Tuberculosis
Conditions
Sponsors
Serum Institute of India Private Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A. Maternal 1. Age: 18 years or older at screening 2. No symptoms or signs of active TB at the time of participant’s enrolment. 3. Parent / guardian who intends to remain in the area with the child and should be reachable by phone during the trial period. B. Infant 1. Healthy male or female newborn infant. 2. Birth weight of at least 2,300 g. 3. Test negative for HIV by PCR at screening if born to an HIV-infected mother.
Exclusion criteria
Exclusion criteria: A. Maternal 1. Any reported or suspected substance abuse during pregnancy. 2. House-hold contact with active TB (defined as residing in the same house as an individual with active TB) within the 3 months prior to enrolment. B. Infant 1. Fever at the time of enrolment. 2. Clinically suspected sepsis. 3. Any malignant condition. 4. Any clinically significant severe congenital malformation, which may interfere with the evaluation of the safety, efficacy or immunogenicity of the vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To demonstrate that VPM1002 is non-inferior to BCG SII in providing protection against incident Mycobacterium tuberculosis (Mtb) infection. 2. To demonstrate that VPM1002 is superior to BCG SII in providing protection against incident Mtb infection. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the safety and tolerability profile of VPM1002 and BCG SII administered as a single dose to newborn infants. 2. To compare the efficacy of VPM1002 versus BCG SII in terms of the protective effects against tuberculosis (TB) disease. 3. To compare the efficacy of VPM1002 versus BCG SII in terms of the protective effects against sustained Mtb infection. | — |
Countries
Gabon, Kenya, South Africa, Tanzania, Uganda
Contacts
Public ContactSajjad Desai
Deputy Medical Director
Outcome results
None listed