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
Tahapan Penelitian : Initial
Sponsor:
PT. Bio Farma
Mitra Pelaksana:
Departemen Ilmu Kesehatan Anak RS Hasan Sadikin/Fakultas Kedokteran Universitas Padjadjaran, Bandung
No Registry
INA-KGMRF0T
Tanggal Input Registry : 15-04-2020
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 01-05-2020 |
| Outcome Primer | To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using different source of Hepatitis B bulk |
| Outcome Skunder | - To describe the antibody response to diphtheria, pertussis, tetanus, hepatitis B and PRP-TT when the antigens are presented in the form of DTP-HB-Hib liquid vaccine using different source of Hepatitis B bulk. - To describe the antibody response to diphtheria, pertussis, tetanus, hepatitis B and PRP-TT in Pentabio® vaccine. - To assess the safety of DTP-HB-Hib using different source of Hepatitis B bulk. - To assess the safety of Recombinant Hepatitis B using different source of Hepatitis B bulk at birth dose. - To evaluate immunogenicity and safety after primary series of investigational product compare to control. |
| Descriptive Information | |
| Judul Penelitian Popular | 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 |
| Judul Penelitian Ilmiah | 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 |
| Jenis Penelitian | Observasional |
| Intervensi | Investigational product: DTP-HB-Hib Vaccine (Bio Farma) using different source of Hepatitis B bulk and Recombinant Hepatitis B (Bio Farma) using different source bulk Control Product: Pentabio Vaccine® (Bio Farma) and Recombinant Hepatitis B® vaccine (Bio Farma) |
| Jumlah Subyek Penelitian | 220 |
| Recruitment Information | |
| Eligibility Criteria | 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 37.5C 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 ) 10. Mother suspected of immunodeficiency disease based on anamnesis |
| Administrative Information | |
| Nomor Persetujuan Etik | 30/UN6.KEP/EC/2020 |
| Nomor Persetujuan Material Transfer Agreement | N.A |
| Nomor Persetujuan Pelaksanaan Uji Klinik | R-RG.01.06.32.321.04.20.313 |
| Other Study ID Numbers | Penta BS19 |
| Contact Person | Dr. Eddy Fadlyana, dr.,Sp.A(K).,MKes |