NCT06041061

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SCT1000 in Healthy Women Aged 18-45 Years

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Efficacy, Safety, and Immunogenicity of a 14- Valent Recombinant Human Papillomavirus Vaccine (SCT1000) in Healthy Women Aged 18-45 Years

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18,000 (actual)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Introduction: SCT1000 is a recombinant 14-valent human papillomavirus vaccine (insect cell) that covers all 12 WHO-recognized high-risk oncogenic HPV subtypes Indications are for the prevention of cervical, vulvar, vaginal, and anal cancers, and genital warts caused by HPV6, HPV11 and HPV11 in females 9-45 years of age, as well as intraepithelial neoplasia and AIS. Intraepithelial neoplasia and AIS and genital warts due to HPV6 and HPV11. Aim:To evaluate the protective efficacy of 3 doses of HPV vaccine (SCT1000) for the prevention of HPV type 6,11,16,18,31,33,35,39,45,51,52,56,58,59-associated lesions in healthy females aged 18-45 years compared with placebo. Design: A Multicenter, Randomized, Double-blind, Placebo-controlled phase III Clinical trial Subject Information: a total of 18000 healthy women aged 18-45 years selected by inclusion and exclusion criteria. Cluster situation: a ratio of 1:1 between the experimental group and the placebo group. End point index: relative index with efficacy, safety, and immunogenicity of SCT1000

Conditions

• HPV InfectioN
• HPV-Related Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant 14-Valent Human Papillomavirus Vaccine（Insect Cell）	According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine
BIOLOGICAL	placebo	According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo

Timeline

• Start date: 2023-08-13
• Primary completion: 2024-03-01
• Completion: 2028-08-01
• First posted: 2023-09-18
• Last updated: 2023-09-18

Locations

5 sites across 1 country: China