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ENROLLING BY INVITATION
NCT05015686
PHASE3

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

Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

This a randomized, blind, controlled 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 of a two doses vaccination of investigational vaccine with 0,28 day, 0,42 day and 0,56 day immunization schedule in population aged ≥13 years old.

Official title: 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

Key Details

Gender

All

Age Range

13 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2400

Start Date

2021-09-30

Completion Date

2026-09-20

Last Updated

2024-03-08

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd

live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection

BIOLOGICAL

Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd

live varicella-zoster virus in trehalose,human serum albumin,sodium glutamate,sucrose,glucose,carbamide,arginine and injection water per injection

BIOLOGICAL

Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd

live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection

BIOLOGICAL

Placebo

Sodium chloride and distilled water

Locations (1)

Yucheng Center for Disease Control and Prevention

Shangqiu, Henan, China