NCT06690515

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 465 (estimated)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 6 Weeks – 11 Weeks
• Healthy volunteers: Accepted

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.

Detailed description

This trial is open label, comparative, randomized, phase I/II study. For phase I, approximately 75 subjects will be recruited and will seamlessly continue to phase II recruiting 390 subject, in total 465 subjects. In this study, DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine will be compared to an active control (Registered DTwP-Hepatitis B-Hib Vaccine and Registered Inactivated Polio Vaccine). There are 2 formulas of DTwP-Hepatitis B-Hib-IPV Vaccine which will be used in the study. The regimen of the vaccine is 0,5 ml injected three-dose regimen with 28 days interval between doses. On the other hand, the control group will receive 0,5 ml of Registered DTwP-Hepatitis B-Hib vaccine and 0,5 ml Inactivated Bio Farma vaccine injected in three-dose regimen with 28 days interval between doses. The safety and immunogenicity result of the Phase I study will determine the continuation of the next phase clinical trial. Clinical trial of phase II can be conducted after safety observation within 28 days after the third dose in phase I. Three hundred and ninety (390) healthy subjects aged 6-11 weeks of age will be recruited in Phase II trial.

Conditions

• Vaccine Adverse Reaction
• Vaccine Reaction

Interventions

Type	Name	Description
BIOLOGICAL	DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A	0,5 ml DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A injected three-dose regimen with 28 days interval between doses. Vaccine is injected intramuscularly in left anterolateral thigh.
BIOLOGICAL	DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B	0,5 ml injected of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B three-dose regimen with 28 days interval between doses. Injected intramuscularly in left anterolateral thigh.
BIOLOGICAL	Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)®	The control group will receive 0,5 ml of Registered DTwP-Hepatitis B-Hib vaccine and 0,5 ml IPV (Sinovac)® injected in three-dose regimen with 28 days interval between doses. Registered DTwP-Hepatitis B-Hib Vaccine are injected intramuscularly into the left antero-lateral thigh region. IPV (Sinovac)® vaccine are injected intramuscularly into the right mid-lateral thigh region

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-10-31
• Completion: 2026-09-30
• First posted: 2024-11-15
• Last updated: 2024-11-15

Locations

3 sites across 1 country: Indonesia