Korea Comirnaty Post-marketing Surveillance

Active, not recruitingOBSERVATIONAL
Enrollment

12,000

Participants

Timeline

Start Date

March 18, 2022

Primary Completion Date

March 4, 2027

Study Completion Date

March 4, 2027

Conditions
COVID-19VaccinesAdverse EffectsSARS-CoV-2Safety
Interventions
BIOLOGICAL

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.

BIOLOGICAL

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."

BIOLOGICAL

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."

BIOLOGICAL

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."

BIOLOGICAL

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."

BIOLOGICAL

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."

BIOLOGICAL

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."

BIOLOGICAL

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.

Trial Locations (1)

Unknown

Pfizer Inc, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT05032976 - Korea Comirnaty Post-marketing Surveillance | Biotech Hunter | Biotech Hunter