Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the safety of a novel recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast ) with different dose in healthy females between 9-45 years of age at enrollment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Group 1, HPV vaccine 0.5ml | Experimental | 20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 0.5ml experimental HPV vaccines. |
|
| Adult Group 1, Placebo 0.5ml | Placebo Comparator | 20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 0.5ml aluminum phosphate. |
|
| Adult Group 2, HPV vaccine 1.0ml | Experimental | 20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 1.0ml experimental HPV vaccines. |
|
| Adult Group 2, Placebo 1.0ml | Placebo Comparator | 20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 1.0ml aluminum phosphate. |
|
| Children Group 1, HPV vaccine 0.5ml | Experimental | 20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 0.5ml experimental HPV vaccines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV 16/18 vaccine, 0,5ml | Biological | Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions. | 7 days after each vaccine dose | |
| Occurrence, intensity and relationship to vaccination of any unsolicited symptom. | 30 days after finish vaccinations |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibody responses of HPV 16/18 after each vaccine dose. | 30 days after finish vaccinations |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yan-ping Li, MD | Guangxi Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GuangXi Center for Diseases Control and Prevention | Nanning | Guangxi | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 13, 2016 | |
| Reset | May 18, 2016 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Children Group 1, Placebo 0.5ml | Placebo Comparator | 20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 0.5ml aluminum phosphate. |
|
| Children Group 2, HPV vaccine 1.0ml | Experimental | 20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 1.0ml experimental HPV vaccines. |
|
| Children Group 2, Placebo 1.0ml | Placebo Comparator | 20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 1.0ml aluminum phosphate. |
|
| Placebo control, 0.5ml | Biological | Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule. |
|
| HPV 16/18 vaccine, 1.0ml | Biological | Subjects were planned to receive HPV vaccine 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule |
|
| Placebo control, 1.0ml | Biological | Subjects were planned to receive three doses of the placebo control 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule. |
|
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 13, 2016 | May 18, 2016 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| 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 |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided