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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,800
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
- Compare the geometric average titer (GMT)
GMT
Time frame: From dose1 to 1 months after dose3
serum antibody impotence 1
serum antibody impotence rate
Time frame: From dose1 to 1 months after dose3
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
adjuvent