COVID-19, SARS-CoV-2
Conditions
Keywords
COVID-19 Vaccines, Safety, SARS-CoV-2
Brief summary
This study is to assess the post-marketing safety of BNT162b2 products using nationwide population-based database in Republic of Korea.
Detailed description
This study is a retrospective, non-interventional, observational study using Korean Disease Control and Prevention Agency-COVID-19-National Health Insurance Service (K-COV-N) database that includes COVID-19 vaccination/infection and claims data in Korean population. For the primary objective, cohort and self-controlled design will be used for measure of occurrence and measure of association, respectively. For the secondary objective, cohort design will be used for measure of occurrence. Primary objective: * To describe the frequency and estimate the incidence ratio of adverse events of special interest (AESIs) following exposure to Comirnaty Injection among individuals aged 6 months or older in the Republic of Korea * To evaluate the relative risk of AESIs following exposure to Comirnaty Injection among individuals aged 6 months or older in the Republic of Korea, using a self-controlled case series (SCCS) design Secondary objective: \- To describe the frequency and estimate the incidence ratio of severe COVID-19 outcomes (COVID-19 hospital admission, COVID-19 intensive care unit \[ICU\] admission, and COVID-19 death).
Interventions
BIOLOGICALTozinameran (BNT162b2)
1. 12 years or older * Primary series: 2 doses, 30 μg each, administered 21 days apart * Booster shot (dose 3): 1 dose, 30 μg after ≥ 6 months from the second shot 2. 5 to 11 years of age * Primary series: 2 doses, 10 μg each, administered 21 days apart * Booster shot (dose 3): 1 dose, 10 μg after ≥ 6 months from the second shot 3. 6 months to 4 years of age * Primary series: 3 doses (2 doses of 3 μg each, administered 21 days apart, followed by 1 dose after ≥8 weeks)
BIOLOGICALTozinameran (BNT162b2) / Riltozinameran (BNT162b2 OMI BA.1)
1\. 12 years or older \- Single booster dose, 15/15 μg, administered after ≥3 months after primary series
BIOLOGICALTozinameran (BNT162b2) / Famtozinameran (BNT162b2 OMI BA.4-5)
1\. 12 years or older \- Single booster dose, 15/15 μg administered after ≥3 months after primary series
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
1. Primary Objectives 1-1. Measure of Occurrence Inclusion Criteria For the measure of occurrence, analytical populations will include following individuals, * Who meet the predefined criteria for each study population. * With enrollment in the national insurance during the observation period, as well as during the clean window prior to the start of the observation period.
Exclusion criteria
For the measure of occurrence, analytical populations will exclude following individuals, * With diagnosis of AESI during the AESI-specific clean window; or * With diagnosis of AESI between first dose and second/third dose of primary series when analyzing for the second/third dose. 1-2. Measure of Association Inclusion Criteria For the measure of association, analytical populations will include following individuals, * Who meet the predefined criteria for each study population. * With enrollment in the national insurance during the observation period, as well as during the clean window prior to the start of the observation period; and * Who had incident AESI during the observation period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Events of Special Interest (AESI) - Measure of Occurrence | Up to 270 days after vaccination | Measure of Occurrence (Cohort design) The frequency of AESIs will be analyzed. |
| Incidence of Adverse Events of Special Interest (AESI) - Measure of Occurrence | Up to 270 days after vaccination | Measure of Occurrence (Cohort design) The incidence of AESIs will be analyzed. |
| Incidence of Adverse Events of Special Interest (AESI) - Measure of Association | Up to 270 days after vaccination | Measure of Association (Self-Controlled Design) The incidence of AESIs will be analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Severe COVID-19 Outcomes | Up to 150 days after vaccination | The frequency of severe COVID-19 outcomes including COVID-19 hospital admission, COVID-19 Intensive care unit (ICU) admission, and COVID-19 death will be estimated. |
| Incidence of Severe COVID-19 Outcomes | Up to 150 days after vaccination | The incidence of severe COVID-19 outcomes including COVID-19 hospital admission, COVID-19 Intensive care unit (ICU) admission, and COVID-19 death will be estimated. |
Countries
South Korea
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed