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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 90 Chinese women aged 9-45 years old were divided into three age groups: 27-45 years old, 18-26 years old, and 9-17 years old. The experimental group and the placebo group were randomly assigned in a ratio of 2:1. Sixty patients had a placebo group of 30 patients. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experiment group | Experimental | According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine |
|
| placebo group | Placebo Comparator | According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) | Biological | Injection vaccine produced by ChinaVaccineSerum ,containing HPV antigen protein, 270μg/1ml/bottle |
| Measure | Description | Time Frame |
|---|---|---|
| AE of local and systemic reactions within 30 minutes after each dose | 30 min | |
| All active AEs within 0-7 days after each dose | Active AE: Local and systemic adverse reactions occurring within 0-7 days after each dose of vaccination | 7 days |
| All non-active collection AEs within 0-30 days after each dose | Adverse events other than active AE include solicitation adverse events reported in addition to the specified solicitation time window | 30 days |
| All SAEs within 6 months after the first dose is vaccinated | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer of neutralizing antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58, 59 and 68 30 days after full immunization (Geometric Mean Titer, GMT) | 7 months | |
| Neutralizing antibody positive rate of anti-HPV6, 11, 16, 18, 31, 33, 45, 52, 58, 59 and 68 antibodies 30 days after full immunization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liuzhou Center for Disease Control and Prevention | Liuzhou | Guangxi | China |
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| Beijing Kantorico Statistical Technology Co., Ltd. | UNKNOWN |
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| Placebo | Biological | Placebo |
|
| 7 months |
| 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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