Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
12000 participants
OBSERVATIONAL
2022-03-18
2026-04-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tozinameran (BNT162b2)
Subjects aged 6 months and older who are scheduled for Tozinameran vaccination
Tozinameran 12 Years of age and older
BNT162b2 (purple cap) is administered with dilution, while BNT162b2 (grey cap) is administered without dilution. Both formulations are administered by intramuscular injection (IM) of 0.3 mL. According to the approved and authorized label, the recommended dose of BNT162b2 is a series of two doses (1 day 1 dose, 0.3mL each) 21 days apart and administered IM.
Tozinameran 5 to 11 Years of age
BNT162b2 (orange cap) is administered with dilution by intramuscular injection (IM) of 0.2mL. According to the approved and authorized label, the recommended dose of BNT126b2 is a series of two dose (1day 1dose, 0.2mL) 21days apart and administered IM.
But, a third dose may be given at least 28 days after the second dose to individuals who are severely immunocompromised aged 5 to 11 years of age.
Tozinameran 6 months to 4 years of age
BNT162b2 (maroon cap) is administered with dilution by intramuscular injection (IM) of 0.2mL. According to the approved and authorized label, it is recommended that the recommended dose of BNT162b2 is administered by intramuscular injection (IM) twice (once a day, each 0.2mL) at least of 21 days apart, and Dose 3 at least 8 weeks later.
Children who will turn from 4 years to 5 years of age between their doses in the vaccination course should receive their age-appropriate dose at the time of the vaccination and the interval between doses is determined by the child's age at the start of the vaccination course.
The interchangeability of BNT162b2 with COVID-19 vaccines from other manufacturers to complete the vaccination course has not been established.
BNT162b2 (6 months to 4 years of age) should be used only for infants and children 6 months to 4 years of age.
Riltozinameran (BNT162b2 OMI BA.1)
Subject aged 12 years and older who are scheduled for Riltozinameran vaccination
Riltozinameran 12 Years of age and older
The bivalent COVID-19 Vaccine for omicron (BA. 1) (grey cap) is administered by intramuscular injection (IM) of 0.3mL. There should be an interval of at least 3 months between administration of the bivalent COVID-19 Vaccine for omicron (BA. 1) and the last prior dose of a COVID-19 vaccine.
The bivalent COVID-19 Vaccine for omicron (BA. 1) is only indicated for individuals who have previously received at least a primary vaccination course against COVID-19.
Famtozinameran (BNT162b2 OMI BA.4-5)
Subject aged 5 years and older who are scheduled for Famtozinameran vaccination
Famtozinameran 12 Years of age and older
The bivalent COVID-19 Vaccine for omicron (BA. 4-5) (grey cap) is administered by intramuscular injection (IM) of 0.3mL. There should be an interval of at least 3 months between administration of the bivalent COVID-19 Vaccine for omicron (BA. 4-5) and the last prior dose of a COVID-19 vaccine.
The bivalent COVID-19 Vaccine for omicron (BA. 4-5) is only indicated for individuals who have previously received at least a primary vaccination course against COVID-19.
Famtozinameran 5 to 11 Years of age
The bivalent COVID-19 Vaccine for omicron (BA. 4-5) for 5 to 11 years of age (orange cap) is administered after dilution by intramuscular injection (IM) of 0.2mL. There should be an interval of at least 3 months between administration of the bivalent COVID-19 Vaccine for omicron (BA. 4-5) for 5 to 11 years of age and the last prior dose of a COVID-19 vaccine.
The bivalent COVID-19 Vaccine for omicron (BA. 4-5) for 5 to 11 years of age is only indicated for individuals who have previously received at least a primary vaccination course against COVID-19.
Raxtozinameran (BNT162b2 OMI XBB.1.5)
Subject aged 6 months to 4 years and 12 years and older who are scheduled for Raxtozinameran vaccination
Raxtozinameran 12 years of age and older
BNT162b2 OMI XBB.1.5 (grey cap) is administered intramuscularly as a single dose of 0.3 mL for individuals 12 years of age and older regardless of prior COVID-19 vaccination status.
For individuals who have previously been vaccinated with a COVID-19 vaccine, BNT162b2 OMI XBB.1.5 should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Raxtozinameran 6 months to 4 years of age
BNT162b2 OMI XBB.1.5 (maroon cap) is administered intramuscularly after dilution. For infants and children 6 months to 4 years of age without history of completion of a COVID-19, each 0.2 mL of dose is administered for a total of three vaccinations. The second dose is administered 3 weeks after the first dose followed by a third dose administered at least 8 weeks after the second dose. For infants and children 6 months to 4 years of age with history of completion of a COVID-19 primary course or prior SARS CoV-2 infection, a single dose of 0.2 mL is administered.
Interventions
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Tozinameran 12 Years of age and older
BNT162b2 (purple cap) is administered with dilution, while BNT162b2 (grey cap) is administered without dilution. Both formulations are administered by intramuscular injection (IM) of 0.3 mL. According to the approved and authorized label, the recommended dose of BNT162b2 is a series of two doses (1 day 1 dose, 0.3mL each) 21 days apart and administered IM.
Tozinameran 5 to 11 Years of age
BNT162b2 (orange cap) is administered with dilution by intramuscular injection (IM) of 0.2mL. According to the approved and authorized label, the recommended dose of BNT126b2 is a series of two dose (1day 1dose, 0.2mL) 21days apart and administered IM.
But, a third dose may be given at least 28 days after the second dose to individuals who are severely immunocompromised aged 5 to 11 years of age.
Tozinameran 6 months to 4 years of age
BNT162b2 (maroon cap) is administered with dilution by intramuscular injection (IM) of 0.2mL. According to the approved and authorized label, it is recommended that the recommended dose of BNT162b2 is administered by intramuscular injection (IM) twice (once a day, each 0.2mL) at least of 21 days apart, and Dose 3 at least 8 weeks later.
Children who will turn from 4 years to 5 years of age between their doses in the vaccination course should receive their age-appropriate dose at the time of the vaccination and the interval between doses is determined by the child's age at the start of the vaccination course.
The interchangeability of BNT162b2 with COVID-19 vaccines from other manufacturers to complete the vaccination course has not been established.
BNT162b2 (6 months to 4 years of age) should be used only for infants and children 6 months to 4 years of age.
Riltozinameran 12 Years of age and older
The bivalent COVID-19 Vaccine for omicron (BA. 1) (grey cap) is administered by intramuscular injection (IM) of 0.3mL. There should be an interval of at least 3 months between administration of the bivalent COVID-19 Vaccine for omicron (BA. 1) and the last prior dose of a COVID-19 vaccine.
The bivalent COVID-19 Vaccine for omicron (BA. 1) is only indicated for individuals who have previously received at least a primary vaccination course against COVID-19.
Famtozinameran 12 Years of age and older
The bivalent COVID-19 Vaccine for omicron (BA. 4-5) (grey cap) is administered by intramuscular injection (IM) of 0.3mL. There should be an interval of at least 3 months between administration of the bivalent COVID-19 Vaccine for omicron (BA. 4-5) and the last prior dose of a COVID-19 vaccine.
The bivalent COVID-19 Vaccine for omicron (BA. 4-5) is only indicated for individuals who have previously received at least a primary vaccination course against COVID-19.
Famtozinameran 5 to 11 Years of age
The bivalent COVID-19 Vaccine for omicron (BA. 4-5) for 5 to 11 years of age (orange cap) is administered after dilution by intramuscular injection (IM) of 0.2mL. There should be an interval of at least 3 months between administration of the bivalent COVID-19 Vaccine for omicron (BA. 4-5) for 5 to 11 years of age and the last prior dose of a COVID-19 vaccine.
The bivalent COVID-19 Vaccine for omicron (BA. 4-5) for 5 to 11 years of age is only indicated for individuals who have previously received at least a primary vaccination course against COVID-19.
Raxtozinameran 12 years of age and older
BNT162b2 OMI XBB.1.5 (grey cap) is administered intramuscularly as a single dose of 0.3 mL for individuals 12 years of age and older regardless of prior COVID-19 vaccination status.
For individuals who have previously been vaccinated with a COVID-19 vaccine, BNT162b2 OMI XBB.1.5 should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Raxtozinameran 6 months to 4 years of age
BNT162b2 OMI XBB.1.5 (maroon cap) is administered intramuscularly after dilution. For infants and children 6 months to 4 years of age without history of completion of a COVID-19, each 0.2 mL of dose is administered for a total of three vaccinations. The second dose is administered 3 weeks after the first dose followed by a third dose administered at least 8 weeks after the second dose. For infants and children 6 months to 4 years of age with history of completion of a COVID-19 primary course or prior SARS CoV-2 infection, a single dose of 0.2 mL is administered.
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
2. Subjects with a history of hypersensitivity to any ingredients of this product or this product
6 Months
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer
Seoul, , South Korea
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT05032976
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4591025
Identifier Type: -
Identifier Source: org_study_id
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