Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma) (NCT05482282) | Clinical Trial Compass
WithdrawnPhase 3
Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)
Stopped: The products will be replace with others.
Indonesia0Started 2025-12
Plain-language summary
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).
Who can participate
Age range1 Day – 3 Days
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy, full term, newborns infants.
✓. Infant born after 37-42 weeks of pregnancy.
✓. Infant weighing 2500 gram or more at birth.
✓. Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
✓. Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.
Exclusion criteria
✕. Child concomitantly enrolled or scheduled to be enrolled in another trial.
✕. Child evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees on Day 0).
✕. Child suspected of allergy to any component of the vaccines (e.g. formaldehyde), based on anamnesis.
✕. Child suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis
✕. Newborn suspected of congenital or acquired immunodeficiency, based on anamnesis
✕. 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)).
✕. Child received other vaccination with the exception of BCG and poliomyelitis.
What they're measuring
1
To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma)