Varicella
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
BIOLOGICALPlacebo (Freeze Dired Dilution)
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.
Sponsors
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects in PPS immunogenicity subgroup of phase Ⅲ clinical trial of protective effect of varicella vaccine; * The subject and/or guardian can understand and voluntarily sign the informed consent form; * Proven legal identity.
Exclusion criteria
* History of chickenpox or shingles; * History of varicella vaccination since phase Ⅲ clinical trial; * Autoimmune disease or immunodeficiency / immunosuppression; * History of immunosuppressive therapy since phase Ⅲ clinical trial; * According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity index-seropositive rates of varicella antibody | 5 years after primary immunization | The seropositive rates of varicella antibody in 5 years after primary immunization with varicella vaccine |
| Immunogenicity index-GMT of varicella antibody | 5 years after primary immunization | GMT of varicella antibody in 5 years after primary immunization with varicella vaccine |
| Immunogenicity index-the seropositive rates of varicella antibody | 8 years after primary immunization | The seropositive rates of varicella antibody in 8 years after primary immunization with varicella vaccine |
| Immunogenicity index-the GMT of varicella antibody | 8 years after primary immunization | GMT of varicella antibody in 8 years after primary immunization with varicella |
Countries
China
Outcome results
None listed