Interventional, Prevention, Randomized
Conditions
Keywords
HPV, woman
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALSCT1000
HPV vaccine
BIOLOGICALGardasil®9
HPV vaccine
BIOLOGICALGardasil®
HPV vaccine
OTHERplacebo
adjuvent
Sponsors
Sinocelltech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Female aged between 18 and 45 years at the first vaccination; * Be able to understand and comply with the request of the protocol, and sign written informed consent; - Be able to read, understand and complete diary card; * According to the medical history and the results of physical examination and laboratory examination, the subjects were judged to be in good health * Women who agree to use effective contraception throughout the study period；
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of local reaction AEs | Up to 7 days following each dose | Occurrence of local reaction AEs up to 7 days following each dose |
| Occurrence of systemic AEs | Up to 7 days following each dose | Occurrence of systemic AEs up to 7 days following each dose |
| Occurrence of AEs | From dose1 to 30 days after each dose | Occurrence of AEs from dose1 to 30 days after each dose |
| - Compare the geometric average titer (GMT) | From dose1 to 1 months after dose3 | GMT |
| serum antibody impotence 1 | From dose1 to 1 months after dose3 | serum antibody impotence rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of SAEs | From dose1 to 30 days after each dose and from dose1 to 12 months after first dose | Occurrence of SAEs from dose1 to 30 days after each dose and from dose1 to 12 months after first dose |
Countries
China
Contacts
Primary ContactFengcai Zhu, Master
Outcome results
None listed