A Phase III, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Aged 12-17 Years in Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT Bio Farma (Persero)
Mitra Pelaksana:
Fakultas Kedokteran Universitas Gajah Mada, Fakultas Kedokteran Universitas Indonesia, Fakultas Kedokteran Universitas Andalas, PT Equilab International (CRO)
No Registry
INA-FFO44FZ
Tanggal Input Registry : 03-10-2022
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 09-10-2022 |
| Outcome Primer | To evaluate immunogenic non-inferiority immune response of SARS-CoV-2 neutralizing antibody of Bio Farma vaccine compared to vaccine control at 14 days after primary series. |
| Outcome Skunder | Seropositive rate of neutralizing antibody at baseline, 14 days, 3, 6 and 12 months after primary series vaccination. |
| Descriptive Information | |
| Judul Penelitian Popular | A Phase III, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Aged 12-17 Years in Indonesia |
| Judul Penelitian Ilmiah | A Phase III, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Aged 12-17 Years in Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | IndoVac, SARS-CoV-2 subunit protein recombinant vaccine |
| Jumlah Subyek Penelitian | 1050 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Clinically healthy children aged 12-17 years, Parent/legal guardian and subject has been informed properly regarding the study, and signed the informed consent form (parent/legal guardian) and assent form (subject), Parent/legal guardian and subject will commit to comply with the instructions of the investigator and the schedule of the trial.Exclusion Criteria: Subjects concomitantly enrolled or scheduled to be enrolled in another trial, History of vaccination with any COVID-19 vaccine (based on anamnesis), History of COVID-19 within 3 months prior to enrollment (based on anamnesis), Evolving mild moderate or severe illness especially infectious disease or fever (body temperature ≥37.5℃ measured with infrared thermometer/thermal gun), History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema, History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives, Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)), Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome, Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization, Female who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results), Subjects plan to move from the study area before the end of study period. |
| Administrative Information | |
| Nomor Persetujuan Etik | KE/FK/1109/EC2022, 897/UN.16.2/KEPK-FK/2022, KET-992/UN2.F1/ETIK/ PPM.00.02/2022 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | CoV2-Children-0322 |
| Contact Person | dr. Cahya Dewi Satria, M.Kes., Sp.A(K) |