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

Completed

• Conditions: Coronavirus Disease (COVID-19)
• Interventions: Biological: COVID-19 Vaccine

• Registration Number: NCT04941144
• Lead Sponsor: ModernaTX, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-06-25
• Study First Posted: 2021-06-28
• Study Start: 2021-12-22
• Primary Completion: 2023-04-28
• Study Completion: 2023-04-28
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8538

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 Vaccine Intramuscular Injection 0.5 milliliters (mL)	COVID-19 Vaccine	COVID-19 vaccine intramuscular injection, 2 doses of 0.5 mL per dose administered intramuscularly at an interval of 4 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Serious Adverse Events (SAE)	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.

Secondary Outcome Measures

Name	Time	Method
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 Have Severe COVID-19 Infection during the Study Evaluated by Investigator	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)".
Number of Participants who Developed COVID-19 during the Study	11 months (From 28 days to 12 months after the second vaccination)

Trial Locations

Locations (1)

Moderna selected site; 🇯🇵 Tokyo, Japan