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NCT05124340
Safety and Tuberculin Conversion Following BCG Vaccination
Phase 2 trial testing BCG vial vaccine in BCG Vaccination Reaction in 220 participants. Completed in 30 July 2022.
31 May 2022
Quick facts
| Lead sponsor | PT Bio Farma |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 220 |
| Start date | 1 December 2021 |
| Primary completion | 31 May 2022 |
| Estimated completion | 30 July 2022 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- BCG vial vaccine — full drug profile →
- BCG ampoule vaccine — full drug profile →
Conditions studied
- BCG Vaccination Reaction — all drugs for BCG Vaccination Reaction →
Sponsor
PT Bio Farma — full company profile →
Who can join
Adults 1 Day to 1 Month, any sex, with BCG Vaccination Reaction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05124340
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for BCG Vaccination Reaction
Currently open trials in the same condition.
- NCT05591339 — Diabetes Diagnosis, Management, Prevention and Education in Guinea-Bissau · Phase 4 · active not recruiting
- NCT05387655 — Long Term Effects of BCG Vaccination on Infectious and Immune Mediated Diseases · active not recruiting
- NCT04899765 — Measles and BCG Vaccines for Mother and Child · Phase 4 · recruiting
Other PT Bio Farma trials
Trials by the same sponsor.
- NCT06921460 — Long-Term Protection of Vi Antibodies Induced by Bio TCV in Indonesian Population Compared to PQed TCV · not yet recruiting
- NCT06690515 — Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in · Phase 1, PHASE2 · not yet recruiting
- NCT06690502 — Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination · completed
- NCT05933278 — Homologous Booster Study of COVID-19 Protein Subunit Recombinant Vaccine · Phase 2 · completed
- NCT06114641 — Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05124340 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PT Bio Farma
- Last refreshed: 19 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05124340.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing