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NOT YET RECRUITING
NCT07854847
PHASE3

Study Interchangeability Hep-B Vaccine Administered at Birth Dose

Sponsor: PT Bio Farma

View on ClinicalTrials.gov

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

BIOLOGICAL

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

BIOLOGICAL

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