Clinical trial NCT05150392: An Open-labelled Clinical Trial of Live Attenuated Varicella Vaccines to Evaluate the Immunity Persistence After Primary Immunization and Safety and Immunogenicity After the Booster Immunization
Official title: An Open-labelled Clinical Trial,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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicella
Lead sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-09
Enrollment: 1193
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Immunogenicity index-seroconversion rate of antibody
timeFrame: 1 year after primary immunization
measure: Immunogenicity index-seroconversion rate of antibody
timeFrame: 2 years after primary immunization
measure: Immunogenicity index-seroconversion rate of antibody
timeFrame: 3 years after primary immunization
measure: Immunogenicity index-Seroconversion rate of antibody
timeFrame: 30 days after booster immunization
measure: Immunogenicity index-seropositivity rate of antibody
timeFrame: 30 days after booster immunization
Secondary outcomes:
measure: Immunogenicity index-Seropositivity rate of antibody
timeFrame: Before the booster dose immunization
measure: Immunogenicity index-GMT of the antibody
timeFrame: Before the booster dose immunization
measure: Immunogenicity index- GMT of the antibody
timeFrame: 30 days after booster immunization
measure: Immunogenicity index- GMI of the antibody
timeFrame: 30 days after booster immunization
measure: Safety index-Incidence of solicited local or systemic AE
timeFrame: within 14 days after vaccination
measure: Safety index-Incidence of local or systemic AE
timeFrame: within 30 days after vaccination
measure: Safety index-Incidence of SAE
timeFrame: within 30 days after vaccination
Other outcomes:
Locations:
city: Kaifeng
country: China
facility: Xiangfu County Center for Disease Control and Prevention
state: Henan
Study officials:
affiliation: Henan Provincial Center for Disease Control and Prevention
name: Shengli Xia, Master
role: PRINCIPAL_INVESTIGATOR
References: