Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-02 @ 8:03 AM
Study NCT ID:
NCT06350058
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Clinical Trial of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old
Sponsor:
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Organization:
Study Overview
Official Title:
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evalution the Safety, Tolerability of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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 research objective is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity.
Detailed Description:
This is a Phase I, single center, randomized, double-blind, placebo-controlled, dose escalation clinical trial conducted in Hebei Province, China. The purpose of this study is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity.
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?: