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| ID | Type | Description | Link |
|---|---|---|---|
| V503-064 | Other Identifier | MSD Protocol Number | |
| jRCT2031200217 | Registry Identifier | jRCT | |
| 2020-001047-67 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V503 | Experimental | In the base study, participants receive an intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6. |
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| Placebo | Placebo Comparator | In the base study, participants receive an IM injection of placebo at Day 1, Month 2, and Month 6. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V503 | Biological | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umeyama Clinic ( Site 6406) | Takasaki | Gunma | 370-0826 | Japan | ||
| Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 6424) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41276263 | Derived | 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. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | V503 | In the base study, participants received an intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6. |
| FG001 | Placebo | In the base study, participants received an IM injection of placebo at Day 1, Month 2, and Month 6. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Base Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2024 |
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| Placebo | Other | 0.9% sodium chloride (NaCL) |
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| 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. | 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. | Up to 5 days after any vaccination |
| 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). | 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). | 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). | 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). | 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). | 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). | Month 7 |
| Kawasaki |
| Kanagawa |
| 210-0852 |
| Japan |
| Ocean Clinic ( Site 6407) | Yokohama | Kanagawa | 231-8331 | Japan |
| Kanno Clinic ( Site 6402) | Sakai | Osaka | 590-0024 | Japan |
| P-One Clinic, Keikokai Medical Corp. ( Site 6419) | Hachiōji | Tokyo | 192-0071 | Japan |
| Iwasa Clinic ( Site 6411) | Osaka | 542-0073 | Japan |
| Nomura Clinic Namba ( Site 6405) | Osaka | 542-0076 | Japan |
| Medical Corporation Seiwakai Hayakawa Clinic ( Site 6409) | Osaka | 542-0086 | Japan |
| Yamanaka Clinic ( Site 6410) | Osaka | 553-0001 | Japan |
| Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6404) | Tokyo | 101-0041 | Japan |
| Yuge Clinic ( Site 6421) | Tokyo | 103-0014 | Japan |
| Taisei Clinic ( Site 6403) | Tokyo | 107-0052 | Japan |
| Mildix Skin Clinic ( Site 6423) | Tokyo | 120-0034 | Japan |
| Sugisawa Dermatology Clinic ( Site 6422) | Tokyo | 125-0041 | Japan |
| Medical Corporation Sanshikai Toru Clinic ( Site 6401) | Tokyo | 132-0011 | Japan |
| Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 6418) | Tokyo | 144-0051 | Japan |
| Seiyukai Medical Corporation Itoh Skin Clinic ( Site 6416) | Tokyo | 154-0024 | Japan |
| Naoko Dermatology Clinic ( Site 6417) | Tokyo | 158-0097 | Japan |
| Medical Corporation Iseikai My City Clinic ( Site 6414) | Tokyo | 160-0022 | Japan |
| Shinjuku Higashiguchi Clinic ( Site 6415) | Tokyo | 160-0022 | Japan |
| Ogikuboekimae Clinic ( Site 6413) | Tokyo | 167-0051 | Japan |
| Kusunoki Clinic ( Site 6412) | Tokyo | 175-0092 | Japan |
| FG002 | V503 → Open Label V503 Extension Study | Participants from V503 arm of the base study who did not complete the 3-dose series received 1 or 2 doses of V503, on Day 1, or Day 1 and Month 4 of the open label extension study. |
| FG003 | Placebo → Open Label V503 Extension Study | Participants from the placebo arm of the base study received 3 doses of V503 on Day 1, Month 2 and Month 6 of the open label extension study. |
| Vaccination 1: Day 1 |
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| Vaccination 2: Month 2 |
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| Vaccination 3: Month 6 |
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| COMPLETED |
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| NOT COMPLETED |
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| Extension Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | V503 | In the base study, participants received an intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6. |
| BG001 | Placebo | In the base study, participants received an IM injection of placebo at Day 1, Month 2, and Month 6. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Sexual Orientation Participant Subgroups | Participant randomization was stratified by sexual orientation heterosexual males (HM) or males who have sex with males (MSM). For HM, participants must be a heterosexual male, who has had exclusively female sexual partners, and has 1 to 5 lifetime female sexual partners at the time of enrollment. For MSM, participants must identify themselves as a male who has sex with males, must have engaged in either anal intercourse or oral sex with another male sexual partner within the last year, and have 0 to 5 lifetime male and/or female sexual partners at the time of enrollment. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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). | HPV type 6/11/16/18 eligible participants with data available in PPE population within acceptable day ranges; received all 3 vaccinations of correct dose within 1 year, Month 7 swab samples collected postdose 3 with PCR result, seronegative to the appropriate HPV type at baseline and PCR-negative to appropriate HPV type on all samples collected from baseline through Month 7, and no protocol deviations that could interfere with the evaluation of participant's immune response to V503. | Posted | Number | Cases per 100 Person-years | Up to approximately 36 Months |
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| Primary | 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. | All Participants as Treated (APaT) population, all randomized participants who received at least 1 dose of V503 or placebo and have provided safety data at any time during the study. | Posted | Number | Percentage of Participants | Up to 5 days after any vaccination |
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| Primary | 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. | All Participants as Treated (APaT) population, which consists of all randomized participants who received at least 1 dose of V503 or placebo and have provided safety data at any time during the study. | Posted | Number | Percentage of Participants | Up to 15 days after any vaccination |
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| Primary | 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. | All Participants as Treated (APaT) population, which consists of all randomized participants who received at least 1 dose of V503 or placebo and have provided safety data at any time during the study. | Posted | Number | Percentage of Participants | Up to approximately 37 months |
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| Primary | 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. | All Participants as Treated (APaT) population with temperature data available. APaT consists of all randomized participants who received at least 1 dose of V503 or placebo and have provided safety data at any time during the study. | Posted | Count of Participants | Participants | Up to 5 days after any vaccination |
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| Secondary | 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). | HPV type 31/33/45/52/58 eligible participants with data available in PPE population within acceptable day ranges; received all 3 vaccinations of correct dose within 1 year, Month 7 swab samples collected postdose 3 with PCR result, seronegative to appropriate HPV type at baseline and PCR-negative to appropriate HPV type on all samples collected from baseline through Month 7, and no protocol deviations that could interfere with the evaluation of participant's immune response to V503. | Posted | Number | cases per 100 Person-years | Up to approximately 36 Months |
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| Secondary | 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). | Eligible all randomized participants PPI population; within acceptable day ranges; received 3 vaccinations of correct dose within 1 year, Month 7 swab samples collected postdose 3 with PCR result, seronegative to appropriate HPV type(s) at baseline and PCR-negative to appropriate HPV type(s) on samples collected from baseline through Month 7, provided serological samples, and had no protocol deviations that could interfere with the evaluation of participant's immune response to V503. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Month 7 |
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| Secondary | 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). | HM subgroup of the PPI population; within the acceptable day ranges, received 3 vaccinations of correct dose within 1 year, Month 7 swab samples collected postdose 3 with PCR result, seronegative to appropriate HPV type(s) at baseline and PCR-negative to appropriate HPV type(s) on all samples collected from baseline through Month 7, provided serological samples, and had no protocol deviations that could interfere with the evaluation of participant's immune response to V503. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Month 7 |
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| Secondary | 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). | MSM subgroup of the PPI population; within the acceptable day ranges, received 3 vaccinations of correct dose within 1 year, Month 7 swab samples collected postdose 3 with PCR result, seronegative to appropriate HPV type(s) at baseline and PCR-negative to appropriate HPV type(s) on all samples collected from baseline through Month 7, provided serological samples, and had no protocol deviations that could interfere with the evaluation of participant's immune response to V503. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Month 7 |
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| Secondary | 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). | Eligible all randomized participants PPI population; within acceptable day ranges; received 3 vaccinations of correct dose within 1 year, Month 7 swab samples collected postdose 3 with PCR result, seronegative to appropriate HPV type(s) at baseline and PCR-negative to appropriate HPV type(s) on samples collected from baseline through Month 7, provided serological samples, and had no protocol deviations that could interfere with the evaluation of participant's immune response to V503. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 7 |
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| Secondary | 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). | HM subgroup of the PPI population; within the acceptable day ranges, received 3 vaccinations of correct dose within 1 year, Month 7 swab samples collected postdose 3 with PCR result, seronegative to appropriate HPV type(s) at baseline and PCR-negative to appropriate HPV type(s) on all samples collected from baseline through Month 7, provided serological samples, and had no protocol deviations that could interfere with the evaluation of participant's immune response to V503. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 7 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | MSM subgroup of the PPI population; within the acceptable day ranges, received 3 vaccinations of correct dose within 1 year, Month 7 swab samples collected postdose 3 with PCR result, seronegative to appropriate HPV type(s) at baseline and PCR-negative to appropriate HPV type(s) on all samples collected from baseline through Month 7, provided serological samples, and had no protocol deviations that could interfere with the evaluation of participant's immune response to V503. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 7 |
|
Up to approximately 55 months
All-cause mortality included all the randomized participants. Non-serious and serious adverse events were reported on all participants as treated (APaT). Per protocol, the APaT population consists of all randomized participants who received at least 1 dose of V503 or placebo and have provided safety data at any time during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Base Study: V503 | Participants received an IM injection of V503 at Day 1, Month 2, and Month 6. | 0 | 529 | 7 | 529 | 374 | 529 |
| EG001 | Base Study: Placebo | Participants received an IM injection of placebo at Day 1, Month 2, and Month 6. | 0 | 530 | 5 | 530 | 183 | 530 |
| EG002 | Base Study: V503 → Open Label V503 Extension Study | Participants from V503 arm of the base study who did not complete the 3-dose series received 1 or 2 doses of V503, on Day 1, or Day 1 and Month 4 of the open label extension study. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | Base Study: Placebo → Open Label V503 Extension Study | Participants from the placebo arm of the base study received 3 doses of V503 on Day 1, Month 2 and Month 6 of the open label extension study. | 0 | 381 | 2 | 381 | 0 | 381 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Chronic tonsillitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Dec 12, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| Withdrawal by Subject |
|
| Physician Decision |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Males Who Have Sex With Males (MSM) |
|
| Counts |
|---|
| Participants |
|
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|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Units | Counts |
|---|---|
| Participants |
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| OG001 | Placebo | In the base study, participants received an IM injection of placebo at Day 1, Month 2, and Month 6. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 | Placebo | In the base study, participants received an IM injection of placebo at Day 1, Month 2, and Month 6. |
|
|
| OG001 | Placebo | In the base study, participants received an IM injection of placebo at Day 1, Month 2, and Month 6. |
|
|
| OG001 | Placebo | In the base study, participants received an IM injection of placebo at Day 1, Month 2, and Month 6. |
|
|