Status:
COMPLETED
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B
Lead Sponsor:
PT Bio Farma
Conditions:
Immunogenicity
Safety
Eligibility:
All Genders
Up to 3 years
Phase:
PHASE3
Brief Summary
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B
Detailed Description
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infant...
Eligibility Criteria
Inclusion
- 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
- Child concomitantly enrolled or scheduled to be enrolled in another trial.
- Mother with HBsAg positive.
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature \>37.5C on Day 0).
- Suspected of allergy to any component of the vaccines (e.g. formaldehyde).
- Suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- Newborn suspected of congenital or acquired immunodeficiency (including HIV infection).
- Received or plans to receive any treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks)).
- Received other vaccination with the exception of BCG and poliomyelitis.
- Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
Key Trial Info
Start Date :
October 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2021
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04071379
Start Date
October 13 2020
End Date
December 16 2021
Last Update
January 18 2022
Active Locations (3)
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1
Garuda Primary Health Centre
Bandung, West Java, Indonesia
2
Ibrahim Adjie Primary Health Centre
Bandung, West Java, Indonesia
3
Puter Primary Health Care
Bandung, West Java, Indonesia