Status:
COMPLETED
Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine
Lead Sponsor:
PT Bio Farma
Collaborating Sponsors:
Fakultas Kedokteran Universitas Indonesia
Faculty of Medicine Universitas Diponegoro
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Observer-blind, randomized, active-controlled prospective intervention study
Detailed Description
This trial is randomized, prospective intervention study. A total of 4,050 subjects (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved i...
Eligibility Criteria
Inclusion
- Clinically healthy subjects aged 18 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
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- History of vaccination with any COVID-19 vaccine.
- History of COVID-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment.
- Evolving mild, moderate, or severe illness, especially infectious disease, or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
- Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
- History of uncontrolled asthma, allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
- History of 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.
- History of confirmed or suspected immunosuppressive or immunodeficient state or in the previous 4 weeks received a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or long-term corticosteroid therapy (\> 2 weeks)).
- 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.
Key Trial Info
Start Date :
June 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
4050 Patients enrolled
Trial Details
Trial ID
NCT05433285
Start Date
June 7 2022
End Date
August 31 2023
Last Update
November 29 2023
Active Locations (4)
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1
Faculty of Medicine Diponegoro University
Semarang, Central Java, Indonesia
2
Fakultas Kedokteran Universitas Indonesia
Jakarta, Greater Jakarta, Indonesia
3
Faculty of Medicine Universitas Hassanudin
Makassar, South Sulawesi, Indonesia
4
Faculty of Medicine Universitas Andalas
Padang, West Sumatera, Indonesia