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ACTIVE NOT RECRUITING
NCT06041061
PHASE3

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

Sponsor: Sinocelltech Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

18000

Start Date

2023-08-13

Completion Date

2028-08

Last Updated

2023-09-18

Healthy Volunteers

Yes

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

Locations (5)

Guangxi Center for Disease Control and Prevention

Nanning, Guangxi, China

Henan Center for Disease Control and Prevention

Zhengzhou, Henan, China

Shanxi Center for Disease Control and Prevention

Taiyuan, Shanxi, China

Sichuan Center for Disease Control and Prevention

Chengdu, Sichuan, China

Yunan Center for Disease Control and Prevention

Kunming, Yunan, China