At a glance
ClinicalIndex Comparison RecordN/ACompleted· 14,570 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.
General Investigation of COMIRNATY Intramuscular Injection (Follow-up Study for Subjects [Healthcare Professionals] Who Are Vaccinated at an Early Post-Approval Stage)
In Brief
An observational study evaluating BNT162b2 for COVID-19. Completed, enrolled 14,570 participants across 1 site.
Detailed Summary
Post-marketing study, Chotor study of COMIRNATY vaccenees followed for 11months. Serious adverse events and COVID-19 observed during the follow-up period will be collected, and the long-term safety of this product will be assessed.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
Enrollment StartMar 2021
First PostedMar 2021
Primary CompletionJan 2023
TodayJul 2026
First PostedMar 24, 2021
Enrollment StartMar 20, 2021
Primary CompletionJan 27, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.3 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. Individuals 16 years of age and older.