Trials / Completed
CompletedNCT05124340
Safety and Tuberculin Conversion Following BCG Vaccination
Safety and Tuberculin Conversion Following BCG Vaccine Vial (Bio Farma) Compared to Registered BCG Vaccine (Bio Farma) in Indonesian Infants
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 220 (actual)
- Sponsor
- PT Bio Farma · Industry
- Sex
- All
- Age
- 1 Day – 1 Month
- Healthy volunteers
- Accepted
Summary
The study is an bridging study, observer-blind, randomized, controlled prospective intervention study. The primary objective is evaluate the safety of BCG Vaccine Vial (Bio Farma).
Detailed description
This trial is bridging study, observer blinded, comparative, randomized study. Approximately 220 subjects will be recruited, 110 subjects are the investigational arm and 110 subjects are the active comparator arm. The objective of the study is to evaluate the safety of BCG Vaccine Vial (Bio Farma), and assess the the local and systemic reactions within 90 days after vaccination in each group, and assess the tuberculin conversion in each group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BCG vial vaccine | Intradermal injection |
| BIOLOGICAL | BCG ampoule vaccine | Intradermal injection |
Timeline
- Start date
- 2021-12-01
- Primary completion
- 2022-05-31
- Completion
- 2022-07-30
- First posted
- 2021-11-17
- Last updated
- 2022-09-19
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT05124340. Inclusion in this directory is not an endorsement.