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

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.

Conditions

• HPV InfectioN
• HPV-Related Carcinoma

Interventions

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

Sponsors & Collaborators

• Guangxi Center for Disease Control and Prevention

  collaborator OTHER_GOV

• Henan Center for Disease Control and Prevention

  collaborator OTHER_GOV

• Sichuan Center for Disease Control and Prevention

  collaborator OTHER_GOV

• Centers for Disease Control and Prevention, China

  collaborator OTHER_GOV

• Yunnan Center for Disease Control and Prevention

  collaborator OTHER

• Sinocelltech Ltd.

  lead INDUSTRY

Principal Investigators

• Yi Mo · Guangxi Center for Disease Control and Prevention

• Yan Zheng · Yunnan Center for Disease Control and Prevention

• Guohua Li · Centers for Disease Control and Prevention, China

• Ting Huang · Sichuan Center for Disease Control and Prevention

• Zhiqaing Xie · Henan Center for Disease Control and Prevention

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-08-13

Primary Completion

2024-03-31

Completion

2028-08-31

Countries

• China

Study Locations