Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447779
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-06-02
Brief Title:
Efficacy Safety and Immunogenicity Study of Recombinant Zoster VaccineCHO Cell in Adults Aged 40 Years and Older
Sponsor:
MAXVAX Biotechnology Limited Liability Company
Organization:
MAXVAX Biotechnology Limited Liability Company
Study Overview
Official Title:
A Multicenter Randomized Double-Blinded Placebo-Controlled Phase III Clinical Trial to Evaluate Efficacy Safety and Immunogenicity of Recombinant Zoster Vaccine CHO Cell in Adults Aged 40 Years and Above
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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 purpose of the sutdy is to evaluate efficacy safety and immunogenicity of Recombinant Zoster Vaccine CHO Cell with 2 doses at 2-month interval in adults aged 40 years and older
Detailed Description:
A total of 25000 adults aged 40 years and older will be enrolled stratified into 40-49 50-59 60-69 and 70 years of age All subjects will randomly receive investigational vaccine or placebo at a ratio of 11 Efficacy and safety will be assessed in all subjects while immunogenicity will be assessed in a subset of 1250 subjests in a selected trial site
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