- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04941144
Long-Term Follow-up Survey of COVID-19 Vaccine After Vaccination
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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Tokyo, Japan
- Moderna selected site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
COVID-19 Vaccine Intramuscular Injection 0.5 milliliters (mL)
COVID-19 vaccine intramuscular injection, 2 doses of 0.5 mL per dose administered intramuscularly at an interval of 4 weeks.
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COVID-19 Vaccine Intramuscular Injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants with Serious Adverse Events (SAE)
Time Frame: 11 months (From 28 days to 12 months after the second vaccination)
|
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.
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11 months (From 28 days to 12 months after the second vaccination)
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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
Time Frame: 11 months (From 28 days to 12 months after the second vaccination)
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11 months (From 28 days to 12 months after the second vaccination)
|
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Number of Participants who Developed COVID-19 during the Study
Time Frame: 11 months (From 28 days to 12 months after the second vaccination)
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11 months (From 28 days to 12 months after the second vaccination)
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Number of Participants Who Have Severe COVID-19 Infection during the Study Evaluated by Investigator
Time Frame: 11 months (From 28 days to 12 months after the second vaccination)
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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)".
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11 months (From 28 days to 12 months after the second vaccination)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- mRNA-1273-P918
- jRCT2031210168 (Registry Identifier: jRCT)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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