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Clinical Trial Summary

This study will collect information on the safety of COMIRNATY for at least 3,000 subjects who have been administered in a routine clinical practice for 6 years after COMIRNATY is approved for use in Korea, and will be conducted in accordance with the New Drug Re-Examination Guideline of the Ministry of Food and Drug Safety (MFDS).


Clinical Trial Description

This is an open-label, non-comparative, non-interventional, prospective, and multi-center study conducted in Korean health care centers by accredited physicians to evaluate the safety of COMIRNATY in Korean subjects aged 12 or older who are scheduled for the vaccination. COMIRNATY 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). About 3000 subjects will be enrolled in several centers in this study. 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 consecutively prepare the CRFs from the subjects who this vaccine was administered to first after the start date of the study. Each investigator will sequentially enroll all subjects to whom COMIRNATY 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. 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 28 days after the second injection 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. Safety is the primary interest of this study, which will be assessed based on adverse events (AEs) that occur during 28days from the first and the last dose of COMIRNATY. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05032976
Study type Observational
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email [email protected]
Status Not yet recruiting
Phase
Start date September 30, 2021
Completion date March 4, 2027

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