Prevention of infectious disease caused by SARS-CoV-2
Conditions
Interventions
None listed
Sponsors
Contact for Clinical Trial Information
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The participant is capable of understanding the contents of the investigation, recording his/her own symptoms in the health observation diary, and has obtained written consent to participate in the investigation from the vaccinee himself/herself (If minor, parent or legal guardian). 2. The participant has an underlying disease at the time of this drug vaccination that is considered to pose a high risk of aggravation of COVID-19.
Exclusion criteria
Exclusion criteria: 1. The subject has any contraindication to this drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Percentage of Participants with at least One Adverse Events (AEs) Time Frame: 56 days An adverse event (Adverse Event: AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product. It does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (Including laboratory abnormalities), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 2.Percentage of Participants with Specified AEs (Local Reactions) at the Vaccination Site Time Frame: 56 days Specified AEs (Local reactions) at the vaccination site are defined as injection site pain, redness and swelling. The participants will evaluate the symptoms at the vaccination site (local reactions) and systemic symptoms (systemic events) and will record with the health observation diary. Percentage of participants with specified AEs (local reactions) at the vaccination site will be reported. 3.Percentage of Participants with Specified AEs (Systemic Events) Time Frame: 56 days Specified AEs (Systemic events) are defined as vomiting, diarrhoea, headache, malaise, chills, myalgia, and arthralgia. The participants will evaluate the symptoms at the vaccination site (local reactions) and systemic symptoms (systemic events) and will record with the health observation diary. Percentage of participants with specified AEs (systemic events) at the vaccination site will be reported. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Number of Participants who Take COVID-19 Pathogen (SARS-COV-2) Test during the Study Time Frame: 56 days 2.Number of Participants who Developed COVID-19 during the Study Time Frame: 56 days 3.Number of Participants Who Have Sever COVID-19 Infection during the Study Evaluated by Investigator Time Frame: 56 days Number of participants who have sever COVID-19 infection during the study evaluated by investigator will be reported. Investigator will evaluate the severity of COVID-19 infection with COVID-19 information entered in the case report form in reference to "Guidance for Clinical Practice of Novel Coronavirus Infection (COVID-19)". | — |
Contacts
Public ContactTrial Information Contact for Clinical
Takeda Pharmaceutical Company Limited
Outcome results
None listed