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| Name | Class |
|---|---|
| Walvax Biotechnology Co., Ltd. | INDUSTRY |
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This study will evaluate the immunogenicity and safety of Zerun 9-valent HPV recombinant vaccine in healthy female 16-26 years of age by comparing with GARDASIL®9.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zerun HPV-9 | Experimental | Subjects receive 3 doses of Zerun HPV-9 vaccine |
|
| GARDASIL®9 | Active Comparator | Subjects receive 3 doses of GARDASIL®9 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zerun HPV-9 | Biological | Zerun 9-valent Human Papillomarivus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Pichia Pastoris), 0.5mL, three doses, 0,2,6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMT) of HPV neutralizing antibodies | HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 neutralizing antibodies GMT | 30 days postdose 3 (Month 7) |
| Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Seroconversion is defined as a participant in PPS who was anti-HPV seronegative at Day 0 (before vaccination) and became seropositive 30days after the third dose (Month 7). | 30 days postdose 3 (Month 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects reporting solicited local symptoms | Solicited local symptoms assessed including pain, redness, swelling, induration and pruritus. | 0-7 days after each dose |
| Percentage of subjects reporting solicited general symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GuangXi Center for Diseases Control and Prevention | Nanning | Guangxi | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D003218 | Condylomata Acuminata |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| GARDASIL ®9 | Biological | GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months |
|
Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction
| 0-7 days after each dose |
| 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. | 0-30 days after each dose |
| Percentage of subjects reporting serious adverse events (SAEs) | 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. | Month 0 to Month 12 |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |