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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04071379
Other study ID # Penta BS19
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 13, 2020
Est. completion date December 16, 2021

Study information

Verified date January 2022
Source PT Bio Farma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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 Infants


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date December 16, 2021
Est. primary completion date April 6, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 3 Days
Eligibility 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. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Indonesia Garuda Primary Health Centre Bandung West Java
Indonesia Ibrahim Adjie Primary Health Centre Bandung West Java
Indonesia Puter Primary Health Care Bandung West Java

Sponsors (1)

Lead Sponsor Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) with new Hepatitis B bulk Percentage of infants with anti-diphtheria titer and anti-tetanus titer > 0.01 IU/ml, anti HbsAg titer > 10 mIU/ml, and anti PRP-T titer > 0.15 ug/ml 28 days after the last injection of DTP/HB/Hib with different source of Hepatitis B bulk vaccine group. 28 days after immunization
Secondary Describes antibody response to diphtheria toxoid, tetanus toxoid in both group with the evaluation criteria Serological response to diphtheria toxoid, tetanus toxoid: GMT, percentage of infants with titer > 0.01 IU/ml, > 0.1 IU/ml percentage of infants with increasing antibody titer > 4 times and/or percentage of infants with transition of seronegative to seropositive 28 days after immunization
Secondary Serological response to the pertussis component (agglutinins) Serological response to the pertussis component (agglutinins): GMT, percentage of infants with titer > 40, > 80, > 160 and > 320 (1/dil.), percentage of infants with increasing antibody titer > 4 times 28 days after immunization
Secondary Geometric mean of anti-HbsAg Geometric mean of anti-HbsAg, percentage of infants with titer > 10mIU/ml, percentage of infants with increasing antibody titer > 4 times and/ or percentage of infants with transition of seronegative to seropositive 28 days after immunization
Secondary Serological response to Hib/PRP Serological response to Hib/PRP: GMT, percentage of infants with titer >1 ug /ml ; > 0.15 ug /ml percentage of infants with increasing antibody titer > 4 times and/or percentage of infants with transition of seronegative to seropositive 28 days after immunization
Secondary Seroconversion Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer > 4 times and/ or percentage of subjects with transition of seronegative to seropositive following primary series of investigational product compare to control. 28 days after immunization
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