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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
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
Conditions
Interventions
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.
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.
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