NCT05060484

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

A Randomized, Double-Blind, Controlled (Positive and Placebo) Phase II Clinical Trial to Estimate Safty and Immunogenicity of the SCT1000 in Healthy Women Aged 18 to 45 Years

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,800 (estimated)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Interventional
• Prevention
• Randomized

Interventions

Type	Name	Description
BIOLOGICAL	SCT1000	HPV vaccine
BIOLOGICAL	Gardasil®9	HPV vaccine
BIOLOGICAL	Gardasil®	HPV vaccine
OTHER	placebo	adjuvent

Timeline

• Start date: 2021-10-19
• Primary completion: 2022-05-31
• Completion: 2022-07-31
• First posted: 2021-09-29
• Last updated: 2021-10-28

Locations

1 site across 1 country: China