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Secondary Databased Post-marketing Surveillance Study of BNT162b2 | Clinical Trials | Clareo Health

COMPLETED

Secondary Databased Post-marketing Surveillance Study of BNT162b2

NCT06743334•Pfizer

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 occurrence and measure of association, respectively. For the secondary objective, cohort design will be used for measure of occurrence. Primary objective: * To describe the frequency and estimate the incidence ratio of adverse events of special interest (AESIs) following exposure to Comirnaty Injection among individuals aged 6 months or older in the Republic of Korea * To evaluate the relative risk of AESIs following exposure to Comirnaty Injection among individuals aged 6 months or older in the Republic of Korea, using a self-controlled case series (SCCS) design Secondary objective: \- To describe the frequency and estimate the incidence ratio of severe COVID-19 outcomes (COVID-19 hospital admission, COVID-19 intensive care unit \[ICU\] admission, and COVID-19 death).

Eligibility

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•* Who meet the predefined criteria for each study population.
•* With enrollment in the national insurance during the observation period, as well as during the clean window prior to the start of the observation period.
•* Who meet the predefined criteria for each study population.
•* With enrollment in the national insurance during the observation period, as well as during the clean window prior to the start of the observation period; and

Exclusion Criteria

•* With diagnosis of AESI during the AESI-specific clean window; or
•* With diagnosis of AESI between first dose and second/third dose of primary series when analyzing for the second/third dose.
•* Who do not have both risk and control window time. If an individual disenrolls, dies, or reaches the end of the study period during the risk window prior to accumulating any control window time, he/she will be excluded; or
•* With a diagnosis of AESI during the AESI-specific clean window.
•* None

Locations (1)

Pfizer

Seoul, South Korea

Key Dates

Start Date

April 23, 2025

Primary Completion Date

May 28, 2025

Completion Date

May 28, 2025

Last Updated

June 10, 2025

Enrollment

ACTUAL participants

Conditions

COVID-19SARS-CoV-2

Interventions

Tozinameran (BNT162b2)

BIOLOGICAL

Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1)

BIOLOGICAL

Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5)

BIOLOGICAL

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

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COVID-19

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RECRUITINGNA

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Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Secondary Databased Post-marketing Surveillance Study of BNT162b2

Inclusion Criteria

Exclusion Criteria

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

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