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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
240
Recombinant 14 valent human papillomavirus vaccine (6,11,16,18,31,33,35,39,45,51,52,56,58,59) (insect cells)
Recombinant 9 or 4 valent human papillomavirus vaccine
aluminium phosphate
Recombinant 4 valent human papillomavirus vaccine
Guanyun Country CDC
Nanjing, Jiangsu, China
RECRUITINGOccurrence of local reaction AEs
Occurrence of local reaction AEs up to 7 days following each dose
Time frame: Up to 7 days following each dose
Occurrence of systemic AEs
Occurrence of systemic AEs up to 7 days following each dose
Time frame: Up to 7 days following each dose
Occurrence of AEs
Occurrence of AEs from dose1 to 30 days after each dose
Time frame: From dose1 to 30 days after each dose
Occurrence of SAEs
Occurrence of SAEs from dose1 to 30 days after each dose and from dose1 to 12 months after first dose
Time frame: 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
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
Time frame: 3 days after each dose
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