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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 II clinical study was designed to evaluate the immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter called HPV vaccine), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults aged 18-45 years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV Vaccine,270μg/1.0ml | Experimental | Participants in this arm would receive 270μg/1.0ml HPV vaccines. |
|
| Placebo | Placebo Comparator | Participants in this arm would receive 1.0ml aluminium adjuvant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV Vaccine,270μg/1.0ml | Biological | HPV vaccine (270μg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody) | To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level on day 0 (before the 1st dose) and one month after dose 3 | month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited local adverse reactions | Solicited local adverse reactions occurred within 7 days after each vaccination; | During the 7-day (Day 0-6) period following each vaccination |
| Solicited systematic adverse reactions |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7 (type specific IgG antibody) | To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific IgG antibody level on day 0 (before the 1st dose) and one month after dose 3 | month 7 |
| Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations in a immunogenicity subgroup at Months 1,2 and 7 (type specific neutralizing antibody and IgG antibody) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Zhang, Master | Xiamen University | Study Chair |
| Yue-Mei Hu, Bachelor | Jiangsu Provincial Centre for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Centre for Disease Control and Prevention | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
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| Placebo | Biological | Aluminium adjuvant (1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule. |
|
|
Solicited systematic adverse reactions occurred within 7 days after each vaccination;
| During the 7-day (Day 0-6) period following each vaccination |
| Unsolicited adverse events | Unsolicited adverse reactions occurred within 30 days after each vaccination; | Within 30 days (Day 0-29) after any vaccination |
| Serious adverse events | Serious adverse events occurred throughout the study; | throughout the study period, an average of 7 months |
To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing and IgG antibody level of a immunogenicity subgroup at month 1,2 and 6. |
| month 1,2 and 6 |
| 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 |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |