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

Phase 3

Completed

• Conditions: Varicella

• Registration Number: NCT05150392
• Lead Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.

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 .

Study Timeline

• Study Start: 2018-07-11
• Primary Completion: 2018-08-11
• Study Completion: 2020-08-14
• Status Verified: 2021-11
• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-12-08
• Last Update Submitted: 2021-12-08
• Study First Posted: 2021-12-09
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1193

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Immunogenicity index-seropositivity rate of antibody	30 days after booster immunization	Seropositivity rate of antibody 30 days after booster immunization
Immunogenicity index-seroconversion rate of antibody	3 years after primary immunization	seroconversion rates of antibody 3 years 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

Secondary Outcome Measures

Name	Time	Method
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
Immunogenicity index-Seropositivity rate of antibody	Before the booster dose immunization	Seropositivity rate of antibody before booster immunization
Immunogenicity index- GMI of the antibody	30 days after booster immunization	GMI of the antibody 30 days after booster immunization
Safety index-Incidence of SAE	within 30 days after vaccination	Incidence of SAE within 30 days after vaccination
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
Safety index-Incidence of local or systemic AE	within 30 days after vaccination	Incidence of local or systemic AE within 30 days after vaccination

Trial Locations

Locations (1)

Xiangfu County Center for Disease Control and Prevention; 🇨🇳 Kaifeng, Henan, China