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OpenTrials
Completed

NCT Number: NCT05894499

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

The goal of this study is to confirm the onset status of hypersensitivity reactions including shock and anaphylaxis observed after vaccination with this drug in persons with underlying diseases who are considered to have a high risk of severe exacerbation of COVID-19 and explore risk factors.

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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 JDMC Claims Database between May 2021 to November 2021.

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. Data period for confirmation of presence/absence of underlying disease is May 2021 to November 2021.

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

  1. Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Either Dose 1 and Dose 2

    Time frame: Up to 2 days post vaccination after either the first or second vaccination

Secondary outcomes

  1. Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 1

    Time frame: Up to 2 days post vaccination

  2. Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 2

    Time frame: Up to 2 days post vaccination

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

Cohort Survey on Shock and Anaphylaxis in Persons With Underlying Diseases 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.

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