Safety and Tuberculin Conversion Following BCG vaccine vial (Bio Farma) compared to Registered BCG vaccine (Bio Farma) in Indonesian Infants”
Tahapan Penelitian : Complete
Sponsor:
PT Biofarma
Mitra Pelaksana:
RS. Dr. Soetomo Surabaya
No Registry
INA-TH0Z9M
Tanggal Input Registry : 29-11-2021
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 01-12-2021 |
| Outcome Primer | To evaluate the safety of BCG Vaccine Vial (Bio Farma) |
| Outcome Skunder | Local reaction and systemic events occurring within 24 hours, 48 hours and 72 hours after vaccination. |
| Descriptive Information | |
| Judul Penelitian Popular | Safety and Tuberculin Conversion Following BCG vaccine vial (Bio Farma) compared to Registered BCG vaccine (Bio Farma) in Indonesian Infants” |
| Judul Penelitian Ilmiah | Safety and Tuberculin Conversion Following BCG vaccine vial (Bio Farma) compared to Registered BCG vaccine (Bio Farma) in Indonesian Infants” |
| Jenis Penelitian | Interventional |
| Intervensi | BCG Vaccine vial (Bio Farma) |
| Jumlah Subyek Penelitian | 220 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1.Healthy infant aged 0-1 month. 2.Infants 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 instructions 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.Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5 oC). 3.Suspected of allergy to any component of the vaccines. 4.Newborn suspected of congenital or acquired immunodeficiency. 5.Received or plans to receive any treatment likely to alter the immune response intravenous (immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)). 6.Received other vaccination with the exception of OPV and Hepatitis B vaccine. 7.Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. 8.Any skin disease such eczema generalisata other skin infection which makes difficult the assessment of the local reactions. 9.Mothers with HbsAg and HIV positive (by rapid test) 10.Parents planning to move from the study area before the end of study period. |
| Administrative Information | |
| Nomor Persetujuan Etik | 0285/KEPK/X/2021 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | BSBCG 0221 |
| Contact Person | Dr. Dominicus Husada, dr., SpA(K) |