Post-Marketing Non-Acute Safety Study in Japan After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in Persons at High Risk of Severe COVID-19

The goal of this study is to assess serious adverse events associated with hospitalizations in the non-acute phase after vaccination with the mRNA-1273 vaccine in persons with underlying diseases who are considered to have a high risk of severe exacerbation of COVID-19.

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Key information

Conditions

SARS-CoV-2 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CMIC Co., Ltd

Tokyo, Japan

About this study

Data collected from the JMDC Claims database from May 2020 to October 2022.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants registered to receive the mRNA-1273 vaccine in the Pep Up vaccination history Database
Participants who have a history of vaccination with the mRNA-1273 vaccine in the Pep-Up vaccination history Database and the observation start date is at least 6 months prior to vaccination with the mRNA-1273 vaccine and have underlying diseases.

Exclusion criteria

Underlying diseases that were determined undetectable by the pre-screening of JMDC
Participants who did not consent to the questionnaire.

Treatment and study plan

Primary outcomes

Number of Participants With Serious Events Associated With all-Cause Hospitalizations

Time frame: Up to 1 year post vaccination

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

Cohort Survey on Non-Acute Safety in Persons With Underlying Diseases Who Are Considered to Be at High Risk of Severe COVID-19 by Using Vaccination Information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jun 8, 2023
Registry last updated: Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed