Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study Interchangeability Hep-B Vaccine Administered at Birth Dose
Sponsor: PT Bio Farma
Summary
This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.
Official title: Randomized, Double-Blind, Interchangeability Study of In-House Recombinant Hepatitis B (Bio Farma) at Birth Dose Followed by RRegistered DTwP-HepB-IPV-Hib (HEXASIIL) Vaccine in Indonesian Infants
Key Details
Gender
All
Age Range
0 Days - 3 Days
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2026-10
Completion Date
2027-07
Last Updated
2026-10-02
Healthy Volunteers
Yes
Interventions
In-house Hepatitis B Vaccine
0,5 ml In-House Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh
Registered Hepatitis B Vaccine
0,5 ml Registered Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh