Post Authorization Safety Study Moderna COVID-19 Primary Vaccine

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06006858

Enrollment

1284

Registered

2023-08-23

Start date

2022-11-03

Completion date

2023-03-31

Last updated

2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19, Moderna Vaccine, Safety Vaccine

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.

Interventions

BIOLOGICALModerna 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.

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
4-7 Days Reactions	4-7 Days after each dose	percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.
Immediate Reactions	30 minutes 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
8-28 Days Reactions	8-28 Days 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.

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026