Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination

PT Bio Farma1,208 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

1,208

Conditions

COVID-19

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (28)

Outcomes

Primary Outcomes

Serious adverse event following IndoVac booster vaccination

Any serious adverse event occurring from inclusion until 30 minutes after IndoVac booster vaccination

Time frame: until 30 minutes after each dose

Secondary Outcomes

0-7 Days Reactions

Number and percentage of any solicited and unsolicited local reaction and systemic events within 0-7 days after IndoVac booster vaccination.

Time frame: Within 0-7 Days after each dose

8-28 Days Reactions

Number and percentage of any solicited and unsolicited local reaction and systemic events within 8-28 days after IndoVac booster vaccination.

Time frame: Within 8-28 Days after each dose

28 Days Reactions

Number and percentage of any serious adverse event after IndoVac booster vaccination

Time frame: 28 Days after each dose

Data from ClinicalTrials.gov

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