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Clinical trial

Safety Profile Following Moderna COVID-19 Primary Vaccine in Healthy Adults Aged ≥ 18 Years in Indonesia

ID
Name
COV19M-0422
Description
This study is Post Authorization Safety Study (PASS) Phase IV of Moderna COVID-19 Primary Vaccine
Trial arms
Trial start
2022-11-03
Estimated PCD
2022-12-31
Trial end
2023-03-31
Status
Completed
Treatment
Moderna COVID-19 Vaccine
Moderna COVID-19 Vaccine is provided as a white to off-white suspension for intramuscular injection. Each 0.5 mL dose of Moderna COVID-19 Vaccine contains 100 mcg of nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus.
Arms:
Moderna COVID-19 Vaccine
Size
1284
Primary endpoint
Local Reactions Following Moderna COVID-19 Vaccine
28 Days after each dose
Systemic Reactions Following Moderna COVID-19 Vaccine
28 Days after each dose
Eligibility criteria
Inclusion Criteria: * Clinically healthy adults aged ≥ 18 years. * Subjects have been informed properly regarding the study and accepted to be enrolled in this study. Exclusion Criteria: - Subjects concomitantly enrolled or scheduled to be enrolled in another trial at the time of receiving the Moderna COVID-19 vaccine.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 1284, 'type': 'ACTUAL'}}
Updated at
2023-11-18

1 organization

1 product

1 indication

Organization
PT Bio Farma
Product
Moderna COVID-19 Vaccine
Indication
COVID-19