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A phase 1 random, double blind, positive and placebo control trail was conducted in 120 healthy women in the arm A: 18-26 years old and Arm B: 27-45 years old. The 40 subjects to be inoculated with low, middle, and high dose vaccinefirst in sequence if there was no safety issue. In each dose group SCT1000 : placebo: positive =3:1:1.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 vaccination of this dose group or higher dose group will not be carried out, and the study of other dose groups will continue. If this happens at a low dose, the study will be suspended / terminated.
Arm A: 18-26 years old. Random, double blind, Gardasil®9 positive control and placebo control was conducted in 120 healthy women in the arm. The first group was 40 subjects to be inoculated with low dose vaccine; After the first low dose group was completed, the safety observation was conducted 7 days after the first dose was completed. If there was no need to suspend / terminate the study, 40 subjects in the group were continued to receive the medium dose vaccine; After the first dose group was completed, the safety observation was 7 days after the first dose was completed. If there was no need to suspend / terminate the test, 40 subjects in the group were inoculated with high dose group. In each dose group SCT1000 : placebo: Gardasil® 9=3:1:1.Arm B: 27-45 years old. Random, double blind, Gardasil® positive control and placebo control was conducted in 120 healthy women in the arm. The first group was 40 subjects to be inoculated with low dose vaccine; After the first dose of the low dose group was completed, the safety observation was conducted 7 days after the first dose was completed. If there was no need to suspend / terminate the study, 40 subjects in the group were continued to be inoculated in the medium dose vaccine; After the first dose group was completed, the safety observation was 7 days after the first dose was completed. If there was no need to suspend / terminate the test, 40 subjects in the group were inoculated with high dose group. SCT1000 in each dose group: placebo: Gardasil® =3:1:1.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 vaccination of this dose group or higher dose group will not be carried out, and the study of other dose groups will continue. If this happens at a low dose, the study will be suspended / terminated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Women Aged 18 to 26 Years | Experimental | 120 healthy women aged18 to 26 years are in this arm. The first group was 40 subjects to be inoculated with low dose vaccine; After the first low dose group was completed, the safety observation was conducted 7 days after the first dose was completed. If there was no need to suspend / terminate the study, 40 subjects in the group were continued to receive the medium dose vaccine; After the first dose group was completed, the safety observation was 7 days after the first dose was completed. If there was no need to suspend / terminate the test, 40 subjects in the group were inoculated with high dose group. In each dose group SCT1000 : Gardasil®9 : placebo =3:1:1. |
|
| Healthy Women Aged 27 to 45 Years | Experimental | 120 healthy women aged 27 to 45 years are in this arm. The first group was 40 subjects to be inoculated with low dose vaccine; After the first low dose group was completed, the safety observation was conducted 7 days after the first dose was completed. If there was no need to suspend / terminate the study, 40 subjects in the group were continued to receive the medium dose vaccine; After the first dose group was completed, the safety observation was 7 days after the first dose was completed. If there was no need to suspend / terminate the test, 40 subjects in the group were inoculated with high dose group. In each dose group SCT1000 : Gardasil® : placebo =3:1:1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCT1000 | Drug | Recombinant 14 valent human papillomavirus vaccine (6,11,16,18,31,33,35,39,45,51,52,56,58,59) (insect cells) |
|
| 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 |
| 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 |
| Abnormal hematology and chemistry laboratoty values 3 days after each dose |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria of first injection
Exclusion criteria for 2nd or 3rd dose vaccination
Healthy Women Aged 18 to 45 Years
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fengcai Zhu, Master | Contact | 8625-83759984 | jszfc@vip.sina.com |
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| 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 |
|---|---|
| C012714 | aluminum phosphate |
| 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 | Drug | Recombinant 9 or 4 valent human papillomavirus vaccine |
|
|
| placebo | Drug | aluminium phosphate |
|
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| Gardasil® | Drug | Recombinant 4 valent human papillomavirus vaccine |
|
|
Changes in laboratory test indicators (including white blood cell count, lymphocyte count, neutrophils, platelets, hemoglobin, ALT, AST, total bilirubin, fasting blood glucose, creatinine) 3 days after vaccination |
| 3 days after each dose |
| 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. |
| 27503625 | Result | Palmieri B, Poddighe D, Vadala M, Laurino C, Carnovale C, Clementi E. Severe somatoform and dysautonomic syndromes after HPV vaccination: case series and review of literature. Immunol Res. 2017 Feb;65(1):106-116. doi: 10.1007/s12026-016-8820-z. |
| D053918 |
| Papillomavirus Vaccines |
| D014765 | Viral Vaccines |