Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04921111
Status:
UNKNOWN
Last Update Posted:
2021-09-17
First Post:
2021-05-31
Brief Title:
A Phase I Safty and Immunogenicity Study of SCT1000 in Healthy Women Aged 18 to 45 Years
Sponsor:
Sinocelltech Ltd
Organization:
Sinocelltech Ltd
Study Overview
Official Title:
A Randomized Double-Blind Controlled Positive and Placebo Phase I Clinical Trial to Estimate Safty and Immunogenicity of the SCT1000 in Healthy Women Aged 18 to 45 Years
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 311Two 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 Gardasil9 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 9311Arm 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 311Two 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None