Post Authorization Safety Study Moderna COVID-19 Primary Vaccine

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

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.

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

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Biological: Moderna COVID-19 Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Moderna COVID-19 Vaccine<br>Clinically healthy adults aged ≥ 18 years who received Primary Moderna COVID-19 Vaccine | Biological: Moderna COVID-19 Vaccine<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Moderna Vaccine, Safety Vaccine