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

NCT05015686 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2400

Last updated 2024-03-08

No results posted yet for this study

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.

Conditions

  • Varicella

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

Sponsors & Collaborators

  • Sinovac (Dalian) Vaccine Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lili Huang, Bachelor · Henan Provincial Center for Disease Prevention and Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2022-02-09
Completion
2026-09-20

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05015686 on ClinicalTrials.gov