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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05037227

Enrollment

1100

Registered

2021-09-08

Start date

2021-09-02

Completion date

2021-12-27

Last updated

2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety Issues

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Indonesia

Outcome results