Secondary Databased Post-marketing Surveillance Study of BNT162b2

NCT ID: NCT06743334

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-23
• Study Completion Date: 2025-05-28

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 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

All primary series recipients using monovalent vaccine

All individuals who received first dose with monovalent vaccine as primary series (6 months or older).

Tozinameran (BNT162b2)

Intervention Type: BIOLOGICAL

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)

First booster recipients with monovalent vaccine

All individuals who received first booster recipients with monovalent vaccine (5 years of age or older).

Tozinameran (BNT162b2)

Intervention Type: BIOLOGICAL

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)

Second booster recipients with monovalent vaccine

All individuals who received second booster recipients with monovalent vaccine (5 years of age or older).

Tozinameran (BNT162b2)

Intervention Type: BIOLOGICAL

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)

All booster recipients using bivalent vaccine

All individuals who received booster recipients using bivalent vaccine (12 years of age or older).

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

Intervention Type: BIOLOGICAL

1. 12 years or older

• Single booster dose, 15/15 μg, administered after ≥3 months after primary series

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

Intervention Type: BIOLOGICAL

1. 12 years or older

• Single booster dose, 15/15 μg administered after ≥3 months after primary series

Single-dose primary series recipients with bivalent vaccine

All individuals who received single-dose primary series recipients with bivalent vaccine (12 years of age or older).

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

Intervention Type: BIOLOGICAL

1. 12 years or older

• Single booster dose, 15/15 μg, administered after ≥3 months after primary series

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

Intervention Type: BIOLOGICAL

1. 12 years or older

• Single booster dose, 15/15 μg administered after ≥3 months after primary series

Primary series recipients with first dose of monovalent vaccine and second dose of bivalent vaccine

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).

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

Intervention Type: BIOLOGICAL

1. 12 years or older

• Single booster dose, 15/15 μg, administered after ≥3 months after primary series

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

Intervention Type: BIOLOGICAL

1. 12 years or older

• Single booster dose, 15/15 μg administered after ≥3 months after primary series

Interventions

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)

Intervention Type: 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

Intervention Type: 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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer

Seoul, , South Korea

Countries

South Korea

Other Identifiers

C4591056

Identifier Type: -

Identifier Source: org_study_id