A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
Fakultas Kedokteran Universitas Padjadjaran/RS Hasan Sadikin, Balitbangkes, Sinovac Life Sciences
No Registry
INA-WXFM0YX
Tanggal Input Registry : 07-08-2020

10-08-2020
- To evaluate the efficacy of SARS-CoV-2 vaccine in preventing disease caused by SARS-CoV-2
- To evaluate the efficacy of SARS-CoV-2 vaccine in preventing suspected cases. - To evaluate the safety of the SARS-CoV-2 vaccine. - To evaluate the immunogenicity of the SARS-CoV-2 vaccine - To evaluate lot-to-lot consistency using 3 batches of SARS-CoV-2 vaccine by assessment of serum immune response
 
A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia
A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia
Eksperimental
Investigational product: SARS-CoV-2 vaccine (inactivated) Control product: placebo
1620
 

Inclusion Criteria:

1. Clinically healthy adults aged 18 – 59 years. 2. Negative IgG and IgM for SARS-CoV-2 (by standardize rapid test). 3. Subjects have been informed properly regarding the study and signed the informed consent form. 4. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial. 2. Contact with novel coronavirus infected persons (positive for nucleic acid detection) within 14 days prior to the trial. 3. Contact to patients with fever or respiratory symptoms surrounding areas or from communities with reported cases within 14 days prior to the trial. 4. Two or more cases of fever and/or respiratory symptoms in a small area such as home, office, school and class within 14 days prior to the trial. 5. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). 6. Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). 7. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. 8. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. 9. 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. 10. 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 immuneresponse (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)). 11. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome 12. Subjects receive any vaccination within 1 month before and after IP immunization. 13. Subjects plan to move from the study area before the end of study period
 
669/UN6.KEP/EC/2020
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RG.01.06.1.3.07.20.09
CoV2-0320
Prof. Dr. Kusnandi Rusmil, dr., Sp.A(K)., MM