Ignite Creation Date:
2024-07-17 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484686
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
An Immunity Persistence Study of Booster Dose of Live Attenuated Varicella Vaccine
Sponsor:
Sinovac Dalian Vaccine Technology Co Ltd
Organization:
Sinovac Dalian Vaccine Technology Co Ltd
Study Overview
Official Title:
An Open-label Clinical Trial to Evaluate the Immunity Persistence of Live Attenuated Varicella Vaccine at 6 and 10 Years After Booster Dose Immunization With Live Attenuated Varicella Vaccine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 an open-label phase Ⅳ clinical trial of live attenuated varicella vaccine manufactured by Sinovac Dalian Vaccine Technology Co LtdThe purpose of this study is to evaluate the immunity persistence of live attenuated varicella vaccine at 6 and 10 years after booster dose
Detailed Description:
A total of 792 subjects aged 2 to 6 years including in per-protocol set PPS of immunogenicity assessment from previous phase Ⅲ clinical trial were enrolled About 30ml of venous blood was collected at 6 and 10 years after booster immunization for antibody detection
Study Oversight
Has Oversight DMC:
None
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?:
None