NCT05621239

A Study to Understand is the COVID-19 Vaccine BNT162b2 is Safe in Indonesia People

Safety Profile of BNT162b2 mRNA SARS-Cov-2 Vaccine in Indonesia: A National Passive Surveillance.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 260 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2	BNT162b2 half dose and full dose

Timeline

• Start date: 2023-03-15
• Primary completion: 2023-04-03
• Completion: 2023-04-03
• First posted: 2022-11-17
• Last updated: 2025-05-20
• Results posted: 2025-05-20

Locations

1 site across 1 country: Indonesia

Regulatory

• FDA-regulated drug study