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

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

465

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

October 31, 2025

Study Completion Date

September 30, 2026

Conditions
Vaccine Adverse ReactionVaccine Reaction
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

Trial Locations (3)

Unknown

Garuda Primary Health Centre, Bandung

Ibrahim Adjie Priamry Health Centre, Bandung

Puter Primary Health Centre, Bandung

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Faculty of Medicine Universitas Padjadjaran

UNKNOWN

lead

PT Bio Farma

INDUSTRY