Varicella
Conditions
Brief summary
This is an open-labelled 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 the single-dose primary immunization of live attenuated varicella vaccine on different time points ,and the safety and immunogenicity after the booster immunization
Detailed description
This study is an open-labelled phase Ⅲ clinical trial.The experimental vaccine manufactured by Sinovac(Dalian) Vaccine Technology Co., Ltd.A total of 1195 subjects who received vaccine in the phase Ⅲ lot-consistency clinical trial were be enrolled .All subjects except C0243 and C0556 were divided into 3 groups according to the order of study number.Subjects in 3 groups received a booster immunization of live attenuated varicella vaccines 1 year,2 years and 3 years after primary immunization,respectively.About 3.0ml of venous blood was collected from each enrolled subject at pre-booster immunization,30 days after booster immunization and the serum was separated for neutralizing antibody detection.The antibody levels were used to evaluate the immunity persistence and immunogenicity after booster immunization of live attenuated varicella vaccines .
Interventions
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.And the 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
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
2 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Received one dose live attenuated varicella vaccine in the phase Ⅲ lot-consistency clinical trial; * Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study.
Exclusion criteria
* Received one dose live attenuated varicella vaccine at the end of the phase Ⅲ lot-consistency 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-seroconversion rate of antibody | 1 year after primary immunization | seroconversion rates of antibody 1 year after primary immunization |
| Immunogenicity index-Seroconversion rate of antibody | 30 days after booster immunization | Seroconversion rate of the neutralizing antibody 30 days after booster immunization |
| Immunogenicity index-seropositivity rate of antibody | 30 days after booster immunization | Seropositivity rate of antibody 30 days after booster immunization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity index- GMI of the antibody | 30 days after booster immunization | GMI of the antibody 30 days after booster immunization |
| Safety index-Incidence of solicited local or systemic AE | within 14 days after vaccination | Incidence of solicited local or systemic AE within 14 days after vaccination |
| Immunogenicity index-Seropositivity rate of antibody | Before the booster dose immunization | Seropositivity rate of antibody before booster immunization |
| Safety index-Incidence of SAE | within 30 days after vaccination | Incidence of SAE within 30 days after vaccination |
| Safety index-Incidence of local or systemic AE | within 30 days after vaccination | Incidence of local or systemic AE within 30 days after vaccination |
| Immunogenicity index-GMT of the antibody | Before the booster dose immunization | GMT of the antibody before booster immunization |
| Immunogenicity index- GMT of the antibody | 30 days after booster immunization | GMT of the antibody 30 days after booster immunization |
Countries
China
Outcome results
None listed