Long-Term Follow-up Survey of COVID-19 Vaccine After Vaccination

Study Overview
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Brief Summary
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This study is a long-term follow-up survey of Japanese people after their second vaccination with the Moderna COVID-19 vaccine. 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 long-term side effects of the COVID-19 vaccine. This will be from 28 days to 12 months after the second vaccination of the COVID-19 vaccine. The number of visits to the clinic will depend on the clinic's standard practice.

Official Title
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General Use Results Survey: Spikevax Intramuscular Injection (Previously COVID-19 Vaccine Moderna Intramuscular Injection) During the Early Phase of Treatment With Novel Corona Vaccine, Follow-up of Key Survey Participants

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: Participants who have participated in the preceding cohort study and has subsequently provided written consent to participate in this study. Exclusion Criteria: None
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 milliliters (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 Serious Adverse Events (SAE) | An SAE is defined as any untoward medical occurrence that: Results in death, Is life-threatening, Requires in patient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Leads to a congenital anomaly/birth defect in the offspring of a participant, or Is an important medical event. | 11 months (From 28 days to 12 months after the second vaccination) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who Take COVID-19 Pathogen (Severe Acute Respiratory Syndrome coronavirus [SARS-CoV-2]) Test during the Study |  | 11 months (From 28 days to 12 months after the second vaccination) | 
| Number of Participants who Developed COVID-19 during the Study |  | 11 months (From 28 days to 12 months after the second vaccination) | 
| Number of Participants Who Have Severe COVID-19 Infection during the Study Evaluated by Investigator | Number of participants who have severe 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). | 11 months (From 28 days to 12 months after the second vaccination) |