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NOT YET RECRUITING
NCT06690515
PHASE1/PHASE2

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

Sponsor: PT Bio Farma

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

6 Weeks - 11 Weeks

Study Type

INTERVENTIONAL

Enrollment

465

Start Date

2025-03-01

Completion Date

2026-09-30

Last Updated

2024-11-15

Healthy Volunteers

Yes

Interventions

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

Locations (3)

Garuda Primary Health Centre

Bandung, West Java, Indonesia

Ibrahim Adjie Priamry Health Centre

Bandung, West Java, Indonesia

Puter Primary Health Centre

Bandung, West Java, Indonesia