Papillomavirus InfectionsPhase 3NCT03998254
Efficacy, Immunogenicity and Safety of V503 in Chinese Women Aged 20-45 Years (V503-023)
A Phase 3 study testing V503 and Gardasil in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC at 6 sites in China.
Trial summary
This study will evaluate the efficacy, immunogenicity and safety of 9-valent human papillomavirus (9vHPV; V503) vaccine in Chinese women 20 to 45 years of age. The primary hypotheses are: 9vHPV vaccine reduces the incidence of HPV 31-, 33-, 45-, 52-, and 58-related 12-month persistent infection at least 1 month post… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Infections
- What is being tested?
- V503 and Gardasil
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 6 sitesChina
- Study dates
- 26 Jun 2019to 30 Nov 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Has not had sex with males or has had sex with males and used effective contraception with no failures since the first day of the participant's last menstrual period through Day 1
- Agrees to use effective contraception if has sex with a male partner during study
- Has had sexual intercourse with male partners, and has had 1 to 4 male and/or female sexual partners
Who cannot join
- History of a positive test for HPV
- History of an abnormal Pap test result showing ASC-US, atypical squamous cells - cannot exclude HSIL (high grade squamous intraepithelial lesion [(ASC-H)], low-grade squamous intraepithelial lesion (LSIL), HSIL), or atypical glandular cells
- History of an abnormal cervical biopsy result showing CIN, adenocarcinoma in situ or cervical cancer
- History of or clinical evidence at the Day 1 gynecologic examination of HPV-related anogenital diseases (e.g., genital warts, VIN, VaIN, AIN, vulvular cancer, vaginal cancer or anal cancer
- Does not have an intact cervix uteri or has more than one cervix uteri
- Is pregnant
Show all 17Show fewer
- Known allergy to any vaccine component, including aluminum, yeast, or Benzonase™ (nuclease, Nycomed™ [used to remove residual nucleic acids from this and other vaccines])
- History of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention
- Has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
- Currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition
- Has had a splenectomy
- Is expecting to donate eggs during Day 1 through Month 7 of the study
- Plans to receive during Day 1 through Month 7 of the study, is receiving or has received within 12 months prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), tumor necrosis factor (TNF)-α antagonists, monocolonal antibody therapies (including rituximab [Rituxan™]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a participant will be excluded if she is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of high dose corticosteroids (orally or parenterally) lasting at least 1 week within 12 months prior to enrollment. Participants using inhaled, nasal, or topical corticosteroids are considered eligible for the study.
- Plans to receive during Day 1 through Month 7 of the study, is receiving or has received within the 6 months prior to the Day 1 vaccination any immune globulin product (including RhoGAM™) or blood derived product other than IVIG
- Has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical study and has received either active agent or placebo
- Concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical specimens
- User of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence at the discretion of the investigator. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Xiangyuan Center for Disease Control and Prevention ( Site 0003)
Changzhi, Shanxi, 046299
Lingchuan Center for Disease Control and Prevention ( Site 0002)
Guilin, Guangxi, 541200
Quanzhou Center for Disease Control and Prevention ( Site 0001)
Guilin, Guangxi, 541500
Mianyang Center for Disease Control and Prevention ( Site 0005)
Mianyang, Sichuan, 621000
Santai County Center for Disease Control and Prevention ( Site 0006)
Mianyang, Sichuan, 621100
Yanhu Center for Disease Control and Prevention of Yuncheng ( Site 0004)
Yuncheng, Shanxi, 044000
About this study
Official title: A Phase 3 Randomized, Double-Blinded, Controlled With GARDASIL® Efficacy, Immunogenicity and Safety Study of V503 [a 9-Valent HPV Vaccine] in Chinese Women 20 to 45 Years of Age
This study will evaluate the efficacy, immunogenicity and safety of 9-valent human papillomavirus (9vHPV; V503) vaccine in Chinese women 20 to 45 years of age. The primary hypotheses are: 9vHPV vaccine reduces the incidence of HPV 31-, 33-, 45-, 52-, and 58-related 12-month persistent infection at least 1 month post Dose 3, compared with quadrivalent HPV (qHPV) vaccine in women 20 to 45 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR) negative Day 1 through Month 7 to the relevant HPV type; and 9vHPV vaccine induces non-inferior competitive luminex immunoassay (cLIA) geometric mean titers (GMTs) for each of HPV 6, 11, 16, and 18 one month post Dose 3, compared with qHPV vaccine in women 20 to 45 years of age who are seronegative at Day 1 and PCR negative Day 1 through Month 7 to the relevant HPV type.
Read the detailed description
This study has two stages with the Stage I expected from Day 1 through Month 30, and the Stage II expected post-Month 30 to Month 90. The Stage I study is a case-driven study which aims to accrue at least 20 cases of HPV 31/33/45/52/58-related 12-month persistent infection and at least 39 cases of HPV 31/33/45/52/58-related 6-month persistent infection by completion of Month 30 visit. The Stage II study is a case-driven study which aims to accrue at least 12 cases of HPV 31/33/45/52/58-related cervical intraepithelial neoplasia grade 2 or 3 (CIN 2/3), cervical adenocarcinoma in situ (AIS), and cervical cancer observed in both Stage I and Stage II, by completion of Month 90 visit.
After completion of Stage II, participants in the qHPV vaccine group will be offered a 3-dose regimen of V503 in the Extension Stage. Participants in the V503 group who did not complete the 3-dose regimen in Stage I will also be eligible to receive any remaining V503 doses to complete the regimen.
- Conditions
- Papillomavirus Infections
- Being tested
- V503, Gardasil
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V503Drug
9vHPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine
GardasilDrug
qHPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine
| Study group | Role | What they receive |
|---|---|---|
| V503 | Experimental | Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6 Receives: Drug: V503 |
| Gardasil | Active comparator | Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6 Receives: Drug: Gardasil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage I: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related 12-month Persistent Infection
A 12-month persistent infection This endpoint is defined to have occurred if a participant who is positive for the same HPV type by the HPV PCR assay in the LVPP/EEC swabs, biopsy, ECC or definitive therapy samples obtained in 3 or more consecutive visits over a period of at least 12 months. Incidence is defined as the number of cases of persistent infection per 10,000 person-years of follow-up in a treatment arm.
Measured: 1 month post vaccination 3 (Month 7) up to Month 30
Stage I: Geometric Mean Titers to HPV Types 6, 11, 16, and 18 Antibodies
Serum antibodies to HPV types 6/11/16/18 are measured with a Competitive Luminex Immunoassay (cLIA). Titers are reported in milli Merck Units/mL.
Measured: 1-month post vaccination 3 (Month 7)
Stage I: Percentage of Participants Who Report at Least 1 Solicited Injection-site Adverse Event
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with 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. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site are recorded.
Measured: up to 8 days post any vaccination
Stage I: Percentage of Participants Who Report at Least 1 Solicited Systemic Adverse Event
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with 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.
Measured: up to 30 days post any vaccination
Stage I: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with 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. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
Measured: Day 1 up to approximately Month 30
Stage II: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related CIN 2/3, AIS, and cervical cancer
This endpoint is defined to have occurred if on a single cervical biopsy, ECC, LEEP or Conization (cold knife/laser) specimen, there is: (a) a HPV Pathology Panel consensus diagnosis of CIN (grade 2 or 3), AIS, or cervical cancer; AND (b) detection of at least 1 of HPV types 31, 33, 45, 52 or 58 by Thinsection PCR in an adjacent section from the same tissue block. Disease incidence is defined as the number cases per 10,000 person-years of follow-up in a treatment arm.
Measured: Month 7 up to Month 90
Stages I/II: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with 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. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
Measured: Day 1 up to approximately Month 90
Secondary outcomes (13)
Stage I: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month Persistent Infection
A 6-month persistent infection is defined to have occurred if a participant who is positive for the same HPV type by the HPV PCR assay in the LVPP/EEC swabs, biopsy, ECC or definitive therapy obtained in 2 or more consecutive visits over a period of at least 6 months. Incidence is defined as the number of cases of persistent infection per 10,000 person-years of follow-up in a treatment arm.
Measured: 1 month post vaccination 3 (Month 7) up to Month 30
Stage I: Percentage of Participants Who Seroconvert by cLIA to HPV Types 6, 11, 16, and 18
Serum antibody titers for HPV types 6, 11, 16, and 18 will be determined using cLIA. The percentage of participants that achieve the serostatus cut-offs for seroconversion for each HPV type will be summarized.
Measured: 1 Month Post Vaccination 3 (Month 7)
Stage I: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related 12-month Persistent Cervical Infection
A 12-month persistent cervical infection is defined to have occurred if a participant who is positive for the same HPV type by the HPV PCR assay in the EEC swabs, cervical biopsy, ECC or cervical definitive therapy samples obtained in 3 or more consecutive visits over a period of at least 12 months. Incidence is defined as the number of cases of persistent infection per 10,000 person-years of follow-up in a treatment arm.
Measured: 1 month post vaccination 3 (Month 7) up to Month 30
Stage I: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related 12-month Persistent Non-cervical Infection
A 12-month persistent non-cervical infection is defined to have occurred if a participant who is positive for the same HPV type by the HPV PCR assay in the LVPP swabs, biopsy, or definitive therapy samples obtained from the external genitalia in 3 or more consecutive visits over a period of at least 12 months. Incidence is defined as the number of cases of persistent infection per 10,000 person-years of follow-up in a treatment arm.
Measured: 1 month post vaccination 3 (Month 7) up to Month 30
Stage I: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month Persistent Cervical Infection
A 6-month persistent cervical infection is defined to have occurred if a participant who is positive for the same HPV type by the HPV PCR assay in the EEC swabs, cervical biopsy, ECC or cervical definitive therapy samples obtained in 2 or more consecutive visits over a period of at least 6 months. . Incidence is defined as the number of cases of persistent infection per 10,000 person-years of follow-up in a treatment arm.
Measured: 1 month post vaccination 3 (Month 7) up to Month 30
Stage I: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month Persistent Non-cervical Infection
A 6-month persistent non-cervical infection is defined to have occurred if a participant who is positive for the same HPV type by the HPV PCR assay in the LVPP swabs, biopsy, or definitive therapy samples obtained from the external genitalia in 2 or more consecutive visits over a period of at least 6 months. . Incidence is defined as the number of cases of persistent infection per 10,000 person-years of follow-up in a treatment arm.
Measured: 1 month post vaccination 3 (Month 7) up to Month 30
Stage I: Combined Incidence of Papanicolaou (Pap) Test Abnormalities That are Related to HPV 31, 33, 45, 52, or 58
This endpoint is defined to have occurred if a participant is found to have: (a) a Pap test result of ASC-US positive for high risk HPV, LSIL, ASC-H, HSIL, atypical glandular cells, or adenocarcinoma in situ, etc.; AND (b) detection of at least 1 of HPV types 31, 33, 45, 52 or 58 by LVPP or EEC swab at the same study visit. Incidence is defined as the number of cases of persistent infection per 10,000 person-years of follow-up in a treatment arm.
Measured: Month 7 up to Month 30
Stage I: Geometric Mean Titers of HPV 31, 33, 45, 52 , and 58 Antibodies
Serum antibodies to HPV types 31/33/45/52 /58 are measured with cLIA. Titers are reported in milli Merck Units/mL.
Measured: 1 Month Post Vaccination 3 (Month 7)
Stage I: Percentage of Participants Who Seroconvert by cLIA to HPV Types 31, 33, 45, 52 , and 58
Serum antibody titers for HPV types 31/33/45/52 /58 will be determined using cLIA. The percentage of participants that achieve the serostatus cut-offs for seroconversion for each HPV type will be summarized.
Measured: 1 Month Post Vaccination 3 (Month 7)
Stage II: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related CIN 1/2/3, AIS, and cervical cancer
This endpoint is defined to have occurred if on a single cervical biopsy, ECC, LEEP or Conization (cold knife/laser) specimen, there is: (a) a pathology panel consensus diagnosis of CIN (Grade 1, 2 or 3), AIS, or cervical cancer; AND (b) detection of at least 1 of HPV types 31, 33, 45, 52 or 58 by Thinsection PCR in an adjacent section from the same tissue block. Disease incidence is defined as the number cases per 10,000 person-years of follow-up in a treatment arm.
Measured: Month 7 to Month 90
Stage II: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related genital warts, CIN 2/3, AIS, cervical cancer, VIN 2/3, VaIN 2/3, vulvar cancer, and vaginal cancer
This endpoint is defined to have occurred if on a single biopsy or excised tissue, there is: (a) a Pathology Panel consensus diagnosis of CIN (grade 2 or 3), AIS, cervical cancer, VIN (grade 2 or 3), VaIN (grade 2 or 3), vulvar cancer, or vaginal cancer; AND (b) detection of at least 1 of HPV types 31, 33, 45, 52 or 58 by Thinsection PCR in an adjacent section from the same tissue block. Incidence is defined as the number of cases of persistent infection per 10,000 person-years of follow-up in a treatment arm.
Measured: Month 7 up to Month 90
Stage II: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related genital warts, CIN 1/2/3, AIS, cervical cancer, VIN 1/2/3, VaIN 1/2/3, vulvar cancer, and vaginal cancer
This endpoint is defined to have occurred if on a single biopsy or excised tissue, there is: (a) a Pathology Panel consensus diagnosis of CIN (grade 1, 2 or 3), AIS, cervical cancer, VIN (grade 1, 2 or 3), VaIN (grade 1, 2 or 3), vulvar cancer, or vaginal cancer; AND (b) detection of at least 1 of HPV types 31, 33, 45, 52 or 58 by Thinsection PCR in an adjacent section from the same tissue block. Disease incidence is defined as the number cases per 10,000 person-years of follow-up in a treatment arm.
Measured: Month 7 to Month 90
Stage II: Combined Incidence of HPV 31-, 33-, 45-, 52- , or 58-related Cervical, Vaginal and External Genital Biopsy and Definitive Therapy
This endpoint is defined to have occurred if a participant is found to have: (a) a cervical, vaginal or external genital biopsy or definitive therapy; AND (b) a tissue sample from such procedure was detected as PCR positive for at least 1 of HPV types 31, 33, 45, 52 or 58, regardless of the pathology diagnosis of such tissue sample. Incidence of biopsy and definitive therapy will be summarized as the number of cases per 10,000 person-years of follow-up in a treatment arm.
Measured: Month 7 up to Month 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start26 Jun 2019
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6,000 participants (estimated)
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
- NCT03998254
- Sponsor's protocol ID
- V503-023
- Other IDs
- V503-023
- Status last verified
- Aug 2026
- First submitted
- 21 Jun 2019
- Last updated
- 1 Sep 2026
- Results posted
- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-Blinded, Controlled With GARDASIL® Efficacy, Immunogenicity and Safety Study of V503 [a 9-Valent HPV Vaccine] in Chinese Women 20 to 45 Years of Age
- ClinicalTrials.gov ID
- NCT03998254
- Acronym / sponsor ID
- V503-023
- Conditions
- Papillomavirus Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy, immunogenicity and safety of 9-valent human papillomavirus (9vHPV; V503) vaccine in Chinese women 20 to 45 years of age. The primary hypotheses are: 9vHPV vaccine reduces the incidence of HPV 31-, 33-, 45-, 52-, and 58-related 12-month persistent infection at least 1 month post Dose 3, compared with quadrivalent HPV (qHPV) vaccine in women 20 to 45 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR) negative Day 1 through Month 7 to the relevant HPV type; and 9vHPV vaccine induces non-inferior competitive luminex immunoassay (cLIA) geometric mean titers (GMTs) for each of HPV 6, 11, 16, and 18 one month post Dose 3, compared with qHPV vaccine in women 20 to 45 years of age who are seronegative at Day 1 and PCR negative Day 1 through Month 7 to the relevant HPV type.
Detailed description
This study has two stages with the Stage I expected from Day 1 through Month 30, and the Stage II expected post-Month 30 to Month 90. The Stage I study is a case-driven study which aims to accrue at least 20 cases of HPV 31/33/45/52/58-related 12-month persistent infection and at least 39 cases of HPV 31/33/45/52/58-related 6-month persistent infection by completion of Month 30 visit. The Stage II study is a case-driven study which aims to accrue at least 12 cases of HPV 31/33/45/52/58-related cervical intraepithelial neoplasia grade 2 or 3 (CIN 2/3), cervical adenocarcinoma in situ (AIS), and cervical cancer observed in both Stage I and Stage II, by completion of Month 90 visit.
After completion of Stage II, participants in the qHPV vaccine group will be offered a 3-dose regimen of V503 in the Extension Stage. Participants in the V503 group who did not complete the 3-dose regimen in Stage I will also be eligible to receive any remaining V503 doses to complete the regimen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V503 | Experimental | Drug: V503Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6 |
| Gardasil | Active comparator | Drug: GardasilSingle 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Has not had sex with males or has had sex with males and used effective contraception with no failures since the first day of the participant's last menstrual period through Day 1
- Agrees to use effective contraception if has sex with a male partner during study
- Has had sexual intercourse with male partners, and has had 1 to 4 male and/or female sexual partners
Key exclusion criteria (17 listed)
- History of a positive test for HPV
- History of an abnormal Pap test result showing ASC-US, atypical squamous cells - cannot exclude HSIL (high grade squamous intraepithelial lesion [(ASC-H)], low-grade squamous intraepithelial lesion (LSIL), HSIL), or atypical glandular cells
- History of an abnormal cervical biopsy result showing CIN, adenocarcinoma in situ or cervical cancer
- History of or clinical evidence at the Day 1 gynecologic examination of HPV-related anogenital diseases (e.g., genital warts, VIN, VaIN, AIN, vulvular cancer, vaginal cancer or anal cancer
- Does not have an intact cervix uteri or has more than one cervix uteri
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 |
|---|---|---|
| V5039vHPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine | Drug | V503 |
| GardasilqHPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine | Drug | Gardasil |
Primary outcome
Stage I: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related 12-month Persistent Infection
Time frame: 1 month post vaccination 3 (Month 7) up to Month 30
A 12-month persistent infection This endpoint is defined to have occurred if a participant who is positive for the same HPV type by the HPV PCR assay in the LVPP/EEC swabs, biopsy, ECC or definitive therapy samples obtained in 3 or more consecutive visits over a period of at least 12 months. Incidence is defined as the number of cases of persistent infection per 10,000 person-years of follow-up in a treatment arm.
Stage I: Geometric Mean Titers to HPV Types 6, 11, 16, and 18 Antibodies
Time frame: 1-month post vaccination 3 (Month 7)
Serum antibodies to HPV types 6/11/16/18 are measured with a Competitive Luminex Immunoassay (cLIA). Titers are reported in milli Merck Units/mL.
Stage I: Percentage of Participants Who Report at Least 1 Solicited Injection-site Adverse Event
Time frame: up to 8 days post any vaccination
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with 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. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site are recorded.
Stage I: Percentage of Participants Who Report at Least 1 Solicited Systemic Adverse Event
Time frame: up to 30 days post any vaccination
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with 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.
Stage I: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
Time frame: Day 1 up to approximately Month 30
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with 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. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
Stage II: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related CIN 2/3, AIS, and cervical cancer
Time frame: Month 7 up to Month 90
This endpoint is defined to have occurred if on a single cervical biopsy, ECC, LEEP or Conization (cold knife/laser) specimen, there is: (a) a HPV Pathology Panel consensus diagnosis of CIN (grade 2 or 3), AIS, or cervical cancer; AND (b) detection of at least 1 of HPV types 31, 33, 45, 52 or 58 by Thinsection PCR in an adjacent section from the same tissue block. Disease incidence is defined as the number cases per 10,000 person-years of follow-up in a treatment arm.
Stages I/II: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
Time frame: Day 1 up to approximately Month 90
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with 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. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
13 secondary outcomes
Stage I: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month Persistent Infection
Time frame: 1 month post vaccination 3 (Month 7) up to Month 30
Stage I: Percentage of Participants Who Seroconvert by cLIA to HPV Types 6, 11, 16, and 18
Time frame: 1 Month Post Vaccination 3 (Month 7)
Stage I: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related 12-month Persistent Cervical Infection
Time frame: 1 month post vaccination 3 (Month 7) up to Month 30
Stage I: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related 12-month Persistent Non-cervical Infection
Time frame: 1 month post vaccination 3 (Month 7) up to Month 30
Stage I: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month Persistent Cervical Infection
Time frame: 1 month post vaccination 3 (Month 7) up to Month 30
Stage I: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month Persistent Non-cervical Infection
Time frame: 1 month post vaccination 3 (Month 7) up to Month 30
Stage I: Combined Incidence of Papanicolaou (Pap) Test Abnormalities That are Related to HPV 31, 33, 45, 52, or 58
Time frame: Month 7 up to Month 30
Stage I: Geometric Mean Titers of HPV 31, 33, 45, 52 , and 58 Antibodies
Time frame: 1 Month Post Vaccination 3 (Month 7)
Stage I: Percentage of Participants Who Seroconvert by cLIA to HPV Types 31, 33, 45, 52 , and 58
Time frame: 1 Month Post Vaccination 3 (Month 7)
Stage II: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related CIN 1/2/3, AIS, and cervical cancer
Time frame: Month 7 to Month 90
Stage II: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related genital warts, CIN 2/3, AIS, cervical cancer, VIN 2/3, VaIN 2/3, vulvar cancer, and vaginal cancer
Time frame: Month 7 up to Month 90
Stage II: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related genital warts, CIN 1/2/3, AIS, cervical cancer, VIN 1/2/3, VaIN 1/2/3, vulvar cancer, and vaginal cancer
Time frame: Month 7 to Month 90
Stage II: Combined Incidence of HPV 31-, 33-, 45-, 52- , or 58-related Cervical, Vaginal and External Genital Biopsy and Definitive Therapy
Time frame: Month 7 up to Month 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- 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.
- 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
6 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 and Gardasil in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC at 6 sites in China.
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 17 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: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Stage I: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related 12-month Persistent Infection (time frame: 1 month post vaccination 3 (Month 7) up to Month 30). The study lists 7 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 NCT03998254, 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 1 Sep 2026.