Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
NCT ID: NCT05037227
Last Updated: 2022-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1100 participants
OBSERVATIONAL
2021-09-02
2021-12-27
Brief Summary
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Detailed Description
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To assess systemic reaction after COVID-19 Vaccine immunization. To assess local reaction after COVID-19 Vaccine immunization. To assess any serious adverse event after COVID-19 Vaccine immunization.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with thermometer).
* Women who are lactating, pregnant or planning to become pregnant during the study period.
* History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
* 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 receive any vaccination within 1 month before and after IP immunization.
* Subjects plan to move from the study area before the end of study period.
18 Years
ALL
Yes
Sponsors
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PT Bio Farma
INDUSTRY
Responsible Party
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Principal Investigators
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Julitasari Sundoro, MD
Role: PRINCIPAL_INVESTIGATOR
Indonesian Vaccine Safety Advisory Commitee
Locations
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Jakarta Provincial Ministry of Health
Jakarta, DKI Jakarta, Indonesia
Countries
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Other Identifiers
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COVID19-0421
Identifier Type: -
Identifier Source: org_study_id
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