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

Pfizer logo

Pfizer

Status

Completed

Conditions

COVID-19

Treatments

Biological: BNT162b2

Study type

Observational

Funder types

Industry

Identifiers

NCT05621239
NCT05621239 (Registry Identifier)
C4591050

Details and patient eligibility

About

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.

Enrollment

260 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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

Trial design

260 participants in 1 patient group

COMIRNATY
Description:
COVID-19 mRNA vaccine
Treatment:
Biological: BNT162b2

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Pfizer CT.gov Call Center

Data sourced from clinicaltrials.gov

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