A Study to Understand is the COVID-19 Vaccine BNT162b2 is Safe in Indonesia People
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| COMIRNATY COVID-19 mRNA vaccine |
Biological: BNT162b2
BNT162b2 half dose and full dose
|
Outcome Measures
Primary Outcome Measures
- The proportion of participants reporting Serious Adverse Event (SAE) after primary vaccination as compared to booster dose [1 year]
- Total number of Adverse Events (AE) reported after both primary and booster dose [1 year]
Secondary Outcome Measures
- Onset of SAE less than or equal to 30 minutes [1 year]
Number of participants reporting SAE less than or equal to 30 minutes
- Onset of SAE more than 30 minutes [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 [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 [1 year]
Local reaction include pain, swelling, redness or thickness
- Number of participants reporting systemic solicited AEs [1 year]
Systemic reaction include fever, myalgia, malaise
- Number of participants reporting local unsolicited reactions [1 year]
Local reactions includes abscess, bleeding, etc.
- Number of participants reporting systemic unsolicited reaction [1 year]
Systemic reaction include headache, nausea, arthralgia, etc.
- Proportion of participants reporting serious AEs as compared to non serious AEs [1 year]
- Number of participants reporting solicited AE compared to unsolicited AE [1 year]
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C4591050