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HPV vaccine shows promise for japanese men in landmark trial

NCT ID NCT04635423

Vaccine Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 study tested the 9-valent HPV vaccine (Gardasil 9) in over 1,000 Japanese males aged 16 to 26. The goal was to see if the vaccine could prevent persistent HPV infections that can lead to genital warts and anal cancers. Participants received either the vaccine or a placebo, and the study tracked infections and side effects over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
9-valent HPV vaccine (Gardasil 9)
What this could lead to
If successful, this could confirm that the 9vHPV vaccine effectively prevents HPV infections and related diseases in Japanese males, supporting its use in this population.
What could go wrong
The trial is completed, but results may not apply to all males or other populations. Some participants may experience injection-site reactions or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,059 people

The number who actually took part.

Started

Nov 2020

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 26 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Is a Japanese male 16 to 26 years of age * Has no more than 5 lifetime sexual partners Exclusion Criteria: * Has a history of known prior vaccination with an HPV vaccine or plans to receive one outside the study * Has a history of external genital warts * Has a history of severe allergic reaction that required medical intervention * Has received immune globulin or blood-derived products in the past 3 months or plan to receive any before Month 7 of the study * 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 intramuscular injections * Has ongoing alcohol or drug abuse within the past 12 months

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Conditions

The condition(s) this trial relates to.

anogenital human papillomavirus infection anus neoplasm human papilloma virus infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoplasms, anal Warts, genital

Contacts and locations

Locations

  • Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 6424)

    Kawasaki, Kanagawa, 210-0852, Japan

  • Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6404)

    Tokyo, 101-0041, Japan

  • Iwasa Clinic ( Site 6411)

    Osaka, 542-0073, Japan

  • Kanno Clinic ( Site 6402)

    Sakai, Osaka, 590-0024, Japan

  • Kusunoki Clinic ( Site 6412)

    Tokyo, 175-0092, Japan

  • Medical Corporation Iseikai My City Clinic ( Site 6414)

    Tokyo, 160-0022, Japan

  • Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 6418)

    Tokyo, 144-0051, Japan

  • Medical Corporation Sanshikai Toru Clinic ( Site 6401)

    Tokyo, 132-0011, Japan

  • Medical Corporation Seiwakai Hayakawa Clinic ( Site 6409)

    Osaka, 542-0086, Japan

  • Mildix Skin Clinic ( Site 6423)

    Tokyo, 120-0034, Japan

  • Naoko Dermatology Clinic ( Site 6417)

    Tokyo, 158-0097, Japan

  • Nomura Clinic Namba ( Site 6405)

    Osaka, 542-0076, Japan

  • Ocean Clinic ( Site 6407)

    Yokohama, Kanagawa, 231-8331, Japan

  • Ogikuboekimae Clinic ( Site 6413)

    Tokyo, 167-0051, Japan

  • P-One Clinic, Keikokai Medical Corp. ( Site 6419)

    Hachiōji, Tokyo, 192-0071, Japan

  • Seiyukai Medical Corporation Itoh Skin Clinic ( Site 6416)

    Tokyo, 154-0024, Japan

  • Shinjuku Higashiguchi Clinic ( Site 6415)

    Tokyo, 160-0022, Japan

  • Sugisawa Dermatology Clinic ( Site 6422)

    Tokyo, 125-0041, Japan

  • Taisei Clinic ( Site 6403)

    Tokyo, 107-0052, Japan

  • Umeyama Clinic ( Site 6406)

    Takasaki, Gunma, 370-0826, Japan

  • Yamanaka Clinic ( Site 6410)

    Osaka, 553-0001, Japan

  • Yuge Clinic ( Site 6421)

    Tokyo, 103-0014, Japan

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Other studies related to the condition(s) this trial covers.