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

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

Study Overview

• Status: Completed
• Conditions: Safety Issues

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 Type: Observational
• Enrollment (Actual): 1100

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia
      • Jakarta Provincial Ministry of Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study is involving healthy adults aged > 18 years.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: PT Bio Farma

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Actual): October 17, 2021
• Study Completion (Actual): December 27, 2021

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 6, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: COVID19-0421

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No