Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia

Completed

• Conditions: Safety Issues

• Registration Number: NCT05037227
• Lead Sponsor: PT Bio Farma

Brief Summary

The aim of this study is evaluating safety profile of COVID-19 Vaccine in healthy adults aged \>18 years in Indonesia.

Detailed Description

To assess any serious systemic reaction within 30 minutes after COVID-19 vaccine immunization.

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.

Study Timeline

• Study Start: 2021-09-02
• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-06
• Study First Posted: 2021-09-08
• Primary Completion: 2021-10-17
• Study Completion: 2021-12-27
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• Clinically healthy adults aged > 18 years.
• 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

• Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any serious adverse event occurring from inclusion until 30 minutes after the injection	Within 30 minutes after vaccination	Number and percentage of subjects with serious systemic reactions 30 minutes after immunization.

Secondary Outcome Measures

Name	Time	Method
Local reaction and systemic events occurring within 30 minutes after each immunization.	Within 30 minutes after vaccination	Number and percentage of subjects with at least one of these adverse events, solicited or not, within 30 minutes after vaccination.
Local reaction and systemic events occurring within 28 days after immunization	28 days	Number and percentage of subjects with at least one of these adverse events, solicited or not, within 28 days after vaccination.
Any serious adverse event during observation period.	28 days	Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination.

Trial Locations

Locations (1)

Jakarta Provincial Ministry of Health; 🇮🇩 Jakarta, DKI Jakarta, Indonesia