Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06062238
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-09-25
Brief Title:
Study to Assess Efficacy and Safety of M72AS01E-4 Mycobacterium Tuberculosis Mtb Vaccine in Adolescents and Adults
Sponsor:
Bill Melinda Gates Medical Research Institute
Organization:
Bill Melinda Gates Medical Research Institute
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Placebo-controlled Multicenter Clinical Trial to Assess the Prophylactic Efficacy Safety and Immunogenicity of the Investigational M72AS01E-4 Mycobacterium Tuberculosis Mtb Vaccine When Administered Intramuscularly on a 01-month Schedule to Adolescents and Adults
Status:
RECRUITING
Status Verified Date:
2024-10
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 study is a randomized double-blind placebo-controlled multicenter clinical trial to assess the prophylactic efficacy safety and immunogenicity of the investigational M72AS01E-4 Mtb vaccine when administered intramuscularly IM on a 01-month schedule to adolescents and adults This trial will be conducted in 3 cohorts Interferon gamma release assay IGRA-positive Cohort IGRA-Negative Cohort and Human Immunodeficiency virus HIV Cohort
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