Korea Comirnaty Post-marketing Surveillance

Pfizer

Status: Active, not recruiting

Conditions: COVID-19; Adverse Effects; Vaccines; SARS-CoV-2; Safety

Treatments: Biological: Tozinameran 6 months to 4 years of age; Biological: Tozinameran 12 Years of age and older; Biological: Riltozinameran 12 Years of age and older; Biological: Raxtozinameran 6 months to 4 years of age; Biological: Famtozinameran 12 Years of age and older; Biological: Raxtozinameran 12 years of age and older; Biological: Famtozinameran 5 to 11 Years of age; Biological: Tozinameran 5 to 11 Years of age

Study type: Observational

Funder types: Industry

Identifiers

NCT05032976

NCT05032976 (Registry Identifier)

C4591025

Details and patient eligibility

About

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).

Full description

This is an open-label, non-comparative, non-interventional, prospective, and multi-center study conducted in Korean health care centers by accredited physicians (investigator). The study population is Korean subjects who are scheduled for COVID-19 vaccination. BNT162b2 products will be administered according to the "Dosage and Administration" of the approved labeling. There is no visit or activity mandated by this study. The investigator will collect data from the subject's medical records and patient (subject) report outcome (PRO), and record the information on each subject's case report form (CRF).

Pfizer Pharmaceuticals Korea will conclude a post-marketing surveillance agreement with an investigator site before performing the study. Investigators at the institution that sign the agreement should prepare the CRFs from all the subjects who this vaccine was administered to after the start date of the study.

Each investigator will sequentially enroll all subjects to whom BNT162b2 products is prescribed for the first time according to the local product document and who agree to participate in this study by signing the data privacy statement used in place of the informed consent form until the total requested cases per center are collected for this study.

An electronic diary will be used in this study to collect adverse events that occur after injection. Follow-up exams will be carried out from after the first injection to before the second injection, and from after the second injection to 28 days after the second injection. Those who received booster doses will be followed up for the 28 days from the date of the booster dose. For the follow-up adverse event CRF, either an application using the mobile phones of subjects or entry on a paper questionnaire may be selected. The CRF will be filled out every day after the first and second injections. If an application is used, it is automatically sent as an eCRF. If a paper questionnaire is used, the questionnaire filled out after the first injection is collected at the time of the visit for the second injection, and the questionnaires filled out after the second injection and booster dose are collected 28 days after the second injection and 28 days after the booster dose respectively by mail.

To promote the collection of adverse events after injection, a reminder may be given by phone about entering the information and the collection of the CRF to subjects who gave consent beforehand. If it is difficult to record CRF due to the subject, the occurrence of adverse events can be confirmed by phone.

Safety is the primary interest of this study, which will be assessed based on adverse events (AEs) that occur during 28 days from the date of the first, second and booster doses of BNT162b2.

Enrollment: 12,000 estimated patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. 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.)
2. 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

2. Exclusion criteria Subjects meeting any of the following criteria will be excluded in the study

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

Trial design

12,000 participants in 4 patient groups

Tozinameran (BNT162b2)

Description:

Subjects aged 6 months and older who are scheduled for Tozinameran vaccination

Treatment:

Biological: Tozinameran 5 to 11 Years of age

Biological: Tozinameran 12 Years of age and older

Biological: Tozinameran 6 months to 4 years of age

Riltozinameran (BNT162b2 OMI BA.1)

Description:

Subject aged 12 years and older who are scheduled for Riltozinameran vaccination

Treatment:

Biological: Riltozinameran 12 Years of age and older

Famtozinameran (BNT162b2 OMI BA.4-5)

Description:

Subject aged 5 years and older who are scheduled for Famtozinameran vaccination

Treatment:

Biological: Famtozinameran 5 to 11 Years of age

Biological: Famtozinameran 12 Years of age and older

Raxtozinameran (BNT162b2 OMI XBB.1.5)

Description:

Subject aged 6 months to 4 years and 12 years and older who are scheduled for Raxtozinameran vaccination

Treatment:

Biological: Raxtozinameran 12 years of age and older

Biological: Raxtozinameran 6 months to 4 years of age