Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-03-08 @ 3:19 AM
Study NCT ID:
NCT02965404
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2016-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety Study of Live Attenuated Varicella Vaccines in Healthy Adults, Adolescents and Children
Sponsor:
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Organization:
Study Overview
Official Title:
A Blind, Randomized and Controlled Clinical Trial to Evaluate the Safety of Live Attenuated Varicella Vaccines for Healthy Adults, Adolescents and Children
Status:
COMPLETED
Status Verified Date:
2016-11
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:
The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine in healthy adults, adolescents, and children.
Detailed Description:
This study is a randomized, blind, single-center, controlled phase I clinical trial. The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The positive control is a commercialized live attenuated varicella vaccine manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP), and the negative control is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. All participants are healthy, and will be randomly assigned into experimental group, positive control group, or negative control group in the ratio 1:1:1.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: