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

NCT05037227 | Completed DMC

• 1 other identifier: COVID19-0421
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Local reaction and systemic events occurring within 30 minutes after each immunization.

  Within 30 minutes after vaccination

• Local reaction and systemic events occurring within 28 days after immunization

  28 days

• Any serious adverse event during observation period.

  28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study is involving healthy adults aged \> 18 years.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PT Bio Farma: lead

Study Sites (1)

Jakarta Provincial Ministry of Health

Jakarta, DKI Jakarta, Indonesia

Location

Study Officials

• Julitasari Sundoro, MD

  Indonesian Vaccine Safety Advisory Commitee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 8, 2021
• Study Start: September 2, 2021
• Primary Completion: October 17, 2021
• Study Completion: December 27, 2021
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

ID (1)