Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-20 @ 2:49 PM
Study NCT ID:
NCT01812135
Status:
WITHDRAWN
Last Update Posted:
2021-07-29
First Post:
2013-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of EV71 Vaccine With or Without Aluminum Adjuvant in Infants
Sponsor:
Sinovac Biotech Co., Ltd
Organization:
Study Overview
Official Title:
A Double-blind and Randomized, Phase II -02 Study With Inactivated EV71 Vaccines in Healthy Infants
Status:
WITHDRAWN
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on the previous study results, inactivated EV71 vaccine with aluminum adjuvant was elected to be used for the efficacy Phase III study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized, double-blind, phase II-02 clinical trial is to evaluate the safety and immunogenicity of an inactivated EV71 vaccine with or without aluminum adjuvant
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: