Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B

PHASE3CompletedINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

October 13, 2020

Primary Completion Date

April 6, 2021

Study Completion Date

December 16, 2021

Conditions
ImmunogenicitySafety
Interventions
BIOLOGICAL

Recombinant Hepatitis B + DTP-HB-Hib

1 dose of 0.5 ml Recombinant Hepatitis B + 3 dose of 0.5 ml of DTP-HB-Hib

BIOLOGICAL

Hep B + Pentabio (registered)

1 dose of 0.5 ml Recombinant Hepatitis B (registered) + 3 dose of 0.5 ml of Pentabio (registered)

Trial Locations (3)

Unknown

Garuda Primary Health Centre, Bandung

Ibrahim Adjie Primary Health Centre, Bandung

Puter Primary Health Care, Bandung

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PT Bio Farma

INDUSTRY