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

Takeda

Status: Withdrawn

Conditions: Coronavirus Disease (COVID-19)

Treatments: Biological: COVID-19 Vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT04892888

jRCT2031210095 (Registry Identifier)

PNR-1475

Details and patient eligibility

About

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.

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. The participant is capable of understanding the contents of the investigation, recording his/her own symptoms in the health observation diary, and has obtained written consent to participate in the investigation from the vaccinee himself/herself (If minor, parent or legal guardian).
2. The participant has an underlying disease at the time of this drug vaccination that is considered to pose a high risk of aggravation of COVID-19.

Exclusion criteria

1. The subject has any contraindication to this drug.

Trial design

0 participants in 1 patient group

COVID-19 Vaccine Intramuscular Injection 0.5 mL

Description:

COVID-19 vaccine intramuscular injection, 2 doses of 0.5 mL per dose administered intramuscularly at an interval of 4 weeks.

Treatment:

Biological: COVID-19 Vaccine