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

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

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.

Status
Completed
Conditions
COVID-19
Interventions

Biological: 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.

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Indonesia
Locations

Gambir Public Health Center
Jakarta Pusat 6754874, Jakarta Special Capital Region 1642907, Indonesia

Johar Baru Public Health Center
Jakarta Pusat 6754874, Jakarta Special Capital Region 1642907, Indonesia

Cempaka Putih Public Health Center
Jakarta Pusat 6754874, Jakarta Special Capital Region 1642907, Indonesia

Kemayoran Public Health Center
Jakarta Pusat 6754874, Jakarta Special Capital Region 1642907, Indonesia

Palmerah Public Health Center
Jakarta 1642911, Indonesia

Kebon Jeruk Public Health Center
Jakarta 1642911, Indonesia

Cengkareng Public Health Center
Jakarta 1642911, Indonesia

Kebayoran Lama Public Health Center
Jakarta 1642911, Indonesia

Tebet Public Health Center
Jakarta 1642911, Indonesia

Setiabudi Public Health Center
Jakarta 1642911, Indonesia

Pulo Gadung Public Health Center
Jakarta 1642911, Indonesia

Duren Sawit Public Health Center
Jakarta 1642911, Indonesia

Regional Hospital Duren Sawit
Jakarta 1642911, Indonesia

Kramat Jati Public Health Center
Jakarta 1642911, Indonesia

Cilincing Public Health Center
Jakarta 1642911, Indonesia

Koja Public Health Center
Jakarta 1642911, Indonesia

Tanjung Priok Public Health Center
Jakarta 1642911, Indonesia

Pademangan Public Health Center
Jakarta 1642911, Indonesia

Investigators

Julitasari Sundoro, MD, Principal Investigator
National Advisory Immunization Committee

Sponsors / Collaborators
National Advisory Immunization Committee Indonesia
NCT Number
NCT06006858
Keywords
Covid-19
Moderna Vaccine
Safety Vaccine
MeSH Terms
COVID-19
2019-nCoV Vaccine mRNA-1273