N/A
Completed N=14,570
Drug Use Investigation of COMIRNATY Intramuscular Injection
Source: ClinicalTrials.gov NCT04815031 ↗Enrolled (actual)
14,570
Serious AEs
0.6%
Results posted
Oct 2024
Primary outcomePrimary: Proportion of Participants With Serious Adverse Events — 0.83 Percentage of Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Serious Adverse Events |
0.83 | — |
| PRIMARY Proportion of Participants With Severe COVID-19 |
— | — |
| PRIMARY Proportion of Participants With Serious Adverse Reactions |
0.03 | — |
| PRIMARY Number of Participants With Serious Adverse Events After Booster Vaccination |
48 | — |
| PRIMARY Number of Participants With Severe COVID-19 After Booster Vaccination |
— | — |
| PRIMARY Number of Participants With Serious Adverse Reactions After Booster Vaccination |
2 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have participated in the Investigation of Health Status of Recipients Vaccinated First and have provided written consent to continue participation in this study.
Exclusion Criteria
- No exclusion criteria.
Data sourced from ClinicalTrials.gov (NCT04815031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.