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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-04-30

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.

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Detailed Description

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Conditions

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Coronavirus Disease (COVID-19)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

COVID-19 Vaccine

Intervention Type BIOLOGICAL

COVID-19 Vaccine Intramuscular Injection

Interventions

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COVID-19 Vaccine

COVID-19 Vaccine Intramuscular Injection

Intervention Type BIOLOGICAL

Other Intervention Names

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COVID-19 Vaccine Moderna Intramuscular Injection Spikevax Intramuscular Injection

Eligibility Criteria

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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.