NCT06743334

Secondary Databased Post-marketing Surveillance Study of BNT162b2

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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).

Conditions

• COVID-19
• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	Tozinameran (BNT162b2)	1. 12 years or older * Primary series: 2 doses, 30 μg each, administered 21 days apart * Booster shot (dose 3): 1 dose, 30 μg after ≥ 6 months from the second shot 2. 5 to 11 years of age * Primary series: 2 doses, 10 μg each, administered 21 days apart * Booster shot (dose 3): 1 dose, 10 μg after ≥ 6 months from the second shot 3. 6 months to 4 years of age * Primary series: 3 doses (2 doses of 3 μg each, administered 21 days apart, followed by 1 dose after ≥8 weeks)
BIOLOGICAL	Tozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1)	1\. 12 years or older \- Single booster dose, 15/15 μg, administered after ≥3 months after primary series
BIOLOGICAL	Tozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5)	1\. 12 years or older \- Single booster dose, 15/15 μg administered after ≥3 months after primary series

Timeline

• Start date: 2025-04-23
• Primary completion: 2025-05-28
• Completion: 2025-05-28
• First posted: 2024-12-19
• Last updated: 2025-06-10

Locations

1 site across 1 country: South Korea