Post Authorization Safety Study Moderna COVID-19 Primary Vaccine

November 16, 2023 updated by: PT Bio Farma

Safety Profile Following Moderna COVID-19 Primary Vaccine in Healthy Adults Aged ≥ 18 Years in Indonesia

This study is Post Authorization Safety Study (PASS) Phase IV of Moderna COVID-19 Primary Vaccine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and systemic reaction after immunization with Moderna COVID-19 vaccine using retrospective cohort study trial design to assess safety profile following Moderna COVID-19 primary vaccine in healthy adults aged ≥ 18 years in Indonesia.

Study Type

Observational

Enrollment (Actual)

1284

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
      • Jakarta, Indonesia, 11480
        • Palmerah Public Health Center
      • Jakarta, Indonesia, 11530
        • Kebon Jeruk Public Health Center
      • Jakarta, Indonesia, 11730
        • Cengkareng Public Health Center
      • Jakarta, Indonesia, 12240
        • Kebayoran Lama Public Health Center
      • Jakarta, Indonesia, 12820
        • Tebet Public Health Center
      • Jakarta, Indonesia, 12980
        • Setiabudi Public Health Center
      • Jakarta, Indonesia, 13260
        • Pulo Gadung Public Health Center
      • Jakarta, Indonesia, 13420
        • Duren Sawit Public Health Center
      • Jakarta, Indonesia, 13440
        • Regional Hospital Duren Sawit
      • Jakarta, Indonesia, 13510
        • Kramat Jati Public Health Center
      • Jakarta, Indonesia, 14120
        • Cilincing Public Health Center
      • Jakarta, Indonesia, 14260
        • Koja Public Health Center
      • Jakarta, Indonesia, 14310
        • Tanjung Priok Public Health Center
      • Jakarta, Indonesia, 14410
        • Pademangan Public Health Center
    • Jakarta
      • Jakarta Pusat, Jakarta, Indonesia, 10130
        • Gambir Public Health Center
      • Jakarta Pusat, Jakarta, Indonesia, 10560
        • Johar Baru Public Health Center
      • Jakarta Pusat, Jakarta, Indonesia, 10570
        • Cempaka Putih Public Health Center
      • Jakarta Pusat, Jakarta, Indonesia, 10640
        • Kemayoran Public Health Center

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

Description

Inclusion Criteria:

  • Clinically healthy adults aged ≥ 18 years.
  • Subjects have been informed properly regarding the study and accepted to be enrolled in this study.

Exclusion Criteria:

- Subjects concomitantly enrolled or scheduled to be enrolled in another trial at the time of receiving the Moderna COVID-19 vaccine.

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
Intervention / Treatment
Moderna COVID-19 Vaccine
Clinically healthy adults aged ≥ 18 years who received Primary Moderna COVID-19 Vaccine
Biological: Moderna COVID-19 Vaccine
Moderna COVID-19 Vaccine is provided as a white to off-white suspension for intramuscular injection. Each 0.5 mL dose of Moderna COVID-19 Vaccine contains 100 mcg of nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Reactions Following Moderna COVID-19 Vaccine
Time Frame: 28 Days after each dose
Percentage of subject with local reactions following immunization with Moderna COVID-19 vaccine.
28 Days after each dose
Systemic Reactions Following Moderna COVID-19 Vaccine
Time Frame: 28 Days after each dose
Percentage of subject with systemic reactions following immunization with Moderna COVID-19
28 Days after each dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate Reactions
Time Frame: 30 minutes after each dose
percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.
30 minutes after each dose
1-3 Days Reactions
Time Frame: 1-3 minutes after each dose
percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.
1-3 minutes after each dose
4-7 Days Reactions
Time Frame: 4-7 Days after each dose
percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.
4-7 Days after each dose
8-28 Days Reactions
Time Frame: 8-28 Days after each dose
percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.
8-28 Days after each dose
Serious Reactions
Time Frame: 28 Days after each dose
Any serious adverse events following immunization with Moderna COVID-19 vaccine
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

Collaborators

National Advisory Immunization Committee Indonesia

Investigators

  • Principal Investigator: Julitasari Sundoro, MD, National Advisory Immunization Committee

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)

November 3, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COV19M-0422

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.

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