deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT01479972

Study to Evaluate Safety and Immunogenicity of VPM1002 in Comparison With BCG in Newborn Infants in South Africa

Phase II Open Label, Randomized, Controlled Study to Evaluate Safety and Immunogenicity of VPM1002 in Comparison With BCG in HIV-unexposed, BCG Naive Newborn Infants in South Africa

Sponsor: Children's Infectious Diseases Clinical Research Unit (KID-CRU), South Africa

Conditions Tuberculosis
Interventions BCG VPM1002
Updated 6 times since 2017 Last updated: Oct 28, 2013 Started: Nov 30, 2011 Primary completion: Nov 30, 2012 Completion: Nov 30, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Tuberculosis and is currently completed. Children's Infectious Diseases Clinical Research Unit (KID-CRU), South Africa leads this study, which shows 6 recorded versions since 2011 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Aug 2025 · 11 months · monthly snapshotCompleted~Aug 2025 – present · 11 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Aug 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Aug 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE2

    First recorded

Nov 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Children's Infectious Diseases Clinical Research Unit (KID-CRU), South Africa
  • HJ-CTC George, South Africa
  • Serum Life Science Europe GmbH
  • Triclinium Johannesburg, South Africa
  • University of Stellenbosch
Data source: Serum Life Science Europe GmbH

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations