NCT05158777

Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old

A Randomized, Blind, Controlled Clinical Trial to Evaluate Safety and Immunogenicity of Live Attenuated Varicella Vaccine After a Two-dose Vaccination Course in Healthy Population Aged ≥13 Years Old

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,480 (actual)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, blind, controlled clinical trial of live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd. The purpose of this study is to evaluate the immunogenicity and safety of a two doses vaccination of investigational vaccine with 0,28 day and 0,56 day immunization schedule in population aged ≥13 years old.

Detailed description

This study is a randomized, blind, controlled phase III clinical trial in population aged ≥13 years old. The experimental vaccine will be manufactured by Shanghai Institute of Biological Products Co.,Ltd.. A total of 2480 subjects aged 13 years and older will be enrolled with 1240 subjects in 13\~17 years old group and1240 subjects in 18 years and older group. 1240 subjects in each age group would be randomly divided into experimental group and control group according to 1:1 ratio, and subjects will receive two doses of vaccine with the immunization course of 0,28 days or 0,56 days. In addition, 400 subjects from experimental group (100 subjects per subgroup) would be selected to collect blood at 3 and 5 years after immunization to evaluate immune persistence of live attenuated varicella vaccines.

Conditions

• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd.	live varicella-zoster virus in 0.5 mL of sucrose, sodium chloride, potassium chloride, sodium glutamate, phosphate and injection water per injection
BIOLOGICAL	Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd	live varicella-zoster virus in 0.5 mL of mannitol, dextrose tincture, sucrose, trehalose, human serum albumin and injection water per injection

Timeline

• Start date: 2022-02-13
• Primary completion: 2022-11-14
• Completion: 2022-11-14
• First posted: 2021-12-15
• Last updated: 2023-12-29

Locations

1 site across 1 country: China