A Phase I/II, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Populations Aged 18 Years and Above in Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Fakultas Kedokteran Universitas Indonesia, Badan Penelitian dan Pengembangan Kesehatan, Kementrian Kesehatan RI
No Registry
INA-ZTGW21
Tanggal Input Registry : 07-12-2021

13-12-2021
Number and percentage of subjects with solicited and unsolicited adverse events
Local reaction and systemic events occurring within 28 days after each immunization
 
A Phase I/II, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Populations Aged 18 Years and Above in Indonesia
A Phase I/II, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Populations Aged 18 Years and Above in Indonesia
Interventional
SARS-COV-2 protein recombinant vaccine
60
 

Inclusion Criteria:

Clinically healthy subjects within the following age groups: adults (18-59 years) and elderly (60 years and above, Subjects have been informed properly regarding the study and signed the informed consent form, Subjects 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 investigational product against COVID-19 during or 6 months prior to enrollment., Subjects who had history of COVID-19 in the last 3 months (based on anamnesis or other examinations)., Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun)., The result of rapid antigen test was positive., Women who were lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results)., Abnormality hematology and biochemical test results., 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., Subjects plan to move from the study area before the end of study period.
 
845/UN2.F1/ETIK/PPM.00.02/2021
Not applicable
PPUK/PPUB number
COV2-010221
Prof. Dr. dr. Rini Sekartini , SpA(K)