A Randomized, Double-Blind, and Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant mRNA Vaccines (ABO1009-DP and ABO CoV.617.1) in Indonesian Subjects Aged 18 Years and Older Who Have Not Received SARS-CoV-2 Vaccines
Tahapan Penelitian : Complete
Sponsor:
PT Etana Biotechnologies Indonesia
Mitra Pelaksana:
PT Tigermed Consulting Indonesia
No Registry
INA-2ETBDZ8
Tanggal Input Registry : 19-07-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 01-01-2022 |
| Outcome Primer | not specified |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | A Randomized, Double-Blind, and Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant mRNA Vaccines (ABO1009-DP and ABO CoV.617.1) in Indonesian Subjects Aged 18 Years and Older Who Have Not Received SARS-CoV-2 Vaccines |
| Judul Penelitian Ilmiah | A Randomized, Double-Blind, and Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant mRNA Vaccines (ABO1009-DP and ABO CoV.617.1) in Indonesian Subjects Aged 18 Years and Older Who Have Not Received SARS-CoV-2 Vaccines |
| Jenis Penelitian | Interventional |
| Intervensi | SARS-CoV-2 Variant mRNA Vaccines (ABO1009-DP and ABO CoV.617.1) |
| Jumlah Subyek Penelitian | 5 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: not specifiedExclusion Criteria: not specified |
| Administrative Information | |
| Nomor Persetujuan Etik | not specified |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | |
| Contact Person | not specified |