NCT05470855

Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Anhui Province

A Clinical Trial to Evaluate Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Children Aged 1-12 Years

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45,400 (estimated)
• Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd. · Industry
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not 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 protective effect of varicella vaccine in children aged 1-12 years and the correlation between varicella antibody and protective effect,to evaluate the immunogenicity and safety of varicella vaccine in children aged 1-12 years.

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 four parts,and A total of 45400 subjects will be enrolled. Study 1,45000 subjects including 15000 subjects aged 1-3 years with no history of varicella vaccination ,15000 subjects aged 4-6 years with a history of 1 dose of varicella vaccine,15000 subjects aged 7-12 years with a history of 1 dose of varicella vaccine will be enrolled to evaluate protective effect of varicella vaccine. There will be 7500 subjects in the experimental group and 7500 in the control group in each age group.And subjects who voluntarily receive varicella vaccine will be included in the experimental group and other subjects will be included in the control group.All subjects in the experimental group will receive one dose of varicella vaccine. Study 2,400 healthy children including 100 subjects aged 1-3 years with no history of varicella ,150 subjects aged 4-6 years(50 children with no history of varicella vaccination and 100 children with a history of one dose of varicella vaccine),150 subjects aged 7-12 years (50 children with no history of varicella vaccination and 100 children with a history of one dose of varicella vaccine),each subject will receive one or two doses (0,3 months) of varicella vaccine. Study 3,30000 subjects from study 1 will be enrolled to conduct safety observation study,all adverse events of all subjects will be collected. Study 4,Herpes fluid collected from study 1 varicella cases will be used to conduct etiological study on the pathogenic strains of varicella cases.

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.

Timeline

• Start date: 2022-07-06
• Primary completion: 2022-11-30
• Completion: 2023-02-10
• First posted: 2022-07-22
• Last updated: 2023-01-12

Locations

5 sites across 1 country: China