Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003399-10 | EudraCT Number | ||
| GDS07C | Other Identifier | MCMVaccBV (SPMSD) Protocol Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary objective
To demonstrate that administration of V503 induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to 26-year-old men
Secondary objectives
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V503 | Experimental | 9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6 |
|
| GARDASIL | Active Comparator | Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V503 | Biological | 9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18 | Serum antibodies to HPV types 6, 11, 16, and 18 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. | 4 weeks postdose 3 (Month 7) |
| Measure | Description | Time Frame |
|---|---|---|
| GMTs to HPV Types 31/33/45/52/58 | Serum antibodies to HPV types 31, 33, 45, 52, and 58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. | 4 weeks postdose 3 (Month 7) |
| Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi Pasteur MSD Investigational Site 1002 | Ghent | Belgium | ||||
| Sanofi Pasteur MSD Investigational Site 1003 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27354258 | Result | Van Damme P, Meijer CJLM, Kieninger D, Schuyleman A, Thomas S, Luxembourg A, Baudin M. A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men. Vaccine. 2016 Jul 29;34(35):4205-4212. doi: 10.1016/j.vaccine.2016.06.056. Epub 2016 Jun 25. | |
| 29211620 | Derived |
Not provided
Not provided
Not provided
A total of 502 participants were screened and 500 were randomized
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | V503 | 9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6 |
| FG001 | GARDASIL | Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | V503 | 9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6 |
| BG001 | GARDASIL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18 | Serum antibodies to HPV types 6, 11, 16, and 18 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. | All randomized participants. The number contributing to each data point is participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology for the HPV type within acceptable day ranges, were seronegative at Day 1, and had no protocol violations that interfered with evaluation of immune response. | Posted | Geometric Mean | 95% Confidence Interval | milli Merck U/mL | 4 weeks postdose 3 (Month 7) |
|
All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7
Not provided
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 | V503 | 9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytomegalovirus infection | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection-site erythema | General disorders | MedDRA version 17.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
Not provided
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| GARDASIL | Biological | Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection |
|
|
Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Type 33: ≥8; HPV Type 45: ≥8; HPV Type 52: ≥8; HPV Type 58: ≥8. |
| 4 weeks postdose 3 (Month 7) |
| Percentage of Participants With One or More Adverse Events | The percentage of participants with one or more adverse events was assessed. | Up to 15 days after any vaccination |
| Percentage of Participants With Study Discontinuation Due to an Adverse Event | The percentage of participants discontinued from the study due to an adverse event was assessed. | Up to Month 7 |
| Percentage of Participants With One or More Injection-site Adverse Reactions | The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed. | Up to 5 days after any vaccination |
| Percentage of Participants With Maximum Temperature ≥37.8 °C | The percentage of participants with a maximum temperature ≥37.8 °C was assessed. | Up to 5 days after any vaccination |
| Percentage of Participants With One or More Systemic Adverse Events | The percentage of participants with one or more systemic adverse events was assessed. | Up to 15 days after any vaccination |
| Percentage of Participants With One or More Serious Adverse Events | The percentage of participants with one or more serious adverse events was assessed. | Up to 15 days after any vaccination |
| Leuven |
| Belgium |
| Sanofi Pasteur MSD Investigational Site 1001 | Wilrijk | Belgium |
| Sanofi Pasteur MSD Investigational Site 3001 | Mainz | Germany |
| Sanofi Pasteur MSD Investigational Site 4001 | Amsterdam | Netherlands |
| Sanofi Pasteur MSD Investigational Site 4003 | Amsterdam | Netherlands |
| Sanofi Pasteur MSD Investigational Site 4002 | Nijmegen | Netherlands |
| Moreira ED, Giuliano AR, de Hoon J, Iversen OE, Joura EA, Restrepo J, Van Damme P, Vandermeulen C, Ellison MC, Krick A, Shields C, Heiles B, Luxembourg A. Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age. Hum Vaccin Immunother. 2018 Feb 1;14(2):396-403. doi: 10.1080/21645515.2017.1403700. Epub 2017 Dec 14. |
Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| GARDASIL |
Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6 |
|
|
|
| Secondary | GMTs to HPV Types 31/33/45/52/58 | Serum antibodies to HPV types 31, 33, 45, 52, and 58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. | All randomized participants. The number contributing to each data point is participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology for the HPV type within acceptable day ranges, were seronegative at Day 1, and had no protocol violations that interfered with evaluation of immune response | Posted | Geometric Mean | 95% Confidence Interval | milli Merck U/mL | 4 weeks postdose 3 (Month 7) |
|
|
|
| Secondary | Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58 | Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Type 33: ≥8; HPV Type 45: ≥8; HPV Type 52: ≥8; HPV Type 58: ≥8. | All randomized participants. The number contributing to each data point is participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology for the HPV type within acceptable day ranges, were seronegative at Day 1, and had no protocol violations that interfered with evaluation of immune response. | Posted | Number | 95% Confidence Interval | Percentage of participants | 4 weeks postdose 3 (Month 7) |
|
|
|
| Secondary | Percentage of Participants With One or More Adverse Events | The percentage of participants with one or more adverse events was assessed. | All participants who received at least one study vaccination and had safety follow-up data | Posted | Number | Percentage of participants | Up to 15 days after any vaccination |
|
|
|
| Secondary | Percentage of Participants With Study Discontinuation Due to an Adverse Event | The percentage of participants discontinued from the study due to an adverse event was assessed. | All participants who received at least one study vaccination and had safety follow-up data | Posted | Number | Percentage of participants | Up to Month 7 |
|
|
|
| Secondary | Percentage of Participants With One or More Injection-site Adverse Reactions | The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed. | All participants who received at least one study vaccination and had safety follow-up data | Posted | Number | Percentage of participants | Up to 5 days after any vaccination |
|
|
|
| Secondary | Percentage of Participants With Maximum Temperature ≥37.8 °C | The percentage of participants with a maximum temperature ≥37.8 °C was assessed. | All participants who received at least one study vaccination and had safety follow-up data | Posted | Number | Percentage of participants | Up to 5 days after any vaccination |
|
|
|
| Secondary | Percentage of Participants With One or More Systemic Adverse Events | The percentage of participants with one or more systemic adverse events was assessed. | All participants who received at least one study vaccination and had safety follow-up data | Posted | Number | Percentage of participants | Up to 15 days after any vaccination |
|
|
|
| Secondary | Percentage of Participants With One or More Serious Adverse Events | The percentage of participants with one or more serious adverse events was assessed. | All participants who received at least one study vaccination and had safety follow-up data | Posted | Number | Percentage of participants | Up to 15 days after any vaccination |
|
|
|
| 0 |
| 248 |
| 196 |
| 248 |
| EG001 | GARDASIL | Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6 | 6 | 248 | 189 | 248 |
| Concussion | Injury, poisoning and procedural complications | MedDRA version 17.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA version 17.1 | Systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA version 17.1 | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Systematic Assessment |
|
| Injection-site pain | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Injection-site swelling | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D053918 |
| Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
| HPV Type 33 |
|
|
| HPV Type 45 |
|
|
| HPV Type 52 |
|
|
| HPV Type 58 |
|
|
| HPV Type 11 |
|
|
| HPV Type 16 |
|
|
| HPV Type 18 |
|
|
| HPV Type 31 |
|
|
| HPV Type 33 |
|
|
| HPV Type 45 |
|
|
| HPV Type 52 |
|
|
| HPV Type 58 |
|
|