Trials / Completed
CompletedNCT04351685
Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants
A Multicenter, Phase III, Double-blind, Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Mycobacterium Tuberculosis Infection in Newborn Infants
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 6,940 (actual)
- Sponsor
- Serum Institute of India Pvt. Ltd. · Industry
- Sex
- All
- Age
- 0 Days – 14 Days
- Healthy volunteers
- Accepted
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.
Detailed description
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. Healthy male or female newborn infants will be centrally randomized to receive the allocated vaccine, stratified by the HIV status of the mother. Single dose of VPM1002 or BCG SII will be administered (within 14 days of birth) strictly intradermally.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-11-09
- Primary completion
- 2024-10-30
- Completion
- 2024-10-30
- First posted
- 2020-04-17
- Last updated
- 2025-02-10
Locations
12 sites across 5 countries: Gabon, Kenya, South Africa, Tanzania, Uganda
Source: ClinicalTrials.gov record NCT04351685. Inclusion in this directory is not an endorsement.