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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13680 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-15

Study Completion Date

2023-12-20

Brief Summary

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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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Detailed Description

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

Conditions

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SARS-CoV-2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1

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

No interventions assigned to this group

Eligibility Criteria

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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.