At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,075 enrolled
Drug / intervention
BNT162b2biological
Likely dose
BNT162b2 0.3 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Special Investigation of COMIRNATY Intramuscular Injection (Investigation of Patients With Underlying Disease Considered to be at High Risk of Aggravation of COVID-19)
In Brief
An observational study evaluating BNT162b2 for COVID-19. Completed, enrolled 1,075 participants across 1 site.
Detailed Summary
Post-marketing study, Cohort study of COMIRNATY vaccines. To collect information on adverse events and COVID-19 observed after vaccination with COMIRNATY and to assess safety in patients with underlying disease considered to be at high risk of aggravation of COVID-19 who have received vaccination with this product under actual use conditions.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
First PostedMay 2021
Enrollment StartMay 2021
Primary CompletionApr 2022
TodayJul 2026
First PostedMay 10, 2021
Enrollment StartMay 26, 2021
Primary CompletionApr 14, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.1 years ago
Interventions
BNT162b2biological
COMIRNATY is administered intramuscularly after dilution as a course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose.