Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination

Safety Profile of Booster IndoVac COVID-19 Vaccination in Healthy Populations Aged 18 Years and Above

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06690502

Enrollment

1208

Registered

2024-11-15

Start date

2023-12-18

Completion date

2024-06-07

Last updated

2024-11-15

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

Conditions

COVID-19

Keywords

COVID-19, IndoVac, Safety Vaccine

Brief summary

This study is Post Authorization Safety Study (PASS) Phase IV of Booster IndoVac COVID-19 Vaccination

Detailed description

This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and systemic reaction after immunization with IndoVac using retrospective cohort study trial design to assess safety profile following IndoVac booster vaccine in healthy populations aged 18 years and above.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Clinically healthy subjects aged 18 years and above 2. Subjects have been injected with IndoVac booster. 3. Minimum 6-month interval from primary or booster COVID-19 vaccination. 4. Subjects have been informed properly regarding the study and signed the informed consent form.

Exclusion criteria

1. Subjects concomitantly enrolled or scheduled to be enrolled in another study when the subjects got IndoVac booster vaccination. 2. Subject's telephone number is invalid or cannot be contacted.

Design outcomes

Primary

Measure	Time frame	Description
Serious adverse event following IndoVac booster vaccination	until 30 minutes after each dose	Any serious adverse event occurring from inclusion until 30 minutes after IndoVac booster vaccination

Secondary

Measure	Time frame	Description
0-7 Days Reactions	Within 0-7 Days after each dose	Number and percentage of any solicited and unsolicited local reaction and systemic events within 0-7 days after IndoVac booster vaccination.
8-28 Days Reactions	Within 8-28 Days after each dose	Number and percentage of any solicited and unsolicited local reaction and systemic events within 8-28 days after IndoVac booster vaccination.
28 Days Reactions	28 Days after each dose	Number and percentage of any serious adverse event after IndoVac booster vaccination

Countries

Indonesia

Outcome results