A Phase II Study of SCT1000 in Healthy Women Aged 18 to 45 Years

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05060484
Study type	Interventional
Source	Sinocelltech Ltd.
Contact	Fengcai Zhu, Master
Phone	8625-83759984
Email	jszfc@vip.sina.com
Status	Recruiting
Phase	Phase 2
Start date	October 19, 2021
Completion date	July 31, 2022

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