Clinical Trial

Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants

Not Yet Recruiting Phase 1/2
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Record status
This record was last updated November 15, 2024 (before its estimated October 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06690515
Lead Sponsor PT Bio Farma
Collaborators: Faculty of Medicine Universitas Padjadjaran
Conditions Vaccine Adverse Reaction, Vaccine Reaction
Enrollment 465 participants
Start Date 2025-03-01
Primary Completion 2025-10-31 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2024-11-15