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A randomized, double-blind and placebo-controlled phase I study to evaluate the safety and immunogenicity of a 9-valent Human Papillomavirus (HPV) vaccine, administered intramuscularly according to a 0, 2, 6-month schedule in 9 to 45 years old healthy Chinese females.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV vaccine | Experimental | Subjects receive 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule. |
|
| Placebo | Placebo Comparator | Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV Vaccine | Biological | Intramuscular injection, 3 doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed including pain, redness, swelling, induration and itching. | During a 8-day period (Day 0-7) following each vaccination |
| Percentage of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction | During a 8-day period (Day 0-7) following each vaccination |
| Percentage of Subjects Reporting Unsolicited Adverse Events (AEs) | An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. | Within 31 days (Day 0-30) after any vaccination |
| Percentage of Subjects Reporting Serious Adverse Events (SAE) | Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | Throughout the study period (up to Month 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Seroconversion is defined as a participant who was anti-HPV seronegative at Day 0 (before vaccination) and became seropositive 30days after the third dose (Month 7). | 30 days after the third dose (Month 7) |
| Geometric Mean Titers (GMT) of HPV serotype-specific antibody |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xuecheng LIU, BS | Sichuan Provincial Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Provincial Center for Disease Prevention and Control | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D002583 | Uterine Cervical Neoplasms |
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Placebo |
| Drug |
Intramuscular injection, 3 doses |
|
HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 specific antibodies GMT |
| 30 days after the third dose (Month 7) |
| 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 |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |