Comparison of Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B at Birth Dose Using New Hepatitis B Bulk (Bio Farma), in Indonesian Infants

Penta BS22

This bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. The primary objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma).

2025-01-01

2025-04-01

2025-07-01

Not yet recruiting

Early phase I

220

Inclusion Criteria: 1. Healthy, full term, newborns infants. 2. Infant born after 37-42 weeks of pregnancy. 3. Infant weighing 2500 gram or more at birth. 4. Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form. 5. Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial. Exclusion Criteria: 1. Child concomitantly enrolled or scheduled to be enrolled in another trial. 2. Child evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees on Day 0). 3. Child suspected of allergy to any component of the vaccines (e.g. formaldehyde), based on anamnesis. 4. Child suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis 5. Newborn suspected of congenital or acquired immunodeficiency, based on anamnesis 6. Child received or plans to receive any treatment likely to alter the immune response intravenous (immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks)). 7. Child received other vaccination with the exception of BCG and poliomyelitis. 8. Child has any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. 9. Mother with HbsAg and HIV positive (by rapid test within 30 days prior subject's birth) 10. Mother suspected of immunodeficiency disease based on anamnesis

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention study', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double (Participant, Investigator) Observer Blind : Investigational Product and Active Comparator are masking Lot number is masking', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 220, 'type': 'ESTIMATED'}}

2024-04-08