drugset / Trial / NCT06041061
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SCT1000 in Healthy Women Aged 18-45 Years
Phase 3
Active not recruiting
18000 enrolled
Sinocelltech Ltd.
Centers for Disease Control and Prevention, China · collabGuangxi Center for Disease Control and Prevention · collabHenan Center for Disease Control and Prevention · collabSichuan Center for Disease Control and Prevention · collabYunnan Center for Disease Control and Prevention · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
A total of 18000 healthy women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 36-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.
Timeline
- Start
- 2023-08-13
- Primary completion
- 2024-03
- Completion
- 2028-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SCT1000 | Vaccine | — | Intramuscular |