N/A
Completed N=260
A Study to Understand is the COVID-19 Vaccine BNT162b2 is Safe in Indonesia People
Source: ClinicalTrials.gov NCT05621239 ↗Enrolled (actual)
260
Serious AEs
8.1%
Results posted
May 2025
Primary outcomePrimary: Number of Participants With Serious Adverse Events (SAEs) After Primary Dose — 16 Participants
Summary
The purpose of this study is to characterize descriptively the BNT162b2 vaccination safety experience among the Indonesian people. We will look at adverse events (AEs) reported in Indonesia Vaccine Safety Website for people 12 years of age and older. AEs are unwanted reactions associated with the use of the BNT162b2 vaccine. They may or may not be caused by this vaccine.
The secondary data collection will be exclusively from the Indonesia Vaccine Safety Website as requested by BPOM. This study does not seek additional participants. We will look at reported AEs for BNT162b2 vaccine since it became available in Indonesia. Individual data will be de-identified first before use. This will help protect personal information.
We will study the AEs associated with the BNT162b2 vaccine in several ways. These include the type of AEs and which body parts affected, among others. This will help us understand it the vaccine is safe in Indonesian people.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) After Primary Dose |
16 | — |
| PRIMARY Number of Participants With SAEs After Booster Dose |
5 | — |
| PRIMARY Number of Participants With Non Serious Adverse Events (Non SAEs) After Primary Dose |
134 | — |
| PRIMARY Number of Participants With Non SAEs After Booster Dose |
105 | — |
| SECONDARY Number of SAEs Reported According to Time of Onset |
7; 3; 5; 2; 5; 2 | — |
| SECONDARY Number of Participants According to Causality of SAEs |
12; 3; 0; 1; 2; 0 | — |
| SECONDARY Number of Participants According to Type of AEs |
21; 239 | — |
| SECONDARY Number of AEs Reported According to Solicited and Unsolicited AEs |
359; 154 | — |
| SECONDARY Number and Type of Solicited AEs Reported |
48; 24; 7; 113; 51; 43 | — |
| SECONDARY Number and Type of Unsolicited AEs Reported |
10; 5; 3; 44; 9; 9 | — |
Eligibility Criteria
Inclusion Criteria
This study will include adverse events reported in Indonesia Vaccine Safety Website for individuals 12 years of age and older
Exclusion Criteria
None
Data sourced from ClinicalTrials.gov (NCT05621239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.