A Phase 3 interventional study of 9vHPV Vaccine and Placebo (Saline for Injection) in Papillomavirus Infections, sponsored by Merck Sharp & Dohme LLC. Active, not recruiting at 103 sites in 16 countries. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Prevention
Among 31 studies testing Human Papillomavirus Recombinant Vaccine nonavalent in Papillomavirus Infections — 10 open to participants now, 20 under way, 8 of them phase 3. Human Papillomavirus Recombinant Vaccine nonavalent · Papillomavirus Infections.
Among the 31 studies testing Human Papillomavirus Recombinant Vaccine nonavalent in Papillomavirus Infections, this one is the 5th largest by enrollment, is one of 3 that started in 2020, is one of 16 in phase 3, reaches primary completion later than 10 of the 19 other live ones, and was the 12th registered.
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
Browse Papillomavirus Infections studies →10 of the 31 studies testing Human Papillomavirus Recombinant Vaccine nonavalent in Papillomavirus Infections are open now, in 9 countries. Recruiting first, the newest first:
Merck Sharp & Dohme LLC · Sites in China
Ages 10–45 · Women only · Healthy volunteers
Indiana University · Sites in Kenya
Ages 9–49 · Women only · Healthy volunteers
Western Institute for Veterans Research · Sites in United States
Ages 18+
Talia Sainz Costa · Sites in Spain
Ages 9–18 · Healthy volunteers
Louisiana State University Health Sciences Center in New Orleans · Sites in United States
Ages 18–65 · Healthy volunteers
By country, each count listing its studies:
Human Papillomavirus Recombinant Vaccine nonavalent: first FDA approval 2014 (Gardasil 9). What it is approved for, and how studies give it, is on its page →
Of the 85 Papillomavirus Infections studies recruiting now, 38 (45%) set no upper age limit and 42 (49%) stop at 75 or younger; 19 take children under 18; 36 take healthy volunteers.
This study: 20 Years to 45 Years · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
31 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 4 · Phase 3 17 · Phase 4 10
First in 2009; this study’s year is marked. 3 started in 2020.
This study's enrollment of 6,033 is above the median of 235 across 402 interventional studies indexed under Papillomavirus Infections.
Median enrollment 700 across the 31 interventional studies. Of the 11 that completed or were terminated, 11 (100%) have results posted.
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16 of 31 have an industry lead sponsor. The 10 most frequent:
This study is registered under Merck Sharp & Dohme LLC, one of the names counted as Merck & Co., Inc. Under that name alone:
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 502 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
38 studies in Papillomavirus Infections by Merck & Co., Inc: 1 open now, 7 under way, 6 of them phase 3. Of 30 finished, 26 (87%) have results posted.
Among the 38 studies in Papillomavirus Infections by Merck & Co., Inc, this one is the 3rd largest by enrollment of the 32 interventional ones that give a count, is the only one that started in 2020, is one of 26 in phase 3, and was the 32nd registered.
Merck & Co., Inc’s Papillomavirus Infections studies by the year they started, since 2000.
3 of the studies testing Human Papillomavirus Recombinant Vaccine nonavalent in Papillomavirus Infections that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04199689Phase 3Merck Sharp & Dohme LLCEfficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049) | 2027-01-15 |
| NCT04206813Boston Medical CenterAn Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen | 2026-12 |
| NCT07303751Institut d'Investigació Biomèdica de BellvitgeStudy Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV | 2027-02-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 31 studies testing Human Papillomavirus Recombinant Vaccine nonavalent in Papillomavirus Infections, from their registry updates:
Among Merck & Co., Inc’s 38 in Papillomavirus Infections:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9vHPV vaccine in men 20 to 45 years of age. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of human papillomavirus (HPV) 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo.
There will also be an Extension Study to offer an opportunity to complete the 3 dose regimen of 9vHPV vaccine for participants who received placebo in the Base Study, or received less than 3 doses of 9vHPV vaccine in the Base Study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Base Study:
Extension Study:
Exclusion Criteria:
Base Study:
Extension Study:
- Participants must be excluded from the Extension Study if Base Study Exclusion Criteria #4, 5, 6, 7, 10, 16, or 18 are met
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6
Biological: 9vHPV Vaccine
Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6
Other: Placebo (Saline for Injection)
9vHPV is an aluminum-adjuvanted recombinant protein vaccine prepared from the highly purified virus-like particles of the recombinant major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 given as a 0.5 mL intramuscular injection.
Also known as: GARDASIL®9, V503
0.9% sodium chloride given as a 0.5-mL intramuscular injection
Incidence of HPV 16/18/31/33/45/52/58-related 6-month Persistent Oral Infection
A 6-month persistent infection is defined to have occurred if a participant, after completion of the Month 7 visit, is positive for the same HPV type by the HPV polymerase chain reaction (PCR) assay to at least 1 common gene in Oral Rinse and Gargle (ORG) samples obtained at 2 or more consecutive visits at 6 months (+/-1 month visit window) apart.
Time frame: Up to Month 90
Incidence of HPV 6/11-related 6-month Persistent Oral Infection
A 6-month persistent infection is defined to have occurred if a participant, after completion of the Month 7 visit, is positive for the same HPV type by the HPV PCR assay to at least 1 common gene in ORG samples obtained at 2 or more consecutive visits at 6 months (+/-1 month visit window) apart.
Time frame: Up to Month 90
Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Antibodies
Serum antibodies to HPV types are measured with competitive Luminex immunoassay (cLIA). Geometric mean titers of antibodies to HPV types will be calculated by exponentiating the mean estimates of natural logarithm of the anti-HPV titers.
Time frame: 1 month postdose 3 (Month 7)
Percentage of Participants who Seroconvert to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive by 4 weeks postdose 3. A participant with anti-HPV cLIA titer at or above the serostatus cutoff of the cLIA for a given HPV type is considered seropositive for that HPV type.
Time frame: 1 month postdose 3 (Month 7)
Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Solicited injection-site AEs such as redness/erythema, swelling, and tenderness/pain at the injection site will be recorded.
Time frame: Up to 5 days after any vaccination
Percentage of Participants with Elevated Temperature (Fever)
Participants are asked to record oral body temperatures. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) will be assessed.
Time frame: Up to 5 days after any vaccination
Percentage of Participants Who Report at Least 1 Systemic AE
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs.
Time frame: Up to 15 days after any vaccination
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is another important medical event deemed such by medical or scientific judgment.
Time frame: Up to 15 days after any vaccination
Percentage of Participants who Experience at Least 1 Serious Vaccine-Related AE
A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is another important medical event deemed such by medical or scientific judgment. An SAE that is considered by an investigator (a qualified physician) to be vaccine-related will be reported during entire study period.
Time frame: Up to Month 90
Showing the first 100 of 103 sites across 16 countries. Choose a country and city above to see the rest.
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · externaldatasharing-msd.com
Started Feb 2020 (actual). Primary completion is estimated for Jan 2027, 82 months after the start.
Of 54 industry-sponsored phase 3 interventional studies under Papillomavirus Infections, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 64. This study's planned 82 months is above that.
Counting every sponsor, half of 60 studies reached it within 29 months; a quarter within 16 and three quarters within 67.
Primary completion moved once since we started tracking on Sep 25, 2026: Aug 2027 → Jan 2027, on Oct 1, 2026.
Completion moved twice since we started tracking on Sep 25, 2026: Aug 2028 → Aug 2027, last on Oct 20, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Human Papillomavirus Recombinant Vaccine nonavalent