Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-18

Study Completion Date

2024-06-07

Brief Summary

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

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Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IndoVac COVID-19 Vaccine

Clinically healthy adults aged 18 years and above who received Booster IndoVac COVID-19 Vaccination

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hindra Irawan Satari, Prof., Dr., dr., SpA(K), M. Trop. Paed

Role: PRINCIPAL_INVESTIGATOR

National Committee of Adverse Events Following Immunization / NC Indonesia

Locations

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Gambir Public Health Center

Jakarta, Center Jakarta, Indonesia

Site Status

Kemayoran Public Health Center

Jakarta, Center Jakarta, Indonesia

Site Status

Menteng Public Health Center

Jakarta, Center Jakarta, Indonesia

Site Status

Sawah Besar Public Health Center

Jakarta, Center Jakarta, Indonesia

Site Status