NCT04892888

Survey of the Moderna COVID-19 Vaccine in People at High-Risk of Developing Severe COVID-19 Symptoms

Special Use Results Survey: Spikevax Intramuscular Injection (Previously COVID-19 Vaccine Moderna Intramuscular Injection) for Subjects With Underlying Disease Considered to be at High Risk for Severe Illness, Acute Phase Safety Surveillance (COVID-19)

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This study is a survey of the Moderna COVID-19 vaccine in Japanese people at high risk of developing severe COVID-19 symptoms. 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 side effects of the Moderna COVID-19 vaccine in this group. This will be from the first vaccination to 28 days after the second vaccination. 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: 2022-08-01
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2021-05-19
• Last updated: 2022-07-28

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study