Safety Clinical Trial
Official title:
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
Verified date | January 2022 |
Source | PT Bio Farma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
PT Bio Farma |
Indonesia,
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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