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

Sponsor

ModernaTX, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05894590

Collaborator

(none)

8,000

Enrollment

Location

Anticipated Duration (Months)

1995.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

8000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official 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

Anticipated Study Start Date :

Aug 31, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 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

Number of Participants With Serious Events Associated With all-Cause Hospitalizations [Up to 1 year post vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.