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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8,538 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Coronavirus Disease (COVID-19)

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 Vaccine	COVID-19 Vaccine Intramuscular Injection

Timeline

• Start date: 2021-12-22
• Primary completion: 2023-04-28
• Completion: 2023-04-28
• First posted: 2021-06-28
• Last updated: 2023-05-19

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study