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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05037227
• Other study ID #: COVID19-0421
• Status: Completed
• Start date: September 2, 2021
• Est. completion date: December 27, 2021

Study information

• Verified date: July 2022
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: December 27, 2021
• Est. primary completion date: October 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Safety Issues

Locations

Country	Name	City	State
Indonesia	Jakarta Provincial Ministry of Health	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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