Safety Profile of BCG vaccine vial (Bio Farma)
Tahapan Penelitian : Initial
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 | - To assess the local and systemic reactions within 30 minutes, 24 hours, 48 hours, 72 hours, 7 days and 30 days after vaccination. - To assess local reactions at 60 days and 90 days after vaccination in each group. - To assess serious adverse events within 30 days after vaccinantion in each group. - To assess the tuberculin conversion in each group. |
| Descriptive Information | |
| Judul Penelitian Popular | Safety Profile of BCG vaccine vial (Bio Farma) |
| 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 | This trial is bridging study, observer blinded, comparative, randomized study. Approximately 220 subjects will be recruited, 110 subjects are the investigational arm (BCG vaccine vial) and 110 subjects are the active comparator arm (BCG vaccine ampoule). |
| 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 | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | BSBCG 0221 |
| Contact Person | Dr. Dominicus Husada, dr., SpA(K) |