NCT05460429

Immunogenicity, Safety and Protective Effect of Live Attenuated Varicella Vaccine and Study on Antibody Level and Etiology of Varicella Zoster Virus

An Open Clinical Trial to Evaluate Immunogenicity,Safety and Protective Effect of Live Attenuated Varicella Vaccine and a Clinical Trial on Antibody Level and Etiology of Varicella Zoster Virus in Zhejiang Province

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 37,920 (estimated)
• Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd. · Industry
• Sex: All
• Age: 59 Years
• Healthy volunteers: Accepted

Summary

This is Phase 4 clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunogenicity and safety of a single dose of varicella vaccine in healthy children aged 1-6 years with different varicella immunization histories, to evaluate the antibody level of varicella-zoster virus in healthy people aged 0-59 years in Zhejiang Province.

Detailed description

This study is Phase Ⅳ clinical trial.The experimental vaccine manufactured by Sinovac(Dalian) Vaccine Technology Co., Ltd.This clinical trial consists of five parts,and A total of 37920 subjects will be enrolled. Study 1,360 subjects including 120 subjects aged 1-3 years with no history of varicella vaccination ,240 subjects aged 4-6 years with a history of 1 dose of varicella vaccine will be enrolled to evaluate the immunogenicity and safety of varicella vaccine.All subjects will receive one dose of varicella vaccine. Study 2,2530 subjects aged 0-59 years old will be enrolled and will be collected venous blood to detect varicella antibody and conduct investigation of varicella antibody level in healthy people. Study 3,30000 subjects aged 1-12 years old will be enrolled to conduct safety observation study.All subjects will receive one dose of varicella vaccine and all adverse events of all subjects will be collected. Study 4,5000 subjects aged 1-12 years old will be enrolled to conduct protective effect study of varicella vaccine after exposure. Study 5,30 subjects aged 1-12 years old will be enrolled. Herpes fluid or pharyngeal swab samples of subjects will be collected to study the pathogenicity of varicella.

Conditions

• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	Live attenuated varicella vaccine	The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. Live attenuated varicella-virus in 0.5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride, sodium dihydrogen phosphate, potassium dihydrogen phosphate per injection.The routine of administration is intramuscular injection into deltoid region of the lateral upper arm. And the immunization schedule is one dose of live attenuated varicella vaccine on day 0.

Timeline

• Start date: 2022-07-30
• Primary completion: 2023-03-15
• Completion: 2023-05-15
• First posted: 2022-07-15
• Last updated: 2023-01-12

Locations

3 sites across 1 country: China