Post Authorization Safety Study Moderna COVID-19 Primary Vaccine

Completed

• Conditions: COVID-19
• Interventions: Biological: Moderna COVID-19 Vaccine

• Registration Number: NCT06006858
• Lead Sponsor: PT Bio Farma

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.

Study Timeline

• Study Start: 2022-11-03
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31
• Study First Submitted: 2023-08-22
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1284

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Local Reactions Following Moderna COVID-19 Vaccine	28 Days after each dose	Percentage of subject with local reactions following immunization with Moderna COVID-19 vaccine.
Systemic Reactions Following Moderna COVID-19 Vaccine	28 Days after each dose	Percentage of subject with systemic reactions following immunization with Moderna COVID-19

Secondary Outcome Measures

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

Trial Locations

Locations (18)

Cengkareng Public Health Center; 🇮🇩 Jakarta, Indonesia

Kebon Jeruk Public Health Center; 🇮🇩 Jakarta, Indonesia

Tebet Public Health Center; 🇮🇩 Jakarta, Indonesia

Regional Hospital Duren Sawit; 🇮🇩 Jakarta, Indonesia

Kramat Jati Public Health Center; 🇮🇩 Jakarta, Indonesia

Cilincing Public Health Center; 🇮🇩 Jakarta, Indonesia

Kebayoran Lama Public Health Center; 🇮🇩 Jakarta, Indonesia

Setiabudi Public Health Center; 🇮🇩 Jakarta, Indonesia

Duren Sawit Public Health Center; 🇮🇩 Jakarta, Indonesia

Koja Public Health Center; 🇮🇩 Jakarta, Indonesia

Tanjung Priok Public Health Center; 🇮🇩 Jakarta, Indonesia

Pademangan Public Health Center; 🇮🇩 Jakarta, Indonesia

Palmerah Public Health Center; 🇮🇩 Jakarta, Indonesia

Johar Baru Public Health Center; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia

Cempaka Putih Public Health Center; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia

Kemayoran Public Health Center; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia

Gambir Public Health Center; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia

Pulo Gadung Public Health Center; 🇮🇩 Jakarta, Indonesia