465
Participants
Start Date
March 1, 2025
Primary Completion Date
October 31, 2025
Study Completion Date
September 30, 2026
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
Garuda Primary Health Centre, Bandung
Ibrahim Adjie Priamry Health Centre, Bandung
Puter Primary Health Centre, Bandung
Lead Sponsor
Faculty of Medicine Universitas Padjadjaran
UNKNOWN
PT Bio Farma
INDUSTRY