Post Authorization Safety Study Moderna COVID-19 Primary Vaccine

NCT ID: NCT06006858

Last Updated: 2023-11-18

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

1284 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-03

Study Completion Date

2023-03-31

Brief Summary

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

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 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.

Conditions

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COVID-19

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Moderna COVID-19 Vaccine

Clinically healthy adults aged ≥ 18 years who received Primary Moderna COVID-19 Vaccine

Moderna COVID-19 Vaccine

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Advisory Immunization Committee Indonesia

UNKNOWN

Sponsor Role collaborator

PT Bio Farma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julitasari Sundoro, MD

Role: PRINCIPAL_INVESTIGATOR

National Advisory Immunization Committee

Locations

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Gambir Public Health Center

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status

Johar Baru Public Health Center

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status

Cempaka Putih Public Health Center

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status

Kemayoran Public Health Center

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status

Palmerah Public Health Center

Jakarta, , Indonesia

Site Status

Kebon Jeruk Public Health Center

Jakarta, , Indonesia

Site Status

Cengkareng Public Health Center

Jakarta, , Indonesia

Site Status

Kebayoran Lama Public Health Center

Jakarta, , Indonesia

Site Status

Tebet Public Health Center

Jakarta, , Indonesia

Site Status

Setiabudi Public Health Center

Jakarta, , Indonesia

Site Status

Pulo Gadung Public Health Center

Jakarta, , Indonesia

Site Status

Duren Sawit Public Health Center

Jakarta, , Indonesia

Site Status

Regional Hospital Duren Sawit

Jakarta, , Indonesia

Site Status

Kramat Jati Public Health Center

Jakarta, , Indonesia

Site Status

Cilincing Public Health Center

Jakarta, , Indonesia

Site Status

Koja Public Health Center

Jakarta, , Indonesia

Site Status

Tanjung Priok Public Health Center

Jakarta, , Indonesia

Site Status

Pademangan Public Health Center

Jakarta, , Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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COV19M-0422

Identifier Type: -

Identifier Source: org_study_id

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