Viewing Study NCT06389513



Ignite Creation Date: 2024-05-06 @ 8:27 PM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06389513
Status: RECRUITING
Last Update Posted: 2024-06-24
First Post: 2024-04-24

Brief Title: Clinical Study of the Safety of Menhycia in 3-Month-Old Infants
Sponsor: CanSino Biologics Inc
Organization: CanSino Biologics Inc

Study Overview

Official Title: Phase IV Clinical Study of the Safety of Menhycia in 3-Month-Old Infants
Status: RECRUITING
Status Verified Date: 2024-04
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 study is an open multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia The study plan is to enroll approximately 3000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine and to administer a total of 3 doses of Menhycia with a minimum of 1 month between doses and a booster dose of 1 dose of immunization is allowed at 12 months of age
Detailed Description: None

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