Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-25 @ 1:46 PM
Study NCT ID:
NCT05150392
Status:
COMPLETED
Last Update Posted:
2021-12-09
First Post:
2021-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: