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

Takeda

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Coronavirus Disease (COVID-19)

Interventions

COVID-19 VaccineBIOLOGICAL

COVID-19 Vaccine Intramuscular Injection

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Takeda Selected Site

Tokyo, Japan

Outcomes

Primary Outcomes

Percentage of Participants with at least One Adverse Events (AEs)

An adverse event (Adverse Event: AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product. It does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (Including laboratory abnormalities), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Time frame: 56 days

Percentage of Participants with Specified AEs (Local Reactions) at the Vaccination Site

Specified AEs (Local reactions) at the vaccination site are defined as injection site pain, redness and swelling. The participants will evaluate the symptoms at the vaccination site (local reactions) and systemic symptoms (systemic events) and will record with the health observation diary. Percentage of participants with specified AEs (local reactions) at the vaccination site will be reported.

Time frame: 56 days

Percentage of Participants with Specified AEs (Systemic Events)

Specified AEs (Systemic events) are defined as vomiting, diarrhoea, headache, malaise, chills, myalgia, and arthralgia. The participants will evaluate the symptoms at the vaccination site (local reactions) and systemic symptoms (systemic events) and will record with the health observation diary. Percentage of participants with specified AEs (systemic events) at the vaccination site will be reported.

Time frame: 56 days

Secondary Outcomes

Number of Participants who Take COVID-19 Pathogen (SARS-COV-2) Test during the Study

Time frame: 56 days

Number of Participants who Developed COVID-19 during the Study

Time frame: 56 days

Data from ClinicalTrials.gov

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