N/A
Completed N=1,075
Special Investigation of COMIRNATY in the Population With Underlying Diseases
Source: ClinicalTrials.gov NCT04880447 ↗Enrolled (actual)
1,075
Serious AEs
1.1%
Results posted
Jun 2024
Primary outcomePrimary: Proportion of Participants With Adverse Reactions — 59; 30; 39 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Adverse Reactions |
59; 30; 39 | — |
| PRIMARY Proportion of Participants With Serious Adverse Reactions |
3; 1; 2 | — |
| PRIMARY Proportion of Participants With Local Reactions and Systemic Reactions (The First Vaccination) |
836; 648 | — |
| PRIMARY Proportion of Participants With Local Reactions and Systemic Reactions (The Second Vaccination) |
866; 716 | — |
Eligibility Criteria
Inclusion Criteria
-Subjects who are able to understand the content of this study and to record their symptoms in the health observation diary, and who have provided written consent to participate in this survey by themselves (or parents or legal guardians in the case of minors)
Exclusion Criteria
- There are no exclusion criteria for this study.
Data sourced from ClinicalTrials.gov (NCT04880447). 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.