Clinical trial NCT05032976: Korea Comirnaty Post-marketing Surveillance
Official title: A Prospective, Single-arm, Open-label, Non-interventional, Multicenter to Assess the Safety of BNT162b2 in Domestic Post-marketing Surveillance
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Vaccines
Adverse Effects
SARS-CoV-2
Safety
Keywords: COVID-19
Vaccines,
Adverse Effects
SARS-CoV-2
Safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-09-02
Enrollment: 12000
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the subjects who received the BNT162b2 under an approved label for use in Korea in contracted study sites.

Brief 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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Number of subjects with Solicited adverse events
timeFrame: 1 week after administration of BNT162b2 products
measure: Number of subjects with Unsolicited adverse events
timeFrame: 28 days after administration of BNT162b2 products
Secondary outcomes:
measure: Number of subjects with Adverse Events (AEs)
timeFrame: 28 days after administration of BNT162b2 products
measure: Number of subjects with Serious Adverse Events
timeFrame: 28 days after administration of BNT162b2 products
measure: Number of subjects with Expected Adverse Events
timeFrame: 28 days after administration of BNT162b2 products
measure: Number of subjects with Adverse Drug Reactions
timeFrame: 28 days after administration of BNT162b2 products
measure: Number of subjects with Serious Adverse Drug Reactions
timeFrame: 28 days after administration of BNT162b2 products
measure: Number of subjects with Expected Adverse Drug Reactions
timeFrame: 28 days after administration of BNT162b2 products
measure: Number of subjects with Unexpected Adverse Drug Reactions
timeFrame: 28 days after administration of BNT162b2 products
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer Inc
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: