# Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)

> **NCT05482282** · PHASE3 · WITHDRAWN · sponsor: **PT Bio Farma**

## Conditions studied

- Diphtheria Vaccine Adverse Reaction
- Tetanus Vaccine Adverse Reaction
- Pertussis Vaccine Adverse Reaction
- Haemophilus Influenzae Type B Vaccine Adverse Reaction
- Hepatitis B Vaccine Adverse Reaction

## Interventions

- **BIOLOGICAL:** Recombinant Hepatitis B new Bulk vaccine
- **BIOLOGICAL:** DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine
- **BIOLOGICAL:** Recombinant Hepatitis B vaccine (Registered BioFarma)
- **BIOLOGICAL:** Pentabio

## Key facts

- **NCT ID:** NCT05482282
- **Lead sponsor:** PT Bio Farma
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** WITHDRAWN
- **Start date:** 2025-12
- **Primary completion:** 2026-12
- **Final completion:** 2026-12
- **Target enrollment:** 0 (ACTUAL)
- **Why stopped:** The products will be replace with others.
- **Last updated:** 2025-06-05

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05482282

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05482282, "Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)". Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/clinical/NCT05482282. Licensed CC0.

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