A Study to Understand is the COVID-19 Vaccine BNT162b2 is Safe in Indonesia People
NCT ID: NCT05621239
Last Updated: 2025-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
260 participants
OBSERVATIONAL
2023-03-15
2023-04-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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COMIRNATY
COVID-19 mRNA vaccine
BNT162b2
BNT162b2 half dose and full dose
Interventions
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BNT162b2
BNT162b2 half dose and full dose
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
12 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer
Jakarta, , Indonesia
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT05621239
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4591050
Identifier Type: -
Identifier Source: org_study_id
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