Status:
COMPLETED
Post Authorization Safety Study Moderna COVID-19 Primary Vaccine
Lead Sponsor:
PT Bio Farma
Collaborating Sponsors:
National Advisory Immunization Committee Indonesia
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Brief Summary
This study is Post Authorization Safety Study (PASS) Phase IV of Moderna COVID-19 Primary Vaccine
Detailed Description
This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and systemic reaction after immunization with Moderna COVID-19 vaccine using retrospective cohort study trial design ...
Eligibility Criteria
Inclusion
- Clinically healthy adults aged ≥ 18 years.
- Subjects have been informed properly regarding the study and accepted to be enrolled in this study.
Exclusion
- \- Subjects concomitantly enrolled or scheduled to be enrolled in another trial at the time of receiving the Moderna COVID-19 vaccine.
Key Trial Info
Start Date :
November 3 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
1284 Patients enrolled
Trial Details
Trial ID
NCT06006858
Start Date
November 3 2022
End Date
March 31 2023
Last Update
November 18 2023
Active Locations (18)
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1
Gambir Public Health Center
Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10130
2
Johar Baru Public Health Center
Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10560
3
Cempaka Putih Public Health Center
Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10570
4
Kemayoran Public Health Center
Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10640