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To evaluate the safety and tolerability of 15-valent HPV vaccine in 9-45year-old participants.
A phase 1 random, double blind, placebo control trail was plan to conducted in 72 healthy participants in the 2 age groups(18-45 years old and 9-17 years old). The 72 subjects to be inoculated with middle and high dose vaccine first in sequence if there was no safety issue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV-vaccine group | Experimental | According to the 0, 2, and 6 months immunization schedule, intramuscular injection of the upper arm deltoid muscle, 3 doses of the 15-HPV vaccine |
|
| Placebo group | Placebo Comparator | According to the 0, 2, and 6 months immunization schedule, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | immunization schedule:Month 0,Month 2,Month 6 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | AE of local and systemic reactions within 30 minutes after each dose | Up to 30 minutes after any vaccination |
| Percentage of Participants With Solicited Adverse Events | The percentage of participants with one or more solicited AEs was assessed. | Up to 14 days after any vaccination |
| Percentage of Participants With Unsolicited Adverse Events | The percentage of participants with one or more unsolicited AEs was assessed. | Up to 30 days after any vaccination |
| Percentage of Participants With Serious Adverse Events | The percentage of participants with one or more SAEs was assessed | From Day 0 after the first dose of vaccination to 6 months after the thrid dose |
| Percentage of Female Participants With Pregnancy Events | The percentage of participants with Pregnancy Events was assessed | From Day 0 after the first dose of vaccination to 6 months after the thrid dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LIRONG HUANG, Master | Guangxi Center for Disease Prevention and Crontrol | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention | Guangxi | China |
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| 15-valent recombinant human papillomavirus vaccine (Hansenulapolymorpha) |
| Biological |
immunization schedule:Month 0,Month 2,Month 6 |
|
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D003218 | Condylomata Acuminata |
| 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 |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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