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To evaluate the safety and Immunogenicity of 15-valent HPV vaccine in 9-45year-old participants.
A Randomized, double-blind, placebo and positive controlled trial is planned in 330 healthy participants across two age groups (18-45 years and 9-17 years) to evaluate the safety and immunogenicity of the 15-valent HPV vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medium dose for 15-HPV vaccine | Experimental | Participants aged 9-45 years were given 3 doses of medium dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule |
|
| High dose for 15-HPV vaccine | Experimental | Participants aged 9-45 years were given 3 doses of high dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule |
|
| Placebo | Placebo Comparator | Participants aged 9-45 years were given 3 doses of placebo intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule |
|
| 9-HPV-vaccine | Active Comparator | Participants aged 18-45 years were given 3 doses of 9-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medium dose for 15-HPV vaccine | Biological | Participants aged 9-45 years were given 3 doses of medium dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule |
| 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 | Percentage of Participants With Unsolicited Adverse Events | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity after receiving 3 doses of 15-HPV vaccine | Geometric mean titer (GMT) of anti-vaccine containing corresponding type of neutralizing antibody in subjects aged 18-45 years on the 31-day after the third dose of immunization | Up to 31 days after the third vaccination |
| Immunogenicity of 15-HPV vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dabin Liang | Contact | +86 15977783657 | gxirb2018@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Mo, Master | Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention | Recruiting | Nanning | Guangxi | 530028 | China |
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| High dose for 15-HPV vaccine | Biological | Participants aged 9-45 years were given 3 doses of high dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule |
|
| Placebo | Biological | Participants aged 9-45 years were given 3 doses of placebo intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule |
|
| 9-HPV vaccine | Biological | Participants aged 9-45 years were given 3 doses of 9-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule |
|
Seroconversion rate (SCR)of the anti-vaccine containing the corresponding type of neutralizing antibody on day 31 after total immunization in subjects aged 18-45 years |
| Up to 31 days after the third vaccination |
| Immunogenicity after receiving 3 doses of 15-HPV vaccine among the participants | Geometric Mean Fold Increase (GMI) and 4-fold increase rates of anti-vaccine corresponding types of neutralizing antibodies in baseline seropositive subjects aged 18-45 years at day 31 after immunization | Up to 31 days after the third vaccination |
| 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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