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

May 17, 2023 updated by: ModernaTX, Inc.

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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8538

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Moderna selected site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The population of this survey are vaccinated participants who meet the inclusion/exclusion criteria.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Biological: COVID-19 Vaccine
COVID-19 Vaccine Intramuscular Injection
Other Names:
  • COVID-19 Vaccine Moderna Intramuscular Injection
  • Spikevax Intramuscular Injection

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2021

Primary Completion (Actual)

April 28, 2023

Study Completion (Actual)

April 28, 2023

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

June 25, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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