Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination

November 13, 2024 updated by: PT Bio Farma

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1208

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Center Jakarta
      • Jakarta, Center Jakarta, Indonesia
        • Gambir Public Health Center
      • Jakarta, Center Jakarta, Indonesia
        • Kemayoran Public Health Center
      • Jakarta, Center Jakarta, Indonesia
        • Menteng Public Health Center
      • Jakarta, Center Jakarta, Indonesia
        • Sawah Besar Public Health Center
      • Jakarta, Center Jakarta, Indonesia
        • Tanah Abang Public Health Center
    • East Jakarta
      • Jakarta, East Jakarta, Indonesia
        • Cakung Public Health Center
      • Jakarta, East Jakarta, Indonesia
        • Cipayung Public Health Center
      • Jakarta, East Jakarta, Indonesia
        • Ciracas Public Health Center
      • Jakarta, East Jakarta, Indonesia
        • Makasar Public Health Center
      • Jakarta, East Jakarta, Indonesia
        • Matraman Public Health Center
      • Jakarta, East Jakarta, Indonesia
        • Pulogadung Public Health Center
    • North Jakarta
      • Jakarta, North Jakarta, Indonesia
        • Cilincing Public Health Center
      • Jakarta, North Jakarta, Indonesia
        • Kelapa Gading Public Health Center
      • Jakarta, North Jakarta, Indonesia
        • Koja Public Health Center
      • Jakarta, North Jakarta, Indonesia
        • Pademangan Public Health Center
    • South Jakarta
      • Jakarta, South Jakarta, Indonesia
        • Cilandak Public Health Center
      • Jakarta, South Jakarta, Indonesia
        • Jagakarsa Public Health Center
      • Jakarta, South Jakarta, Indonesia
        • Kebayoran Baru Public Health Center
      • Jakarta, South Jakarta, Indonesia
        • Mampang Public Health Center
      • Jakarta, South Jakarta, Indonesia
        • Pancoran Public Health Center
      • Jakarta, South Jakarta, Indonesia
        • Pesanggrahan Public Health Center
    • West Jakarta
      • Jakarta, West Jakarta, Indonesia
        • Cengkareng Public Health Center
      • Jakarta, West Jakarta, Indonesia
        • Grogol Petamburan Public Health Center
      • Jakarta, West Jakarta, Indonesia
        • Kalideres Public Health Center
      • Jakarta, West Jakarta, Indonesia
        • Kebon Jeruk Public Health Center
      • Jakarta, West Jakarta, Indonesia
        • Kembangan Public Health Center
      • Jakarta, West Jakarta, Indonesia
        • Palmerah Public Health Center
    • West Java
      • Bandung, West Java, Indonesia
        • Imunicare Bio Farma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy adults aged 18 years and above

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
0-7 Days Reactions
Time Frame: 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.
Within 0-7 Days after each dose
8-28 Days Reactions
Time Frame: 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.
Within 8-28 Days after each dose
28 Days Reactions
Time Frame: 28 Days after each dose
Number and percentage of any serious adverse event after IndoVac booster vaccination
28 Days after each dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT Bio Farma

Investigators

  • Principal Investigator: Hindra Irawan Satari, Prof., Dr., dr., SpA(K), M. Trop. Paed, National Committee of Adverse Events Following Immunization / NC Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2023

Primary Completion (Actual)

June 3, 2024

Study Completion (Actual)

June 7, 2024

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 15, 2024

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COV19REC-0423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe