Post Authorization Safety Study Moderna COVID-19 Primary Vaccine

PT Bio Farma1,284 enrolled

Overview

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

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

1,284

Conditions

COVID-19

Interventions

Moderna COVID-19 VaccineBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (18)

Gambir Public Health Center

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Johar Baru Public Health Center

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Outcomes

Primary Outcomes

Local Reactions Following Moderna COVID-19 Vaccine

Percentage of subject with local reactions following immunization with Moderna COVID-19 vaccine.

Time frame: 28 Days after each dose

Systemic Reactions Following Moderna COVID-19 Vaccine

Percentage of subject with systemic reactions following immunization with Moderna COVID-19

Time frame: 28 Days after each dose

Secondary Outcomes

Immediate Reactions

percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.

Time frame: 30 minutes after each dose

1-3 Days Reactions

percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.

Time frame: 1-3 minutes after each dose

4-7 Days Reactions

percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.

Time frame: 4-7 Days after each dose

8-28 Days Reactions

percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.

Time frame: 8-28 Days after each dose

Serious Reactions

Any serious adverse events following immunization with Moderna COVID-19 vaccine

Time frame: 28 Days after each dose

Data from ClinicalTrials.gov

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