Ignite Creation Date:
2024-05-06 @ 6:27 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05664152
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-12-23
First Post:
2022-12-02
Brief Title:
An Open-label Bridging Study of BARYCELA Inj in Healthy Vietnamese Children Aged Between 12 Months to 12 Years
Sponsor:
GC Biopharma Corp
Organization:
GC Biopharma Corp
Study Overview
Official Title:
An Open-label Bridging Study to Assess the Safety and Immunogenicity of BARYCELA Inj Live Attenuated Varicella Vaccine for Injection in Healthy Vietnamese Children Aged Between 12 Months to 12 Years
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-12
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 goal of this bridging study is to assess the safety and immunogenicity of BARYCELA inj in healthy Vietnamese children aged between 12 months to 12 years The main questions it aims to answer are
Safety of BARYCELA inj Live attenuated varicella vaccine for injection
Immunogenicity of BARYCELA inj Live attenuated varicella vaccine for injection
Participants will be administered subcutaneously with a single dose05 mL dose of the BARYCELA injMG1111 on the upper arm brachia lateral
Safety of BARYCELA inj Live attenuated varicella vaccine for injection
Immunogenicity of BARYCELA inj Live attenuated varicella vaccine for injection
Participants will be administered subcutaneously with a single dose05 mL dose of the BARYCELA injMG1111 on the upper arm brachia lateral
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