Survey of the Moderna COVID-19 Vaccine in People at High-Risk of Developing Severe COVID-19 Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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Special Use Results Survey: Spikevax Intramuscular Injection (Previously COVID-19 Vaccine Moderna Intramuscular Injection) for Subjects With Underlying Disease Considered to be at High Risk for Severe Illness, Acute Phase Safety Surveillance (COVID-19)

Conditions
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Coronavirus Disease (COVID-19)

Intervention / Treatment
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* Biological: COVID-19 Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). 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: 1. The subject has any contraindication to this drug.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 Vaccine Intramuscular Injection 0.5 mL<br>COVID-19 vaccine intramuscular injection, 2 doses of 0.5 mL per dose administered intramuscularly at an interval of 4 weeks. | Biological: COVID-19 Vaccine<br>* COVID-19 Vaccine Intramuscular Injection<br>* Other names: Spikevax Intramuscular Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |