Trials / Completed
CompletedNCT06006858
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,284 (actual)
- Sponsor
- PT Bio Farma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-11-03
- Primary completion
- 2022-12-31
- Completion
- 2023-03-31
- First posted
- 2023-08-23
- Last updated
- 2023-11-18
Locations
18 sites across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT06006858. Inclusion in this directory is not an endorsement.