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| Name | Class |
|---|---|
| Xiamen Innovax Biotech Co., Ltd | INDUSTRY |
| Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | INDUSTRY |
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This phase ā ” clinical study was designed to evaluate the immunogenicity and safety of the novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged 18-55 years of age at enrollment. The study volunteers would be randomized to receive the 3 different formulations of the novel HPV vaccine or placebo vaccine (recombinant hepatitis E vaccine) administered intramuscularly according to a 0-1-6 month schedule. This is a double-blind study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dosage HPV Vaccine(1:1) | Experimental | Participants in this arm would receive low dosage HPV vaccine with virus-like particles type 6 and 11 at 1:1 ratio. |
|
| low dosage HPV Vaccine(1:2) | Experimental | Participants in this arm would receive low dosage HPV vaccine with virus-like particles type 6 and 11 at 1:2 ratio. |
|
| high dosage HPV Vaccine(1:1) | Experimental | Participants in this arm would receive high dosage HPV vaccine with virus-like particles type 6 and 11 at 1:1 ratio. |
|
| Hepatitis E vaccine,HecolinĀ® | Placebo Comparator | Participants in this arm would receive Hepatitis E vaccine,HecolinĀ® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low dosage HPV Vaccine(1:1) | Biological | Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HPV 6 and anti-HPV 11 seroconversion rates (type specific IgG antibody) | 7 months | |
| Anti-HPV 6 and anti-HPV 11 geometric mean concentrations (type specific IgG antibody) | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of serious adverse events throughout the study | All the serious adverse events throughout the study would be recorded. | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Zhang, Master | Xiamen University | Study Chair |
| Yuemei Hu, Bachelor | Jiangsu center for Disease Prevention and Control | Principal Investigator |
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| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
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| ID | Term |
|---|---|
| C577000 | hecolin |
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| low dosage HPV Vaccine(1:2) | Biological | Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:2 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month. |
|
| high dosage HPV Vaccine(1:1) | Biological | Participants would intramuscularly receive high dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month. |
|
| Hepatitis E vaccine,HecolinĀ® | Biological | Participants would intramuscularly receive Hepatitis E vaccine for 3 doses at 0, 1, 6 month. |
|
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| 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 |