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Secondary Databased Post-marketing Surveillance Study of BNT162b2

NCT06743334 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2025-06-10

No results posted yet for this study

Summary

This study is to assess the post-marketing safety of BNT162b2 products using nationwide population-based database in Republic of Korea.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-23
Primary Completion
2025-05-28
Completion
2025-05-28

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06743334 on ClinicalTrials.gov