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This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable immune response to all human papillomavirus (HPV) strains contained in the vaccine. The success criterion for the primary analysis requires that point estimates for seroconversion rate be greater than 90% for all 9 HPV types.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Enrolled | Experimental | 9-valent human papillomavirus (9vHPV) L1 VLP vaccine (V503), 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V503 | Biological | V503 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine | Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). 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, and HPV Type 58: ≥8. | 4 weeks post-vaccination 3 (Month 7) |
| Percentage of Participants With an Injection-site Adverse Event (AE) | 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 study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded. | up to 5 days after any vaccination |
| Percentage of Participants With a Non-Injection Site (Systemic) AE | 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 study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs. | up to 15 days after any vaccination |
| Percentage of Participants With a Vaccine-related AE | 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 study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Adverse experience that is judged by the Investigator to be "definitely related," "probably related," or "possibly related" to the study drug is defined as a vaccine-related AE. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine | Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL. | 4 weeks post-vaccination 3 (Month 7) |
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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 |
|---|---|---|---|
| 28003597 | Result | Iwata S, Murata S, Rong Han S, Wakana A, Sawata M, Tanaka Y. Safety and Immunogenicity of a 9-Valent Human Papillomavirus Vaccine Administered to 9- to 15-Year-Old Japanese Girls. Jpn J Infect Dis. 2017 Jul 24;70(4):368-373. doi: 10.7883/yoken.JJID.2016.299. Epub 2016 Dec 22. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled | 9-valent human papillomavirus (9vHPV) L1 VLP vaccine (V503), 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| up to 15 days after any vaccination |
| Vaccination 1 |
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| Vaccination 2 |
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| Vaccination 3 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled | 9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. |
| 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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| 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 Who Seroconvert to Each of the HPV Types Contained in the Vaccine | Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). 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, and HPV Type 58: ≥8. | Participants who received all 3 vaccinations and met criteria for Per Protocol Immunogenicity (PPI) Population (not a general protocol violator, received all vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range) for at least 1 of the 9 HPV types. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 4 weeks post-vaccination 3 (Month 7) |
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| Primary | Percentage of Participants With an Injection-site Adverse Event (AE) | 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 study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded. | Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data. | Posted | Number | Percentage of Participants | up to 5 days after any vaccination |
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| Primary | Percentage of Participants With a Non-Injection Site (Systemic) AE | 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 study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs. | Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data. | Posted | Number | Percentage of Participants | up to 15 days after any vaccination |
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| Primary | Percentage of Participants With a Vaccine-related AE | 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 study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Adverse experience that is judged by the Investigator to be "definitely related," "probably related," or "possibly related" to the study drug is defined as a vaccine-related AE. | Safety Population, which consists of all participants who received at least one vaccination and had available follow-up data. | Posted | Number | Percentage of Participants | up to 15 days after any vaccination |
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| Secondary | Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine | Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL. | Participants who received all 3 vaccinations and met criteria for Per Protocol Immunogenicity (PPI) Population (not a general protocol violator, received all vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range) for at least 1 of the 9 HPV types. | Posted | Geometric Mean | 95% Confidence Interval | milli Merck units/mL | 4 weeks post-vaccination 3 (Month 7) |
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Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Serious AEs and Non-serious non-injection site AEs) and up to 30 months (Any death and serious drug-related AEs)
Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.
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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 | All Enrolled | 9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. | 0 | 100 | 96 | 100 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA Version 16.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA Version 16.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA Version 16.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 16.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment |
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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. Sponsor review can be expedited to meet publication timelines
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Title | Measurements |
|---|---|
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| Anti-HPV 18 (n=98) |
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| Anti-HPV 31 (n=97) |
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| Anti-HPV 33 (n=98) |
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| Anti-HPV 45 (n=99) |
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| Anti-HPV 52 (n=99) |
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| Anti-HPV 58 (n=95) |
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