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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05509049` - Precision Nudging Drives Wellness Visit Attendance at Scale	N/A
Active, not recruiting	`NCT05667974` - A Study to Evaluate a PIKA Rabies Vaccine（Vero Cell）for Human Use,Freeze-dried	Phase 3
Not yet recruiting	`NCT06335121` - Implementation of PrEP Care Among Women in Family Planning Clinics	N/A
Not yet recruiting	`NCT04082091` - Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention
Terminated	`NCT01395238` - Enhancing Father's Ability to Support Their Preschool Child	N/A
Completed	`NCT00589173` - An Interactive Preventive Health Record (IPHR) to Promote Patient-Centered Preventive Care	N/A
Completed	`NCT00535665` - Safety and Immunogenicity of an Inactivated Pandemic Influenza Vaccine	Phase 2
Completed	`NCT00814554` - Effectiveness Evaluation of Three Strategies of Promotion of Healthy Dietary and Physical Activity Behaviours to Prevent Weight Excess Among Teenagers	N/A
Completed	`NCT00995462` - Prevention of Weight Gain in University Students	N/A
Completed	`NCT00966212` - Parent Education for Young Teen Females	Phase 2/Phase 3
Completed	`NCT04526873` - Encouraging Annual Wellness Visits Among ACO Beneficiaries	N/A
Recruiting	`NCT06112249` - SAFE Workplace Intervention for People With IDD	N/A
Completed	`NCT04977700` - Using Physical Tracking to Predict Sunburn	N/A
Completed	`NCT04032145` - Characterization of Health Conditions of Visitors of the Montreal Museum of Fine Arts
Completed	`NCT04785599` - Lymphedema Prevention After Lymph Node Emptying	N/A
Recruiting	`NCT05050266` - Enhancing Mental and Physical Health of Women Veterans	N/A
Recruiting	`NCT01021488` - Rosuvastatin for Preventing Deep Vein Thrombosis	Phase 4
Terminated	`NCT02247258` - Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence.	Phase 2
Recruiting	`NCT05903885` - A Cross-sectional Partnership to Improve Prevention	N/A
Completed	`NCT04162977` - Adapting Personality-Targeted Interventions for Reducing Substance Misuse and Related Outcomes in Youth in Youth Protection Services	N/A