HPV Infection Vaccine Safety SCT1000
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGSCT1000
Recombinant 14 valent human papillomavirus vaccine (6,11,16,18,31,33,35,39,45,51,52,56,58,59) (insect cells)
DRUGGardasil®9
Recombinant 9 or 4 valent human papillomavirus vaccine
DRUGplacebo
aluminium phosphate
DRUGGardasil®
Recombinant 4 valent human papillomavirus vaccine
Sponsors
Sinocelltech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
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；
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 |
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 |
| Abnormal hematology and chemistry laboratoty values 3 days after each dose | 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 |
Countries
China
Contacts
Primary ContactFengcai Zhu, Master
Outcome results
None listed