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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05621239
• Other study ID #: C4591050
• Status: Completed
• Start date: March 15, 2023
• Est. completion date: April 3, 2023

Study information

• Verified date: August 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: April 3, 2023
• Est. primary completion date: April 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• BNT162b2
BNT162b2 half dose and full dose

Locations

Country	Name	City	State
Indonesia	Pfizer	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of participants reporting Serious Adverse Event (SAE) after primary vaccination as compared to booster dose		1 year
Primary	Total number of Adverse Events (AE) reported after both primary and booster dose		1 year
Secondary	Onset of SAE less than or equal to 30 minutes	Number of participants reporting SAE less than or equal to 30 minutes	1 year
Secondary	Onset of SAE more than 30 minutes	Number of participants reporting SAE onset more than 30 minutes	1 year
Secondary	Participants categorized according to the World Health Organization (WHO) causality assessment of adverse events following immunization	WHO causality assessment of adverse event following immunization include (coincidence, Immunization Stress Related Response, vaccine reaction, unclassifiable, or indeterminate)	1 year
Secondary	Number of participants reporting local solicited AEs	Local reaction include pain, swelling, redness or thickness	1 year
Secondary	Number of participants reporting systemic solicited AEs	Systemic reaction include fever, myalgia, malaise	1 year
Secondary	Number of participants reporting local unsolicited reactions	Local reactions includes abscess, bleeding, etc.	1 year
Secondary	Number of participants reporting systemic unsolicited reaction	Systemic reaction include headache, nausea, arthralgia, etc.	1 year
Secondary	Proportion of participants reporting serious AEs as compared to non serious AEs		1 year
Secondary	Number of participants reporting solicited AE compared to unsolicited AE		1 year

External Links

•   To obtain contact information for a study center near you, click here.