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

Coronavirus Disease (COVID-19) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04941144
• Other study ID #: mRNA-1273-P918
• Secondary ID: jRCT2031210168
• Status: Completed
• Start date: December 22, 2021
• Est. completion date: April 28, 2023

Study information

• Verified date: May 2023
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8538
• Est. completion date: April 28, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Disease (COVID-19)
• COVID-19

Intervention

Biological:
• COVID-19 Vaccine
COVID-19 Vaccine Intramuscular Injection

Locations

Country	Name	City	State
Japan	Moderna selected site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	11 months (From 28 days to 12 months after the second vaccination)
Secondary	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)
Secondary	Number of Participants who Developed COVID-19 during the Study		11 months (From 28 days to 12 months after the second vaccination)
Secondary	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)".	11 months (From 28 days to 12 months after the second vaccination)