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
Not provided
Not provided
This is a study of V501 [quadrivalent Human Papillomavirus (HPV) (Type 6, 11, 16 and 18) L1 virus-like particle (VLP) vaccine] in healthy Japanese boys. This study will consist of two periods. Period I of the study is to evaluate the immunogenicity and tolerability of V501 up to Month 7. Period II of the study is to evaluate the long-term immunogenicity and safety from Month 7 to Month 30. Two analyses are planned. The first analysis will be conducted when all subjects have completed their Month 7 visit or have been discontinued before that time. The second analysis will be conducted at the end of study. The primary hypothesis tested in this study is that seroconversion rates for the vaccine HPV types will be >90% at 4 weeks postdose 3.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V501 | Experimental | 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V501 | Biological | Quadrivalent HPV [Type 6, 11, 16 and 18] L1 VLP vaccine), 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18 | Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay 4 weeks after 3rd vaccination (Month 7). Antibody titers were expressed as milli Merck units/mL (mMU/mL). Seroconversion was defined as an anti-HPV 6 titer ≥20 mMU/mL, an anti-HPV 11 titer ≥16 mMU/mL, an anti-HPV 16 titer of ≥20 mMU/mL and an anti-HPV 18 titer of ≥24 mMU/mL. | Four weeks postdose 3 (Month 7) |
| Percentage of Participants With Elevated Oral Temperature (>=37.5° C) | The parent/guardian of the participant was to record the participant's oral temperature in the evening after each study vaccination and daily for 4 days after each study vaccination. Elevated temperature was defined as ≥99.5°F (≥37.5ºC). The percentage of participants that had an elevated temperature was summarized. | Up to Day 5 after any vaccination |
| Percentage of Participants With an Injection-site Adverse Event | An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The parent/guardian of the participant was to record 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 (erythema, pain, and swelling) was summarized. | Up to Day 5 after any vaccination |
| Percentage of Participants With a Systemic Adverse Event | An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The parent/guardian of the participant was to record the presence of any VRC-prompted systemic AEs that occurred in the 5 days after any vaccination. The percentage of participants with a systemic AE was summarized. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18 Participants Aged 9 to 15 Years Versus Participants Aged 16 to 26 Years | Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed mMU/mL. GMTs obtained for each anti-HPV from this study were compared to each of the ant-HPV GMTs obtained in study V501-122 (NCT NCT01862874) in which Japanese males 16 to 26 years received V501 in the same 3 dose regimen, to test a hypothesis that would demonstrate non-inferiority. |
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 |
|---|---|---|---|---|---|---|
| MSD K.K. | Chiyoda-Ku, Tokyo | 102-8667 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31155600 | Result | Murata S, Takeuchi Y, Yamanaka K, Hayakawa J, Yoshida M, Yokokawa R, Wakana A, Sawata M, Tanaka Y. Safety and Immunogenicity of the Quadrivalent HPV Vaccine in Japanese Boys: a Phase 3, Open-Label Study. Jpn J Infect Dis. 2019 Sep 19;72(5):299-305. doi: 10.7883/yoken.JJID.2018.448. Epub 2019 May 31. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | V501 | 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | V501 | 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6 |
| 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 | Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18 | Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay 4 weeks after 3rd vaccination (Month 7). Antibody titers were expressed as milli Merck units/mL (mMU/mL). Seroconversion was defined as an anti-HPV 6 titer ≥20 mMU/mL, an anti-HPV 11 titer ≥16 mMU/mL, an anti-HPV 16 titer of ≥20 mMU/mL and an anti-HPV 18 titer of ≥24 mMU/mL. | All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 7 serology result within 21 to 49 days post dose 3. | Posted | Mean | 95% Confidence Interval | Percentage of Participants | Four weeks postdose 3 (Month 7) |
|
Up to 30 months
Population included all participants that received at least 1 vaccination
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 | V501 | 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6 | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 21.0 | 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
| 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 | Aug 21, 2015 | Jul 24, 2019 | Prot_SAP_000.pdf |
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
Not provided
| Up to Day 15 after any vaccination |
| Percentage of Participants With a Serious Adverse Event | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (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, is a cancer, is an overdose, or is another important medical event. The percentage of participants that experienced 1 or more SAEs was summarized. | Up to Day 15 after any vaccination |
| Percentage of Participants With a Vaccine-related Serious Adverse Event | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (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, is a cancer, is an overdose, or is another important medical event. The percentage of participants that experienced 1 or more SAEs that were considered at least possibly related to the study vaccine was summarized. | Up to 30 months |
| Four weeks postdose 3 (Month 7) |
| Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 18 Months | Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed as mMU/mL. | 12 months postdose 3 (18 months) |
| Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 30 Months | Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed as mMU/mL. | 24 months postdose 3 (30 months) |
| Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 18 Months | Serum antibodies to HPV types were measured with a competitive luminex immunoassay. The serostatus cutoffs (mMU/mL) for HPV types were as follows: HPV Type 6: ≥20; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24 | 12 months postdose 3 (18 months) |
| Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 30 Months | Serum antibodies to HPV types were measured with a competitive luminex immunoassay. The serostatus cutoffs (mMU/mL) for HPV types were as follows: HPV Type 6: ≥20; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24. | 24 months postdose 3 (30 months) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Participants With Elevated Oral Temperature (>=37.5° C) | The parent/guardian of the participant was to record the participant's oral temperature in the evening after each study vaccination and daily for 4 days after each study vaccination. Elevated temperature was defined as ≥99.5°F (≥37.5ºC). The percentage of participants that had an elevated temperature was summarized. | All participants who received at least 1 study vaccination and had follow-up safety data. | Posted | Number | Percentage of Participants | Up to Day 5 after any vaccination |
|
|
|
| Primary | Percentage of Participants With an Injection-site Adverse Event | An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The parent/guardian of the participant was to record 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 (erythema, pain, and swelling) was summarized. | All participants who received at least 1 study vaccination and had follow-up safety data. | Posted | Number | Percentage of Participants | Up to Day 5 after any vaccination |
|
|
|
| Primary | Percentage of Participants With a Systemic Adverse Event | An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The parent/guardian of the participant was to record the presence of any VRC-prompted systemic AEs that occurred in the 5 days after any vaccination. The percentage of participants with a systemic AE was summarized. | All participants who received at least 1 study vaccination and had follow-up safety data. | Posted | Number | Percentage of Participants | Up to Day 15 after any vaccination |
|
|
|
| Primary | Percentage of Participants With a Serious Adverse Event | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (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, is a cancer, is an overdose, or is another important medical event. The percentage of participants that experienced 1 or more SAEs was summarized. | All participants who received at least 1 study vaccination and had follow-up safety data. | Posted | Number | Percentage of Participants | Up to Day 15 after any vaccination |
|
|
|
| Primary | Percentage of Participants With a Vaccine-related Serious Adverse Event | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (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, is a cancer, is an overdose, or is another important medical event. The percentage of participants that experienced 1 or more SAEs that were considered at least possibly related to the study vaccine was summarized. | All participants who received at least 1 study vaccination and had follow-up safety data. | Posted | Number | Percentage of Participants | Up to 30 months |
|
|
|
| Secondary | Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18 Participants Aged 9 to 15 Years Versus Participants Aged 16 to 26 Years | Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed mMU/mL. GMTs obtained for each anti-HPV from this study were compared to each of the ant-HPV GMTs obtained in study V501-122 (NCT NCT01862874) in which Japanese males 16 to 26 years received V501 in the same 3 dose regimen, to test a hypothesis that would demonstrate non-inferiority. | Participants 9 to 15 years old (PN200) or 16 to 26 years old (PN122) that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 7 serology result within 21 to 49 days post dose 3. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Four weeks postdose 3 (Month 7) |
|
|
|
|
| Secondary | Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 18 Months | Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed as mMU/mL. | All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 18 data within an acceptable date range of 12 months postdose 3. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | 12 months postdose 3 (18 months) |
|
|
|
| Secondary | Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 30 Months | Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed as mMU/mL. | All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 30 data within an acceptable date range of 24 months postdose 3. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | 24 months postdose 3 (30 months) |
|
|
|
| Secondary | Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 18 Months | Serum antibodies to HPV types were measured with a competitive luminex immunoassay. The serostatus cutoffs (mMU/mL) for HPV types were as follows: HPV Type 6: ≥20; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24 | All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 18 data within an acceptable date range of 12 months postdose 3. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 months postdose 3 (18 months) |
|
|
|
| Secondary | Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 30 Months | Serum antibodies to HPV types were measured with a competitive luminex immunoassay. The serostatus cutoffs (mMU/mL) for HPV types were as follows: HPV Type 6: ≥20; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24. | All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 30 data within an acceptable date range of 24 months postdose 3. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 24 months postdose 3 (30 months) |
|
|
|
| 100 |
| 0 |
| 100 |
| 67 |
| 100 |
| Injection site pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| D053918 |
| Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
| Title | Measurements |
|---|---|
|
| Anti-HPV 11 |
|
|
| Anti-HPV 16 |
|
|
| Anti-HPV 18 |
|
|
| Anti-HPV 11 | ANOVA | Log-transformed data using an analysis of variance model with a term for age-group | <0.001 | GMT Ratio | 2.30 | 2-Sided | 95 | 1.89 | 2.78 | GMT Ratio = GMT PN200 divided by GMT PN122 | Non-Inferiority | The statistical criterion for success requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type |
| Anti-HPV 16 | ANOVA | Log-transformed data using an analysis of variance model with a term for age-group | <0.001 | GMT Ratio | 1.69 | 2-Sided | 95 | 1.35 | 2.11 | GMT Ratio= GMT PN200 divided by GMT PN122 | Non-Inferiority | The statistical criterion for success requires that the lower bound of two-sided 95% CI of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type |
| Anti-HPV 18 | ANOVA | Log-transformed data using an analysis of variance model with a term for age-group | <0.001 | GMT Ratio | 3.05 | 2-Sided | 95 | 2.33 | 3.99 | GMT Ratio= GMT PN200 divided by GMT PN122 | Non-Inferiority | The statistical criterion for success requires that the lower bound of two-sided 95% CI of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type |
|
| Anti-HPV 16 |
|
|
| Anti-HPV 18 |
|
|
|
| Anti-HPV 16 |
|
|
| Anti-HPV 18 |
|
|
|
| Anti-HPV 16 |
|
|
| Anti-HPV 18 |
|
|
|
| Anti-HPV 16 |
|
|
| Anti-HPV 18 |
|
|