Secondary Databased Post-marketing Surveillance Study of BNT162b2
- Registration Number
- NCT06743334
- Lead Sponsor
- Pfizer
- Brief Summary
This study is to assess the post-marketing safety of BNT162b2 products using nationwide population-based database in Republic of Korea.
- Detailed Description
This study is a retrospective, non-interventional, observational study using Korean Disease Control and Prevention Agency-COVID-19-National Health Insurance Service (K-COV-N) database that includes COVID-19 vaccination/infection and claims data in Korean population. For the primary objective, cohort and self-controlled design will be used for measure of occu...
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 10890000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All primary series recipients using monovalent vaccine Tozinameran (BNT162b2) All individuals who received first dose with monovalent vaccine as primary series (6 months or older). First booster recipients with monovalent vaccine Tozinameran (BNT162b2) All individuals who received first booster recipients with monovalent vaccine (5 years of age or older). Second booster recipients with monovalent vaccine Tozinameran (BNT162b2) All individuals who received second booster recipients with monovalent vaccine (5 years of age or older). All booster recipients using bivalent vaccine Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1) All individuals who received booster recipients using bivalent vaccine (12 years of age or older). All booster recipients using bivalent vaccine Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5) All individuals who received booster recipients using bivalent vaccine (12 years of age or older). Single-dose primary series recipients with bivalent vaccine Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1) All individuals who received single-dose primary series recipients with bivalent vaccine (12 years of age or older). Single-dose primary series recipients with bivalent vaccine Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5) All individuals who received single-dose primary series recipients with bivalent vaccine (12 years of age or older). Primary series recipients with first dose of monovalent vaccine and second dose of bivalent vaccine Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1) All individuals who received primary series recipients with first dose of monovalent vaccine and second dose of bivalent vaccine (12 years of age or older). Primary series recipients with first dose of monovalent vaccine and second dose of bivalent vaccine Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5) All individuals who received primary series recipients with first dose of monovalent vaccine and second dose of bivalent vaccine (12 years of age or older).
- Primary Outcome Measures
Name Time Method Frequency of Adverse Events of Special Interest (AESI) - Measure of Occurrence Up to 270 days after vaccination Measure of Occurrence (Cohort design) The frequency of AESIs will be analyzed.
Incidence of Adverse Events of Special Interest (AESI) - Measure of Occurrence Up to 270 days after vaccination Measure of Occurrence (Cohort design) The incidence of AESIs will be analyzed.
Incidence of Adverse Events of Special Interest (AESI) - Measure of Association Up to 270 days after vaccination Measure of Association (Self-Controlled Design) The incidence of AESIs will be analyzed.
- Secondary Outcome Measures
Name Time Method Frequency of Severe COVID-19 Outcomes Up to 150 days after vaccination The frequency of severe COVID-19 outcomes including COVID-19 hospital admission, COVID-19 Intensive care unit (ICU) admission, and COVID-19 death will be estimated.
Incidence of Severe COVID-19 Outcomes Up to 150 days after vaccination The incidence of severe COVID-19 outcomes including COVID-19 hospital admission, COVID-19 Intensive care unit (ICU) admission, and COVID-19 death will be estimated.
Trial Locations
- Locations (1)
Pfizer Korea
🇰🇷Seoul, Korea, Republic of