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A phase II random, double blind, positive and placebo control trail was conducted in 1200 healthy women in the arm A: 18-26 years old and 600 healthy women in the Arm B: 27-45 years old. The 1800 subjects to be inoculated with middle, and high dose vaccine. Middle dose SCT1000: hight dose SCT1000: placebo: positive control =1:1:1:1.Two arms can be recruited at the same time. If the DSMB assessment shows that the adverse events of a certain dose group meet the criteria of suspension / termination, the dose group will be suspended / terminated.
Arm A: 18-26 years old. Random, double blind, Gardasil®9 positive control and placebo control was conducted in 1200 healthy women. Middle dose SCT1000: hight dose SCT1000: placebo: positive control =1:1:1:1.Arm B: 27-45 years old. Random, double blind, Gardasil® positive control and placebo control was conducted in 600 healthy women. Middle dose SCT1000: hight dose SCT1000: placebo: positive control =1:1:1:1.Two arms can be recruited at the same time. If the DSMB assessment shows that the adverse events of a certain dose group meet the criteria of suspension / termination, the dose group will be suspended / terminated, and the study of other dose groups will continue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Women Aged 18 to 26 Years | Active Comparator | 1200 healthy women aged18 to 26 years are in this arm. Middle dose SCT1000 : hight dose SCT1000:Gardasil®9 : placebo =1:1:1:1. SCT1000 and Gardasil®9 will be immunized at 0, 2, and 6 months, respectively. |
|
| Healthy Women Aged 27 to 45 Years | Active Comparator | 600 healthy women aged 27 to 45 years are in this arm. Middle dose SCT1000 : hight dose SCT1000:Gardasil® : placebo =1:1:1:1. SCT1000 and Gardasil®9 will be immunized at 0, 2, and 6 months, respectively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCT1000 | Biological | HPV vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of local reaction AEs | Occurrence of local reaction AEs up to 7 days following each dose | Up to 7 days following each dose |
| Occurrence of systemic AEs | Occurrence of systemic AEs up to 7 days following each dose | Up to 7 days following each dose |
| Occurrence of AEs | Occurrence of AEs from dose1 to 30 days after each dose | From dose1 to 30 days after each dose |
| - Compare the geometric average titer (GMT) | GMT | From dose1 to 1 months after dose3 |
| serum antibody impotence 1 | serum antibody impotence rate | From dose1 to 1 months after dose3 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of SAEs | Occurrence of SAEs from dose1 to 30 days after each dose and from dose1 to 12 months after first dose | From dose1 to 30 days after each dose and from dose1 to 12 months after first dose |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for 2nd or 3rd dose vaccination
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fengcai Zhu, Master | Contact | 8625-83759984 | jszfc@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Fengcai Zhu | Jiangsu Province CDC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guanyun Country CDC | Recruiting | Nanjing | Jiangsu | 222200 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21142263 | Result | McCormack PL, Joura EA. Quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Gardasil(R)): a review of its use in the prevention of premalignant genital lesions, genital cancer and genital warts in women. Drugs. 2010 Dec 24;70(18):2449-74. doi: 10.2165/11204920-000000000-00000. | |
| 16753240 | Result |
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| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Gardasil®9 | Biological | HPV vaccine |
|
| Gardasil® | Biological | HPV vaccine |
|
| placebo | Other | adjuvent |
|
| Villa LL, Ault KA, Giuliano AR, Costa RL, Petta CA, Andrade RP, Brown DR, Ferenczy A, Harper DM, Koutsky LA, Kurman RJ, Lehtinen M, Malm C, Olsson SE, Ronnett BM, Skjeldestad FE, Steinwall M, Stoler MH, Wheeler CM, Taddeo FJ, Yu J, Lupinacci L, Railkar R, Marchese R, Esser MT, Bryan J, Jansen KU, Sings HL, Tamms GM, Saah AJ, Barr E. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18. Vaccine. 2006 Jul 7;24(27-28):5571-83. doi: 10.1016/j.vaccine.2006.04.068. Epub 2006 May 15. |
| D053918 |
| Papillomavirus Vaccines |
| D014765 | Viral Vaccines |