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NCT06062238

Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Trial to Assess the Prophylactic Efficacy, Safety, and Immunogenicity of the Investigational M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine When Administered Intramuscularly on a 0,1-month Schedule to Adolescents and Adults
Bill & Melinda Gates Medical Research Institute·Phase 3·ClinicalTrials.gov·biologicalNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Tuberculosis
Drug/Device/Intervention
M72/AS01E-4 Mycobacterium tuberculosis investigational vaccine
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Bill & Melinda Gates Medical Research Institute
Location
Bandung,Depok,Jakarta,Jakarta,Jakarta,Ahero,Eldoret,Kericho,Kilifi,Kisumu,Machakos,Mombasa,Nairobi,Nairobi,Chichiri,Lilongwe,Manhica,Maputo,Bloemfontein,Brits,Cape Town,Cape Town,Cape Town,Cape Town,C, Indonesia,Kenya,Malawi,Mozambique,South Africa,Vietnam,Zambia
Timeline & enrollment
Phase
Phase 3
Start date
Feb 01, 2024
End date
Aug 01, 2029
Enrollment
26000 participants
Primary outcome

IGRA-Positive Cohort: Number of participants with laboratory-confirmed pulmonary tuberculosis (TB)

Summary

The study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial to
 assess the prophylactic efficacy, safety, and immunogenicity of the investigational
 M72/AS01E-4 Mtb vaccine when administered intramuscularly (IM) on a 0,1-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.

ICD-10 classifications
TuberculosisLatent tuberculosisTuberculosis of other organsCongenital tuberculosisSequelae of tuberculosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06062238
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06062238 through Pure Global AI's free database. This Phase 3 trial is sponsored by Bill & Melinda Gates Medical Research Institute and is currently Not yet recruiting. The study focuses on Tuberculosis. Target enrollment is 26000 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.