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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PT Bio Farma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Advisory Immunization Committee Indonesia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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