Active — Not RecruitingNot Applicable

Korea Comirnaty Post-marketing Surveillance

South Korea12,000 participantsStarted 2022-03-18

Plain-language summary

This study will collect information on the safety of BNT162b2 products for subjects who have been administered in a routine clinical practice from 05Mar2021 to 04Mar2027 in Korea, and will be conducted in accordance with the New Drug Re-Examination Guideline of the Ministry of Food and Drug Safety (MFDS).

Who can participate

Age range6 Months

SexALL

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Inclusion criteria

✓. Korean subjects who are eligible for administration of BNT162b2 products (Including bivalent COVID-19 Vaccines for omicron) according to the locally approved and authorized label (indication, age criteria etc.)
✓. Evidence of a personally signed and dated data privacy statement indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study - Data privacy statement signed by the subjects and parents or legal representative for subjects aged under 19

Exclusion criteria

✕. Subjects who involved in the contraindications of use indicated in the locally approved and authorized label
✕. Subjects with a history of hypersensitivity to any ingredients of this product or this product

What they're measuring

Number of subjects with Solicited adverse events

Timeframe: 1 week after administration of BNT162b2 products

Number of subjects with Unsolicited adverse events

Timeframe: 28 days after administration of BNT162b2 products

Trial details

NCT IDNCT05032976

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-01-24

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