Clinical trial NCT05621239: A Study to Understand is the COVID-19 Vaccine BNT162b2 is Safe in Indonesia People
Official title: Safety Profile of BNT162b2 mRNA SARS-Cov-2 Vaccine in Indonesia: A National Passive Surveillance.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Indonesia
Vaccine
BNT162b2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-11-17
Enrollment: 260
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people in Indonesia above 12 years of age who received vaccine and report an adverse event

Brief 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.


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

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs) After Primary Dose
timeFrame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
measure: Number of Participants With SAEs After Booster Dose
timeFrame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
measure: Number of Participants With Non Serious Adverse Events (Non SAEs) After Primary Dose
timeFrame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
measure: Number of Participants With Non SAEs After Booster Dose
timeFrame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
Secondary outcomes:
measure: Number of SAEs Reported According to Time of Onset
timeFrame: Within 30min and>30min after vacc., secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days)included AEs reported following administration vacc. from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
measure: Number of Participants According to Causality of SAEs
timeFrame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
measure: Number of Participants According to Type of AEs
timeFrame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
measure: Number of AEs Reported According to Solicited and Unsolicited AEs
timeFrame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
measure: Number and Type of Solicited AEs Reported
timeFrame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
measure: Number and Type of Unsolicited AEs Reported
timeFrame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: