drugset / Trial / NCT06690515
Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants
Phase 1/2
Not yet recruiting
465 enrolled
PT Bio Farma
Faculty of Medicine Universitas Padjadjaran · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
This trial is open label, comparative, randomized, phase I/II study, experimental, randomized, open-label, three arm parallel group study. The primary objective for phase I is to evaluate the safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose. The primary objective for phase II is to evaluate protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine.
Timeline
- Start
- 2025-03-01
- Primary completion
- 2025-10-31
- Completion
- 2026-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | DTwP-Hepatitis B-Hib Vaccine | Vaccine | 0.5 ml | Intramuscular |
| Subject | DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A | Vaccine | 0.5 ml | Intramuscular |
| Subject | DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B | Vaccine | 0.5 ml | Intramuscular |
| Comparator | IPV (Sinovac)® | Vaccine | 0.5 ml | Intramuscular |