Warts, GenitalPhase 3NCT04635423
Efficacy, Immunogenicity, and Safety Study of V503 (9-valent Human Papillomavirus [9vHPV] Vaccine) in Japanese Males (V503-064)
A Phase 3 study testing V503 in people with Warts, Genital and Neoplasms, Anal, run by Merck Sharp & Dohme LLC at 22 sites in Japan.
Trial summary
The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 in preventing human papillomavirus (HPV)-related anogenital persistent infection, and to evaluate the safety/tolerability of V503, in Japanese males who are 16 to 26 years of age. Read more about this study
- Who is it for?
- Ages 16 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Warts, Genital, Neoplasms, Anal
- What is being tested?
- V503
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,059 participants
- Where
- 22 sitesJapan
- Study dates
- 30 Nov 2020to 23 Jul 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 26 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Is a Japanese male 16 to 26 years of age
- Has no more than 5 lifetime sexual partners
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Japan22 sites
P-One Clinic, Keikokai Medical Corp. ( Site 6419)
Hachiōji, Tokyo, 192-0071
Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 6424)
Kawasaki, Kanagawa, 210-0852
Iwasa Clinic ( Site 6411)
Osaka, 542-0073
Nomura Clinic Namba ( Site 6405)
Osaka, 542-0076
Medical Corporation Seiwakai Hayakawa Clinic ( Site 6409)
Osaka, 542-0086
Yamanaka Clinic ( Site 6410)
Osaka, 553-0001
Kanno Clinic ( Site 6402)
Sakai, Osaka, 590-0024
Umeyama Clinic ( Site 6406)
Takasaki, Gunma, 370-0826
Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6404)
Tokyo, 101-0041
Yuge Clinic ( Site 6421)
Tokyo, 103-0014
Taisei Clinic ( Site 6403)
Tokyo, 107-0052
Mildix Skin Clinic ( Site 6423)
Tokyo, 120-0034
Sugisawa Dermatology Clinic ( Site 6422)
Tokyo, 125-0041
Medical Corporation Sanshikai Toru Clinic ( Site 6401)
Tokyo, 132-0011
Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 6418)
Tokyo, 144-0051
Seiyukai Medical Corporation Itoh Skin Clinic ( Site 6416)
Tokyo, 154-0024
Naoko Dermatology Clinic ( Site 6417)
Tokyo, 158-0097
Medical Corporation Iseikai My City Clinic ( Site 6414)
Tokyo, 160-0022
Shinjuku Higashiguchi Clinic ( Site 6415)
Tokyo, 160-0022
Ogikuboekimae Clinic ( Site 6413)
Tokyo, 167-0051
Kusunoki Clinic ( Site 6412)
Tokyo, 175-0092
Ocean Clinic ( Site 6407)
Yokohama, Kanagawa, 231-8331
About this study
Official title: A Phase 3, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9vHPV Vaccine in Japanese Males, 16 to 26 Years of Age.
The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 in preventing human papillomavirus (HPV)-related anogenital persistent infection, and to evaluate the safety/tolerability of V503, in Japanese males who are 16 to 26 years of age. It is hypothesized that administration of a 3-dose regimen of V503 reduces the combined incidence of HPV 6/11/16/18-related anogenital persistent infection, as well as the combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection, compared with placebo.
The study includes a Base Study to assess efficacy and safety of V503, and an Extension Study. Participants who received placebo in the Base Study will be eligible to receive V503 vaccine on Day 1, Month 2, and Month 6 of the Extension Study. Participants who received less than 3 doses of V503 in the Base Study will be offered the opportunity to complete the 3-dose regimen in the Extension Study.
- Conditions
- Warts, Genital, Neoplasms, Anal
- Being tested
- V503, Placebo
- Medical subject headings
- Condylomata Acuminata, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V503Biological
Also called 9vHPV vaccine, SILGARD®9, GARDASIL™9
9-valent vaccine, HPV 6/11/16/18/31/33/45/52/58, L1 virus-like particle (VLP) 30/40/60/40/20/20/20/20/20 mcg per dose.
PlaceboOther
0.9% sodium chloride (NaCL)
| Study group | Role | What they receive |
|---|---|---|
| V503 | Experimental | In the base study, participants receive an intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6. Receives: Biological: V503 |
| Placebo | Placebo comparator | In the base study, participants receive an IM injection of placebo at Day 1, Month 2, and Month 6. Receives: Other: Placebo |
| V503 → Open Label V503 Extension Study | Experimental | Participants from V503 arm of the base study who do not complete the 3-dose series receive 1 or 2 doses of V503, on Day 1, or Day 1 and Month 4 of the open label extension study. Receives: Biological: V503 |
| Placebo → Open Label V503 Extension Study | Experimental | Participants from the placebo arm of the base study receive 3 doses of V503 on Day 1, Month 2 and Month 6 of the open label extension study. Receives: Biological: V503 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Base Study: Combined Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Anogenital Persistent Infection
Combined incidence of HPV type(s) 6/11/16/18-related anogenital persistent infection was defined to have occurred in a participant; 1) who is polymerase chain reaction (PCR) positive to at least one applicable HPV type(s) in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (±1 month visit) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of at least one applicable HPV type(s) in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit with regardless of visit interval, prior to or following the biopsy showing HPV disease. Incidence was defined as the number of cases per 100 person-years of follow-up in both V503 and placebo arms. Per protocol, cases per 100 person-years is reported for applicable HPV type eligible participants with data available in the per-protocol efficacy population (PPE).
Measured: Up to approximately 36 Months
Base Study: Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
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. The participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, tenderness/pain, and swelling) is reported here for all randomized participants in the All Participants as Treated (APaT) population.
Measured: Up to 5 days after any vaccination
Base Study: Percentage of Participants With ≥1 Systemic AE
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. The percentage of participants who experienced at least 1 systemic AE is reported here for all randomized participants in the All Participants as Treated (APaT) population.
Measured: Up to 15 days after any vaccination
Base Study: Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
An SAE 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, that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, results in persistent/significant disability/incapacity, is a congenital birth defect, or is another important medical event. The percentage of participants who experienced at least 1 SAE is reported here for all randomized participants in the All Participants as Treated (APaT) population.
Measured: Up to approximately 37 months
Base Study: Number of Participants With Elevated Oral Body Temperature
Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded using the vaccination report card (VRC). Per protocol, fever was defined as an oral temperature of ≥99.5°F(37.5°C). The number of participants who had at least 1 oral body temperature reading that was, <99.5°F (<37.5ºC), ≥99.5°F (≥37.5ºC) and <100.4°F (38.0°C), or ≥100.4°F (38.0°C) and <101.3°F(38.5°C), or ≥101.3°F(38.5°C) is reported here for all randomized participants in the APaT population with temperature data available.
Measured: Up to 5 days after any vaccination
Secondary outcomes (7)
Base Study: Combined Incidence of HPV 31/33/45/52/58-related Anogenital Persistent Infection
Combined incidence of HPV type(s) 31/33/45/52/58-related anogenital persistent infection was defined to have occurred in a participant; 1) who is polymerase chain reaction (PCR) positive to at least 1 applicable HPV type(s) in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (±1 month visit) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of at least 1 applicable HPV type in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit with regardless of visit interval, prior to or following the biopsy showing HPV disease. Incidence was defined as the number of cases per 100 person-years of follow-up in both V503 and placebo arms. Per protocol, cases per 100 person-years is reported for applicable HPV type(s) eligible participants with data available in the per-protocol efficacy population (PPE).
Measured: Up to approximately 36 Months
Base Study: Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Antibodies to the HPV types 6/11/16/18/31/33/45/52/58 contained in V503 were measured using a competitive Luminex immunoassay (cLIA). Per protocol, antibody titers were expressed as milli Merck units/milliliter (mMU/mL). Geometric Mean Titers (GMTs) is reported for both V503 and Placebo for all randomized participants of the per-protocol immunogenicity population (PPI).
Measured: Month 7
Base Study: Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Antibodies to the HPV types 6/11/16/18/31/33/45/52/58 contained in V503 were measured using a competitive Luminex immunoassay (cLIA). Per protocol, antibody titers were expressed as milli Merck units/milliliter (mMU/mL). Geometric Mean Titers (GMTs) is reported for both V503 and Placebo for the heterosexual males (HM) subgroup of the per-protocol immunogenicity population (PPI).
Measured: Month 7
Base Study: Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Antibodies to the HPV types 6/11/16/18/31/33/45/52/58 contained in V503 were measured using a competitive Luminex immunoassay (cLIA). Per protocol, antibody titers were expressed as milli Merck units/milliliter (mMU/mL). Geometric Mean Titers (GMTs) is reported for both V503 and Placebo for the males who have sex with males (MSM) subgroup of the per-protocol immunogenicity population (PPI).
Measured: Month 7
Base Study: Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Percentage of seroconversion to each of HPV 6/11/16/18/31/33/45/52/58 at Month 7 based on competitive Luminex immunoassay (cLIA) from participant serum samples. Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive at 1 month post last dose Month 7. A participant with anti-HPV cLIA titer at or above the serostatus cutoff values of the cLIA for a given HPV type is considered seropositive for that HPV type. The serostatus cutoffs (milli Merck units/milliliter (mMU/mL)) for HPV types were as follows: HPV Type 6: ≥65, HPV Type 11: ≥37; HPV Type 16: ≥79, HPV Type 18: ≥85, HPV Type 31: ≥46, HPV Type 33: ≥26, HPV Type 45: ≥21, HPV Type 52: ≥30, and HPV Type 58: ≥31. The percentage of participants with seroconversion is reported for both V503 and Placebo for all randomized participants of the per-protocol immunogenicity population (PPI).
Measured: Month 7
Base Study: Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Percentage of seroconversion to each of HPV 6/11/16/18/31/33/45/52/58 at Month 7 based on competitive Luminex immunoassay (cLIA) from participant serum samples. Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive at 1 month post last dose Month 7. A participant with anti-HPV cLIA titer at or above the serostatus cutoff values of the cLIA for a given HPV type is considered seropositive for that HPV type. The serostatus cutoffs (milli Merck units/milliliter (mMU/mL)) for HPV types were as follows: HPV Type 6: ≥65, HPV Type 11: ≥37; HPV Type 16: ≥79, HPV Type 18: ≥85, HPV Type 31: ≥46, HPV Type 33: ≥26, HPV Type 45: ≥21, HPV Type 52: ≥30, and HPV Type 58: ≥31. The percentage of participants with seroconversion is reported for both V503 and Placebo for the heterosexual males (HM) subgroup of the per-protocol immunogenicity population (PPI).
Measured: Month 7
Base Study: Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Percentage of seroconversion to each of HPV 6/11/16/18/31/33/45/52/58 at Month 7 based on competitive Luminex immunoassay (cLIA) from participant serum samples. Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive at 1 month post last dose Month 7. A participant with anti-HPV cLIA titer at or above the serostatus cutoff values of the cLIA for a given HPV type is considered seropositive for that HPV type. The serostatus cutoffs (milli Merck units/milliliter (mMU/mL)) for HPV types were as follows: HPV Type 6: ≥65, HPV Type 11: ≥37; HPV Type 16: ≥79, HPV Type 18: ≥85, HPV Type 31: ≥46, HPV Type 33: ≥26, HPV Type 45: ≥21, HPV Type 52: ≥30, and HPV Type 58: ≥31. The percentage of participants with seroconversion is reported for both V503 and Placebo for the males who have sex with males (MSM) subgroup of the per-protocol immunogenicity population (PPI).
Measured: Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start30 Nov 2020
- Primary completion31 Dec 2023
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Warts, GenitalStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,059 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635423
- Sponsor's protocol ID
- V503-064
- Other IDs
- V503-064, jRCT2031200217, 2020-001047-67
- Status last verified
- May 2026
- First submitted
- 5 Nov 2020
- Last updated
- 11 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Hisamoto K, Yamanaka M, Nomura M, Kanno N, Giuliano AR, Wan K, Fukao Y, Oshima N, Wakana A, Tanaka Y, Luxembourg A, Sawata M. Efficacy, immunogenicity, and safety of the 9-valent human papillomavirus vaccine in males aged 16-26 years in Japan: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2026 Aug 3:S1473-3099(26)00291-4. doi: 10.1016/S1473-3099(26)00291-4. Online ahead of print.
PubMed 42546724Bergman 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.
PubMed 41276263
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9vHPV Vaccine in Japanese Males, 16 to 26 Years of Age.
- ClinicalTrials.gov ID
- NCT04635423
- Acronym / sponsor ID
- V503-064
- Conditions
- Warts, Genital, Neoplasms, Anal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,059 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 in preventing human papillomavirus (HPV)-related anogenital persistent infection, and to evaluate the safety/tolerability of V503, in Japanese males who are 16 to 26 years of age. It is hypothesized that administration of a 3-dose regimen of V503 reduces the combined incidence of HPV 6/11/16/18-related anogenital persistent infection, as well as the combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection, compared with placebo.
The study includes a Base Study to assess efficacy and safety of V503, and an Extension Study. Participants who received placebo in the Base Study will be eligible to receive V503 vaccine on Day 1, Month 2, and Month 6 of the Extension Study. Participants who received less than 3 doses of V503 in the Base Study will be offered the opportunity to complete the 3-dose regimen in the Extension Study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| V503 | Experimental | Biological: V503In the base study, participants receive an intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6. |
| Placebo | Placebo comparator | Other: PlaceboIn the base study, participants receive an IM injection of placebo at Day 1, Month 2, and Month 6. |
| V503 → Open Label V503 Extension Study | Experimental | Biological: V503Participants from V503 arm of the base study who do not complete the 3-dose series receive 1 or 2 doses of V503, on Day 1, or Day 1 and Month 4 of the open label extension study. |
| Placebo → Open Label V503 Extension Study | Experimental | Biological: V503Participants from the placebo arm of the base study receive 3 doses of V503 on Day 1, Month 2 and Month 6 of the open label extension study. |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Is a Japanese male 16 to 26 years of age
- Has no more than 5 lifetime sexual partners
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V503Also: 9vHPV vaccine, SILGARD®9, GARDASIL™99-valent vaccine, HPV 6/11/16/18/31/33/45/52/58, L1 virus-like particle (VLP) 30/40/60/40/20/20/20/20/20 mcg per dose. | Biological | Placebo → Open Label V503 Extension Study, V503, V503 → Open Label V503 Extension Study |
| Placebo0.9% sodium chloride (NaCL) | Other | Placebo |
Primary outcome
Base Study: Combined Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Anogenital Persistent Infection
Time frame: Up to approximately 36 Months
Combined incidence of HPV type(s) 6/11/16/18-related anogenital persistent infection was defined to have occurred in a participant; 1) who is polymerase chain reaction (PCR) positive to at least one applicable HPV type(s) in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (±1 month visit) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of at least one applicable HPV type(s) in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit with regardless of visit interval, prior to or following the biopsy showing HPV disease. Incidence was defined as the number of cases per 100 person-years of follow-up in both V503 and placebo arms. Per protocol, cases per 100 person-years is reported for applicable HPV type eligible participants with data available in the per-protocol efficacy population (PPE).
Base Study: Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
Time frame: Up to 5 days after any vaccination
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. The participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, tenderness/pain, and swelling) is reported here for all randomized participants in the All Participants as Treated (APaT) population.
Base Study: Percentage of Participants With ≥1 Systemic AE
Time frame: Up to 15 days after any vaccination
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. The percentage of participants who experienced at least 1 systemic AE is reported here for all randomized participants in the All Participants as Treated (APaT) population.
Base Study: Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
Time frame: Up to approximately 37 months
An SAE 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, that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, results in persistent/significant disability/incapacity, is a congenital birth defect, or is another important medical event. The percentage of participants who experienced at least 1 SAE is reported here for all randomized participants in the All Participants as Treated (APaT) population.
Base Study: Number of Participants With Elevated Oral Body Temperature
Time frame: Up to 5 days after any vaccination
Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded using the vaccination report card (VRC). Per protocol, fever was defined as an oral temperature of ≥99.5°F(37.5°C). The number of participants who had at least 1 oral body temperature reading that was, <99.5°F (<37.5ºC), ≥99.5°F (≥37.5ºC) and <100.4°F (38.0°C), or ≥100.4°F (38.0°C) and <101.3°F(38.5°C), or ≥101.3°F(38.5°C) is reported here for all randomized participants in the APaT population with temperature data available.
7 secondary outcomes
Base Study: Combined Incidence of HPV 31/33/45/52/58-related Anogenital Persistent Infection
Time frame: Up to approximately 36 Months
Base Study: Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Time frame: Month 7
Base Study: Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Time frame: Month 7
Base Study: Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Time frame: Month 7
Base Study: Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants
Time frame: Month 7
Base Study: Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup
Time frame: Month 7
Base Study: Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup
Time frame: Month 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42546724Hisamoto K, Yamanaka M, Nomura M, Kanno N, Giuliano AR, Wan K, Fukao Y, Oshima N, Wakana A, Tanaka Y, Luxembourg A, Sawata M. Efficacy, immunogenicity, and safety of the 9-valent human papillomavirus vaccine in males aged 16-26 years in Japan: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2026 Aug 3:S1473-3099(26)00291-4. doi: 10.1016/S1473-3099(26)00291-4. Online ahead of print.
- Derived from this study: PubMed 41276263Bergman 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.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Efficacy and Safety of Oral Ivermectin for Genital Warts
Genital Warts
RecruitingPhase 2
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
HPV (Human Papillomavirus)-Associated, Genital Warts
Not yet recruitingPhase 3
Intralesional Acyclovir Versus Intralesional Zinc Sulphate in the Treatment of Plantar Warts
Warts, Plantar Warts
RecruitingObservational study
Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
Psoriasis, Condyloma Acuminata
Not yet recruitingEarly Phase 1
the Efficacy of Ivermectin Alone or With Microneedling in Treatment of Cutaneous Warts.
Warts
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing V503 in people with Warts, Genital and Neoplasms, Anal, run by Merck Sharp & Dohme LLC at 22 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Base Study: Combined Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Anogenital Persistent Infection (time frame: Up to approximately 36 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04635423, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.