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Post-Marketing Safety Study in Japan in Participants With High Risk of Severe Exacerbation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine

Sponsor
ModernaTX, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05894525
Collaborator
(none)
8,844
Enrollment
1
Location
6.2
Anticipated Duration (Months)
1416.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Data collected from the JDMC Claims Database between August 2020 to November 2021.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    8844 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Cohort Survey on Acute Phase Safety in Persons With Underlying Diseases Considered to Be at High Risk of Severe COVID-19 by Using Vaccination Information
    Actual Study Start Date :
    Dec 22, 2022
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort 1

    Participants received 2 doses of mRNA-1273 vaccine approximately 4 weeks apart.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Solicited Acute Adverse Events [Up to 8 days post vaccination]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 have underlying diseases. Data period for confirmation of presence/absence of underlying disease is August 2020 to November

    Exclusion Criteria:

    • Underlying diseases that were determined undetectable by the pre-screening of JMDC

    • Participants who did not consent to the questionnaire

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CMIC Co. Ltd., Tokyo Japan

    Sponsors and Collaborators

    • ModernaTX, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ModernaTX, Inc.
    ClinicalTrials.gov Identifier:
    NCT05894525
    Other Study ID Numbers:
    • mRNA-1273-P916
    First Posted:
    Jun 8, 2023
    Last Update Posted:
    Jun 8, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ModernaTX, Inc.
    mRNA-1273
    mRNA-1273 vaccine
    SARS-CoV-2
    SARS-CoV-2 Vaccine
    Coronavirus
    Virus Diseases
    Messenger RNA
    COVID-19
    COVID-19 Vaccine
    Moderna
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jun 8, 2023