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Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults - Trial NCT06062238

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.

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NCT06062238
Phase 3
Not yet recruiting
biological
Trial Details
ClinicalTrials.gov • NCT06062238
View on ClinicalTrials.gov
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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

Study Focus

Tuberculosis

M72/AS01E-4 Mycobacterium tuberculosis investigational vaccine

Interventional

biological

Sponsor & Location

Bill & Melinda Gates Medical Research Institute

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 3

Feb 01, 2024

Aug 01, 2029

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

Tuberculosis
Latent tuberculosis
Tuberculosis of other organs
Congenital tuberculosis
Sequelae of tuberculosis

Data Source

ClinicalTrials.gov

NCT06062238

Non-Device Trial