Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564116
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years and Above
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Active Comparator Clinical Trial to Evaluate Safety and Immunogenicity of Thiomersal-free Recombinant Hepatitis E Vaccine Escherichia Coli in People Ages 16 Years and Above
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and non-inferior immunogenicity of thiomersal-free Recombinant Hepatitis E Vaccine Escherichia Coli compared with licensed Recombinant Hepatitis E Vaccine Escherichia Coli when administered in participants ages 16 years and above
Detailed Description:
This is a single-center randomized double-blind active-comparator study to evaluate the safety and immunogenicity of thiomersal-free Recombinant Hepatitis E Vaccine Escherichia Coli in participants ages 16 years and above Sex male female and age 16-40 years old 41 years old and above are used as stratified factors Participants are randomly assigned in a 11 ratio to receive three doses of thiomersal-free hepatitis E vaccine or licensed hepatitis E vaccine intramuscularly at Month 0 1 and 6 The vaccine safety is assessed from the 1st dose vaccination to 6 months after the last dose vaccination Serum samples are collected for anti-HEV IgG determination at Month 0 and 7
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None