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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_003 |
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To prove that quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine is generally safe and well tolerated in the Chinese population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Open Label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine | Biological | HPV 6,11,16,18 VLP, 0.5 mL 1 dose injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Vaccination | All adverse experiences were collected from the time the consent form was signed through 14 days following the vaccination. All subjects were requested to record injection-site adverse experiences and monitor temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after injection | For serious adverse experiences and systemic adverse experiences: 14 days follow-up after one dose of vaccination; For injection-site adverse experiences: 5 days follow-up after one dose of vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | 18 to 26 Years of Age Group | 18 to 26 years of age group was enrolled to evaluate safety firstly. Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine. |
| FG001 | 9 to 17 Years of Age Group | 9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data. Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 18 to 26 Years of Age Group | 18 to 26 years of age group was enrolled to evaluate safety firstly. Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine. |
| BG001 | 9 to 17 Years of Age Group |
| 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 | Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Vaccination | All adverse experiences were collected from the time the consent form was signed through 14 days following the vaccination. All subjects were requested to record injection-site adverse experiences and monitor temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after injection | Posted | Number | Participants | For serious adverse experiences and systemic adverse experiences: 14 days follow-up after one dose of vaccination; For injection-site adverse experiences: 5 days follow-up after one dose of vaccination |
|
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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 | 18 to 26 Years of Age Group | 18 to 26 years of age group was enrolled to evaluate safety firstly. Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site painness | General disorders | 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 |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| 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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9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data. Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Temperature | Mean | Standard Deviation | Degrees Celsius |
|
| Pulse | Mean | Standard Deviation | Beats per minute (BPM) |
|
| OG001 | 9 to 17 Years of Age Group | 9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data. Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine. |
|
|
| 0 |
| 20 |
| 10 |
| EG001 | 9 to 17 Years of Age Group | 9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data. Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine. | 0 | 20 | 11 |
| Headache | Nervous system disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Menstrual disorder | Reproductive system and breast disorders | Systematic Assessment |
|
| Allergic reaction | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Muscle pain | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Hypodynamia | General disorders | Systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| 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 |