Post Authorization Safety Study Moderna COVID-19 Primary Vaccine

PT Bio Farma

Status: Completed

Conditions: COVID-19

Treatments: Biological: Moderna COVID-19 Vaccine

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06006858

COV19M-0422

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,284 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,284 participants in 1 patient group

Moderna COVID-19 Vaccine

Description:

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

Treatment:

Biological: Moderna COVID-19 Vaccine