Okuda E.N.T ( Site 6611)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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).
Biological: 9vHPV vaccine
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Other Names:
  • V503
  • SILGARD®9
  • GARDASIL™9
Experimental: 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).
Biological: 9vHPV vaccine
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Other Names:
  • V503
  • SILGARD®9
  • GARDASIL™9
Experimental: 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).
Biological: 9vHPV vaccine
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Other Names:
  • V503
  • SILGARD®9
  • GARDASIL™9

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Time Frame: 1 month after final dose (Month 7)
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)
Time Frame: Up to 5 days after each vaccination (up to ~6 months)
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
Time Frame: Up to 15 days after each vaccination (up to ~6.5 months)
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)
Time Frame: Up to ~Month 30
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Time Frame: 1 month after final dose (Month 7)
The GMT for each HPV serotype is presented. Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using competitive Luminex Immunoassay (cLIA).
1 month after final dose (Month 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V503-066 (Other Identifier: MSD)
  • jRCT2031210080 (Registry Identifier: jRCT)
  • 2020-001170-29 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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