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

Sponsor

ModernaTX, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05894499

Collaborator

(none)

13,309

Enrollment

Location

6.2

Anticipated Duration (Months)

2132.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

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

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

13309 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official 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

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

Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Either Dose 1 and Dose 2 [Up to 2 days post vaccination after either the first or second vaccination]

Secondary Outcome Measures

Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 1 [Up to 2 days post vaccination]
Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 2 [Up to 2 days 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. Data period for confirmation of presence/absence of underlying disease is May 2021 to November 2021.