Phase
Condition
Covid-19
Treatment
SARS-CoV-2 subunit protein recombinant vaccine
Active Comparator
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Clinically healthy adults 18 years of age and older.
Subjects who have previously received complete primary series of authorized/approvedinactivated (Sinovac®), mRNA (Pfizer®), or viral vector COVID-19 vaccine (AstraZeneca®) with the last dose administered a minimum of 6 months prior toinclusion but not longer than 12 months prior to inclusion.
Subjects have been informed properly regarding the study and signed the informedconsent form.
Subjects will commit to comply with the instructions of the investigator and theschedule of the trial.
Exclusion
Exclusion Criteria:
Subject concomitantly enrolled or scheduled to be enrolled in another trial.
Subject who has received booster dose of COVID-19 vaccine.
Subject who has history of COVID-19 in the last 3 months (based on anamnesis orother examinations).
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 asthma, history of allergy to vaccines or vaccine ingredients, and severeadverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
History of uncontrolled coagulopathy or blood disorders contraindicatingintramuscular 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 thetrial objectives.
Subjects who have any history of confirmed or suspected immunosuppressive orimmunodeficient state, or received in the previous 4 weeks a treatment likely toalter the immune response (intravenous immunoglobulins, blood-derived products orlong-term corticosteroid therapy (> 2 weeks)).
Subjects who have history of uncontrolled epilepsy or other progressive neurologicaldisorders, such as Guillain-Barre Syndrome.
Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month beforeand after IP immunization.
Subjects plan to move from the study area before the end of study period.
Study Design
Study Description
Connect with a study center
Faculty of Medicine Universitas Udayana
Denpasar, Bali
IndonesiaSite Not Available
Faculty of Medicine Universitas Padjadjaran
Bandung, West Java
IndonesiaSite Not Available
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