Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372665
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Brief Title:
Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization
Sponsor:
Liaoning Chengda Biotechnology CO LTD
Organization:
Liaoning Chengda Biotechnology CO LTD
Study Overview
Official Title:
Safety Observation of the Vero Cell-derived Inactivated Japanese Encephalitis Vaccine JEV-I Given With Primary Immunization in a Large Amount of Healthy Children Aged 8 Months and Older
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 is a single-arm non-randomized open-label post-marketing safety observation study The purpose of this study is to investigate the safety of JEV-I given with primary immunization in a large amount of healthy children aged 8 months and older
Detailed Description:
Healthy children aged 8 months and older who choose to receive the study vaccine for primary immunization at their own expense in Jiangsu Province will be invited to participate in this study No study vaccine will be supplied or administered as part of this study participants will be monitored following vaccine administration in clinical settings
The primary immunization program with JEV-I requires 2 intramuscular doses administered 7-10 days apart All participants will be observed for the incidence of any adverse events AEs within 30 minutes and from 30 minutes to 7 days after each vaccination including local and systemic reactions Additionally all participants will be observed for unsolicited AEs within 30 days after after each vaccination
The primary immunization program with JEV-I requires 2 intramuscular doses administered 7-10 days apart All participants will be observed for the incidence of any adverse events AEs within 30 minutes and from 30 minutes to 7 days after each vaccination including local and systemic reactions Additionally all participants will be observed for unsolicited AEs within 30 days after after each vaccination
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