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

> **NCT06690515** · PHASE1,PHASE2 · NOT_YET_RECRUITING · sponsor: **PT Bio Farma** · enrollment: 465 (estimated)

## Conditions studied

- Vaccine Adverse Reaction
- Vaccine Reaction

## Interventions

- **BIOLOGICAL:** DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A
- **BIOLOGICAL:** DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B
- **BIOLOGICAL:** Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)®

## Key facts

- **NCT ID:** NCT06690515
- **Lead sponsor:** PT Bio Farma
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2025-03-01
- **Primary completion:** 2025-10-31
- **Final completion:** 2026-09-30
- **Target enrollment:** 465 (ESTIMATED)
- **Last updated:** 2024-11-15

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06690515

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06690515, "Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT06690515. Licensed CC0.

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