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Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants

NCT04351685 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6940

Last updated 2025-02-10

No results posted yet for this study

Summary

The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation) to assess the efficacy, safety and immunogenicity of VPM1002 against Mtb infection.

Conditions

  • Mycobacterium Tuberculosis Infection

Interventions

BIOLOGICAL

VPM1002

The active ingredient of the recombinant BCG vaccine, VPM1002 is Mycobacterium bovis A dose of 0.05 ml will be administered intradermally. Manufactured by the Serum Institute of India Pvt. Ltd., India Diluent: 1 ml of Water for injection/vial

BIOLOGICAL

BCG SII

Commercially available BCG vaccine from Serum Institute of India Pvt. Ltd. A dose of 0.05 ml will be administered intradermally. Manufactured by the Serum Institute of India Pvt. Ltd., India Diluent: 1 ml of Sodium Chloride for injection/vial Injection

Sponsors & Collaborators

  • Serum Life Science Europe GmbH

    collaborator INDUSTRY

  • Serum Institute of India Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr Prasad Kulkarni, MD · Serum Institute of India Pvt. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2024-10-30
Completion
2024-10-30

Countries

  • Gabon
  • Kenya
  • South Africa
  • Tanzania
  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04351685 on ClinicalTrials.gov