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| Name | Class |
|---|---|
| Chengdu Institute of Biological Products Co.,Ltd. | INDUSTRY |
| Simoon Record Pharma Information Consulting Co., Ltd. | INDUSTRY |
| Guangxi Center for Disease Control and Prevention | OTHER_GOV |
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A total of 480 Chinese women aged 18-26 years old were enrolle,experimental group and the control group were randomly assigned in a ratio of 3:1. 360 Chinese women in the experimental group and 120 in the control group. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or control vaccine according to the 0, 2, and 6 months immunization program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaccine group | Experimental |
| |
| Positive control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological/Vaccine: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) | Biological | Inject vaccine produced by ChinaVaccineSerum, containing HPV antigen protein, 270μg/1ml per bottle |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HPV neutralizing antibodies GMT | 30 days after full immunization | |
| Anti-HPV neutralizing antibody positive conversion rate(after full immunization 30 days) | 30 days after full immunization | |
| Collect all SAEs | Vaccine-related and unrelated | through study completion, an average of 13 months |
| Collect AEs incidence | Vaccine-related and unrelated | Within 30 minutes of injection |
| Collect AEs incidence | All AEs: incidence of AEs related to vaccines and unrelated The rate of Solicited for AE Non-collective AEs: incidence of AEs related to vaccines and unrelated AE level 3 and above: incidence of vaccine-related and unrelated AEs | Within 30 days after inoculation |
| collect AEs leading subject to withdrawal | Incidence of vaccine-related and unrelated AEs | through study completion, an average of 13months |
| collect All pregnancy conditions and pregnancy outcomes | collect pregnant woman Anti-HPV neutralizing antibody positive conversion rate and Anti-HPV neutralizing antibodies GMT | through study completion, an average of 13 months |
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Inclusion Criteria:
First dose exclusion criteria:
12.Body temperature before inoculation≥37.3℃(armpit body temperature); 13. People who have a systolic blood pressure ≥140mmHg and/or a diastolic blood pressure ≥90mmHg before enrollment; 14. Participate or plan to participate in other clinical trials (drugs, vaccines and medical devices) during the study; 15. Plan to move out of the local area before the end of the study or leave the area for a long time during the scheduled study visit;
Exclusion criteria for second and third doses of vaccination:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liucheng Center for Disease Control and Prevention | Liuzhou | Guangxi | China |
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| Beijing Kantorico Statistical Technology Co., Ltd. | UNKNOWN |
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| 9-valent HPV vaccine(Gardasil 9) | Biological | Inject Gardasil 9 , containing HPV antigen protein, 270μg/0.5ml per bottle |
|
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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| ID | Term |
|---|---|
| D001688 | Biological Products |
| ID | Term |
|---|---|
| D045424 | Complex Mixtures |
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