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| Name | Class |
|---|---|
| Yuxi Zerun Biotechnology Co., Ltd. | UNKNOWN |
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The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of bivalent HPV (Type 16,18) vaccine (Pichia pastoris) in healthy female subjects aged 9 - 30 years, and demonstrate the non-inferiority of the candidate HPV vaccine manufactured at commercial scale compared with a pilot scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2vHPV Consistency Lot 1 | Experimental |
| |
| 2vHPV Consistency Lot 2 | Experimental |
| |
| 2vHPV Consistency Lot 3 | Experimental |
| |
| 2vHPV Pilot Scale Lot | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris) | Biological | sterile solution for intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) for HPV-16 and/or HPV-18 at one month post 3rd dose | At Month 7 | |
| Percentage of participants who seroconvert to HPV-16 and/or HPV-18 at one month post 3rd dose | Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:40 prior to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:40 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. | At Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAE) during 30 days after each dose | 0~30 days after each vaccination | |
| Incidence of solicited adverse events (AEs) after vaccination | 0~7 days after each vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ting Huang | Sichuan Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mianyang Center for Disease Control and Prevention | Mianyang | Sichuan | China |
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| 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 |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Incidence of unsolicited AEs after vaccination | 0~30 days after each vaccination |
| Incidence of serious adverse events (SAEs) | Month 0 to 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 |