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NCT06690515
Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants
Phase 1, PHASE2 trial testing DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A in Vaccine Adverse Reaction in 465 participants. Not yet recruiting.
31 October 2025
Quick facts
| Lead sponsor | PT Bio Farma |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 465 |
| Start date | 1 March 2025 |
| Primary completion | 31 October 2025 |
| Estimated completion | 30 September 2026 |
| Sites | 3 locations across Indonesia |
Drugs / interventions tested
- DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A — full drug profile →
- DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B — full drug profile →
- Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)® — full drug profile →
Conditions studied
- Vaccine Adverse Reaction — all drugs for Vaccine Adverse Reaction →
- Vaccine Reaction — all drugs for Vaccine Reaction →
Sponsor
PT Bio Farma — full company profile →
Who can join
Adults 6 Weeks to 11 Weeks, any sex, with Vaccine Adverse Reaction or Vaccine Reaction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06690515
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Vaccine Adverse Reaction
Currently open trials in the same condition.
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- NCT05898464 — Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV · Phase 4 · active not recruiting
- NCT06286488 — Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza · Phase 4 · active not 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
- 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
- NCT05727215 — Heterologous Booster Study of COVID-19 Protein Subunit Recombinant Vaccine in Children 12-17 Years of Age · Phase 2 · 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 NCT06690515 (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: 15 November 2024
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/NCT06690515.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing