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| ID | Type | Description | Link |
|---|---|---|---|
| GDS01C | Other Identifier | MCMVaccBV (SPMSD) Protocol Number | |
| 2010-023393-39 | EudraCT Number |
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Primary objective:
• To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL.
Secondary objectives:
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| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) to HPV Types 16 and 18 | Serum antibodies to HPV types 16 and 18 were measured with a Competitive Luminex Immunoassay. | 4 weeks postdose 3 (Month 7) |
| Measure | Description | Time Frame |
|---|---|---|
| GMTs to HPV Types 6 and 11 | Serum antibodies to HPV types 6 and 11 were measured with a Competitive Luminex Immunoassay. | 4 weeks postdose 3 (Month 7) |
| Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26090572 | Result | Vesikari T, Brodszki N, van Damme P, Diez-Domingo J, Icardi G, Petersen LK, Tran C, Thomas S, Luxembourg A, Baudin M. A Randomized, Double-Blind, Phase III Study of the Immunogenicity and Safety of a 9-Valent Human Papillomavirus L1 Virus-Like Particle Vaccine (V503) Versus Gardasil(R) in 9-15-Year-Old Girls. Pediatr Infect Dis J. 2015 Sep;34(9):992-8. doi: 10.1097/INF.0000000000000773. | |
| 27422279 |
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A total of 603 participants were screened and 600 were randomized
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| 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
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| 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 16 and 18 | Serum antibodies to HPV types 16 and 18 were measured with a Competitive Luminex Immunoassay. | All randomized participants. The n values are participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology to the HPV type within acceptable day ranges, were seronegative to the HPV type at Day 1, and had no protocol violations that interfered with evaluation of immune response. | Posted | Geometric Mean | 95% Confidence Interval | milli Merck Units/mL | 4 weeks postdose 3 (Month 7) |
|
All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7
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| 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 |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| 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 |
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| GARDASIL | Biological | Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine |
|
|
Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck Units/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24. The percentage of participants who were seropositive according to these cutoffs was assessed.
| 4 weeks postdose 3 (Month 7) |
| Percentage of Participants With One or More Adverse Events | An adverse event is defined as any unfavourable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event. The percentage of participants with one or more adverse events 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 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 Maximum Oral Temperature ≥37.8°C | The percentage of participants with maximum oral temperature ≥37.8°C was assessed. | Up to 15 days after any vaccination |
| Percentage of Participants With One or More Serious Adverse Events | A serious adverse event is an adverse event that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse events was assessed. | Up to Month 7 |
| Derived |
| Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15. |
| Protocol Violation |
|
| Lost to Follow-up |
|
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 |
|
| 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 6 and 11 | Serum antibodies to HPV types 6 and 11 were measured with a Competitive Luminex Immunoassay. | All randomized participants. The n values are participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology to the HPV type within acceptable day ranges, were seronegative to the HPV type at Day 1, and had no protocol violations that interfered with evaluation of immune response. | Posted | Geometric Mean | 95% Confidence Interval | milli Merck Units/mL | 4 weeks postdose 3 (Month 7) |
|
|
|
| Secondary | Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18 | Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck Units/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24. The percentage of participants who were seropositive according to these cutoffs was assessed. | All randomized participants. The n values are participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology to the HPV type within acceptable day ranges, were seronegative to the HPV type 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 | An adverse event is defined as any unfavourable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event. 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 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 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 Maximum Oral Temperature ≥37.8°C | The percentage of participants with maximum oral 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 15 days after any vaccination |
|
|
|
| Secondary | Percentage of Participants With One or More Serious Adverse Events | A serious adverse event is an adverse event that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. 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 Month 7 |
|
|
|
| 1 |
| 299 |
| 280 |
| 299 |
| 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 | 2 | 300 | 274 | 300 |
| Complex partial seizures | Nervous system disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Pulmonary vasculitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.1 | Systematic Assessment |
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| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Injection-site erythema | General disorders | MedDRA version 14.1 | Systematic Assessment |
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| Injection-site pain | General disorders | MedDRA version 14.1 | Systematic Assessment |
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| Injection-site swelling | General disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 14.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 14.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.1 | 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.
| D053918 |
| Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
| HPV Type 16 (n=276, 270) |
|
| HPV Type 18 (n=276, 269) |
|