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

ModernaTX, Inc.8,538 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

8,538

Conditions

Coronavirus Disease (COVID-19)

Interventions

COVID-19 VaccineBIOLOGICAL

COVID-19 Vaccine Intramuscular Injection

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Moderna selected site

Tokyo, Japan

Outcomes

Primary Outcomes

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.

Time frame: 11 months (From 28 days to 12 months after the second vaccination)

Secondary Outcomes

Number of Participants who Take COVID-19 Pathogen (Severe Acute Respiratory Syndrome coronavirus [SARS-CoV-2]) Test during the Study

Time frame: 11 months (From 28 days to 12 months after the second vaccination)

Number of Participants who Developed COVID-19 during the Study

Time frame: 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)".

Time frame: 11 months (From 28 days to 12 months after the second vaccination)

Data from ClinicalTrials.gov

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