This an open phase Ⅳ clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunity persistence of live attenuated varicella vaccine at 5 and 8 years after primary immunization with live attenuated varicella vaccine.
This study is an open phase Ⅳ clinical trial in subjects who enrolled in the clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 .The experimental vaccine and placebo (Freeze Dired Dilution) were manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.A total of 703 subjects will be enrolled including 349 subjects in experimental group and 354 subjects in control group .And 3.0-3.5ml of venous blood was collected from all subjects at 5 and 8 years after primary immunization, and the serum was separated for varicella antibody detection. The window period of blood collection was six months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
703
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 placebo (freeze dired dilution) was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. and contained no active ingredient.It was 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride and phosphate.
Xiangcheng County Center for Disease Control and Prevention
Xuchang, Henan, China
Biyang County Center for Disease Control and Prevention
Zhumadian, Henan, China
Immunogenicity index-seropositive rates of varicella antibody
The seropositive rates of varicella antibody in 5 years after primary immunization with varicella vaccine
Time frame: 5 years after primary immunization
Immunogenicity index-GMT of varicella antibody
GMT of varicella antibody in 5 years after primary immunization with varicella vaccine
Time frame: 5 years after primary immunization
Immunogenicity index-the seropositive rates of varicella antibody
The seropositive rates of varicella antibody in 8 years after primary immunization with varicella vaccine
Time frame: 8 years after primary immunization
Immunogenicity index-the GMT of varicella antibody
GMT of varicella antibody in 8 years after primary immunization with varicella
Time frame: 8 years after primary immunization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.