# Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa

> **NCT04975178** · PHASE3 · RECRUITING · sponsor: **Biofabri, S.L** · enrollment: 7120 (estimated)

## Conditions studied

- Tuberculosis

## Interventions

- **BIOLOGICAL:** MTBVAC
- **BIOLOGICAL:** BCG

## Key facts

- **NCT ID:** NCT04975178
- **Lead sponsor:** Biofabri, S.L
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2022-10-17
- **Primary completion:** 2029-02
- **Final completion:** 2029-02
- **Target enrollment:** 7120 (ESTIMATED)
- **Last updated:** 2025-02-10

## Collaborators

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04975178

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04975178, "Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa". Retrieved via AI Analytics 2026-06-16 from https://api.ai-analytics.org/clinical/NCT04975178. Licensed CC0.

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