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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031210095 | Registry Identifier | jRCT |
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This study is a survey of the Moderna COVID-19 vaccine in Japanese people at high risk of developing severe COVID-19 symptoms. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for side effects of the Moderna COVID-19 vaccine in this group. This will be from the first vaccination to 28 days after the second vaccination.
The number of visits to the clinic will depend on the clinic's standard practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 Vaccine Intramuscular Injection 0.5 mL | COVID-19 vaccine intramuscular injection, 2 doses of 0.5 mL per dose administered intramuscularly at an interval of 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Vaccine | Biological | COVID-19 Vaccine Intramuscular Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with at least One Adverse Events (AEs) | 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. | 56 days |
| Percentage of Participants with Specified AEs (Local Reactions) at the Vaccination Site | 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. | 56 days |
| Percentage of Participants with Specified AEs (Systemic Events) | 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. | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Take COVID-19 Pathogen (SARS-COV-2) Test during the Study | 56 days | |
| Number of Participants who Developed COVID-19 during the Study | 56 days | |
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Inclusion Criteria:
Exclusion Criteria:
1. The subject has any contraindication to this drug.
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The population of this survey are vaccinees who meet the inclusion/exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Selected Site | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Number of Participants Who Have Sever COVID-19 Infection during the Study Evaluated by Investigator |
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)". |
| 56 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |