Papillomavirus InfectionsPhase 3NCT04772534

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

A Phase 3 study testing 9vHPV vaccine in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC at 12 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 9 to 15 yearsHealthy volunteers can take part
Conditions the study is for: Papillomavirus Infections
What is being tested?: 9vHPV vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 314 participants
Where: 12 sitesJapan
Study dates: 17 May 2021to 6 Apr 2024
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 9 to 15 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Japan12 sites

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

Other trials in Japan

About this study

Official title: 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.

Conditions: Papillomavirus Infections
Being tested: 9vHPV vaccine
Medical subject headings: Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

9vHPV vaccineBiological
Also called V503, SILGARD®9, GARDASIL™9
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection

Study groups in NCT04772534
Study group	Role	What they receive
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). Receives: 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). Receives: 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). Receives: Biological: 9vHPV vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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).
Measured: 1 month after final dose (Month 7)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 May 20216 Apr 2024

First posted26 Feb 2021
Study start17 May 2021
Primary completion6 Apr 2024
Study completion6 Apr 2024

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 (1)Papers the sponsor has linked to this study.
Other trials for Papillomavirus InfectionsStudies 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: None (open label)
Enrolment: 314 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04772534
Sponsor's protocol ID: V503-066
Other IDs: V503-066, jRCT2031210080, 2020-001170-29
Status last verified: May 2025
First submitted: 23 Feb 2021
Last updated: 30 May 2025
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

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.
PubMed 41276263

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Papillomavirus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT04772534
Acronym / sponsor ID: V503-066
Conditions: Papillomavirus Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 314 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 17 May 2021 (actual)
Primary completion: 6 Apr 2024 (actual)
Study completion: 6 Apr 2024 (actual)
First posted: 26 Feb 2021 (actual)
Results: Posted 30 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
3-dose in 9 to 15 year old boys	Experimental	Biological: 9vHPV vaccine9 to 15 year old boys will receive a 3-dose regimen of 9vHPV vaccine (Day 1, Month 2 and Month 6).
2-dose in 9 to 14 year old boys	Experimental	Biological: 9vHPV vaccine9 to 14 year old boys receive a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
2-dose in 9 to 14 year old girls	Experimental	Biological: 9vHPV vaccine9 to 14 year old girls receive a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).

Who may qualify

Ages: 9 to 15 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (15 listed)

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.

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
9vHPV vaccineAlso: V503, SILGARD®9, GARDASIL™99-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection	Biological	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

Primary outcome

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.
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.
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.
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.

1 secondary outcome

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)

Results and safety

Results posted to the registry on 30 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3-Dose Regimen: 9 to 15 Year Old Boys	105	101
2-dose Regimen: 9 to 14 Year Old Boys	104	104
2-dose Regimen: 9 to 14 Year Old Girls	105	104

Primary outcome: 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). Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	3-Dose Regimen: 9 to 15 Year Old Boys n = 103	2-dose Regimen: 9 to 14 Year Old Boys n = 104	2-dose Regimen: 9 to 14 Year Old Girls n = 104
Anti-HPV 6	100.0 (96.0 to 100.0)	100.0 (96.0 to 100.0)	100.0 (96.1 to 100.0)
Anti-HPV 11	100.0 (96.0 to 100.0)	100.0 (96.0 to 100.0)	100.0 (96.1 to 100.0)
Anti-HPV 16	100.0 (96.3 to 100.0)	100.0 (96.3 to 100.0)	100.0 (96.3 to 100.0)
Anti-HPV 18	100.0 (96.2 to 100.0)	100.0 (96.1 to 100.0)	100.0 (95.7 to 100.0)
Anti-HPV 31	100.0 (96.0 to 100.0)	100.0 (96.1 to 100.0)	100.0 (96.0 to 100.0)
Anti-HPV 33	100.0 (95.8 to 100.0)	100.0 (96.0 to 100.0)	100.0 (96.2 to 100.0)
Anti-HPV 45	100.0 (96.2 to 100.0)	100.0 (96.2 to 100.0)	100.0 (96.3 to 100.0)
Anti-HPV 52	100.0 (96.3 to 100.0)	100.0 (96.2 to 100.0)	100.0 (96.3 to 100.0)

Population analysed: All participants who received all 9vHPV vaccinations at the correct dose and day range, have provided blood samples for serology within 21 to 49 days of the last dose, are seronegative to the appropriate HPV type(s) at Day 1, and had no protocol violations that could interfere with immune response, are included.

Primary outcome: 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). Count of participants. Unit: Participants

Measure	3-Dose Regimen: 9 to 15 Year Old Boys n = 103	2-dose in 9 to 14 Year Old Boys n = 104	2-dose in 9 to 14 Year Old Girls n = 104
Value	87	85	92

Population analysed: All treated participants are included.

Primary outcome: Number of Participants With at Least 1 Systemic Adverse Event

Time frame: Up to 15 days after each vaccination (up to ~6.5 months). Count of participants. Unit: Participants

Measure	3-Dose Regimen: 9 to 15 Year Old Boys n = 103	2-dose in 9 to 14 Year Old Boys n = 104	2-dose in 9 to 14 Year Old Girls n = 104
Value	55	41	33

Population analysed: All treated participants are included.

Primary outcome: Number of Participants With at Least 1 Serious Adverse Event (SAE)

Time frame: Up to ~Month 30. Count of participants. Unit: Participants

Measure	3-Dose Regimen: 9 to 15 Year Old Boys n = 103	2-dose Regimen: 9 to 14 Year Old Boys n = 104	2-dose Regimen: 9 to 14 Year Old Girls n = 104
Value	0	2	3

Population analysed: All treated participants are included.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to ~Month 30. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3-Dose Regimen: 9 to 15 Year Old Boys	0 of 103 (0%)	18 of 103 (17.5%)	0 of 103
2-dose Regimen: 9 to 14 Year Old Boys	2 of 104 (1.9%)	12 of 104 (11.5%)	0 of 104
2-dose Regimen: 9 to 14 Year Old Girls	3 of 104 (2.9%)	8 of 104 (7.7%)	0 of 104

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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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

12 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 9vHPV vaccine in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC at 12 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 4 inclusion and 15 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 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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. 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 30 May 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?

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 study lists 4 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 NCT04772534, which also lists 1 linked publication.

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 30 May 2025.