A Study to Understand is the COVID-19 Vaccine BNT162b2 is Safe in Indonesia People
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05621239|
Recruitment Status : Active, not recruiting
First Posted : November 17, 2022
Last Update Posted : June 5, 2023
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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.
|Condition or disease||Intervention/treatment|
|Study Type :||Observational|
|Estimated Enrollment :||1 participants|
|Official Title:||Safety Profile of BNT162b2 mRNA SARS-Cov-2 Vaccine in Indonesia: A National Passive Surveillance.|
|Actual Study Start Date :||March 15, 2023|
|Estimated Primary Completion Date :||June 19, 2023|
|Estimated Study Completion Date :||June 19, 2023|
COVID-19 mRNA vaccine
BNT162b2 half dose and full dose
- The proportion of participants reporting Serious Adverse Event (SAE) after primary vaccination as compared to booster dose [ Time Frame: 1 year ]
- Total number of Adverse Events (AE) reported after both primary and booster dose [ Time Frame: 1 year ]
- Onset of SAE less than or equal to 30 minutes [ Time Frame: 1 year ]Number of participants reporting SAE less than or equal to 30 minutes
- Onset of SAE more than 30 minutes [ Time Frame: 1 year ]Number of participants reporting SAE onset more than 30 minutes
- Participants categorized according to the World Health Organization (WHO) causality assessment of adverse events following immunization [ Time Frame: 1 year ]WHO causality assessment of adverse event following immunization include (coincidence, Immunization Stress Related Response, vaccine reaction, unclassifiable, or indeterminate)
- Number of participants reporting local solicited AEs [ Time Frame: 1 year ]Local reaction include pain, swelling, redness or thickness
- Number of participants reporting systemic solicited AEs [ Time Frame: 1 year ]Systemic reaction include fever, myalgia, malaise
- Number of participants reporting local unsolicited reactions [ Time Frame: 1 year ]Local reactions includes abscess, bleeding, etc.
- Number of participants reporting systemic unsolicited reaction [ Time Frame: 1 year ]Systemic reaction include headache, nausea, arthralgia, etc.
- Proportion of participants reporting serious AEs as compared to non serious AEs [ Time Frame: 1 year ]
- Number of participants reporting solicited AE compared to unsolicited AE [ Time Frame: 1 year ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||12 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
This study will include adverse events reported in Indonesia Vaccine Safety Website for individuals 12 years of age and older
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05621239
|Study Director:||Pfizer CT.gov Call Center||Pfizer|
|Other Study ID Numbers:||
|First Posted:||November 17, 2022 Key Record Dates|
|Last Update Posted:||June 5, 2023|
|Last Verified:||June 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases