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

Moderna

Status: Completed

Conditions: SARS-CoV-2

Study type: Observational

Funder types: Industry

Identifiers

NCT05894499

mRNA-1273-P915

Details and patient eligibility

About

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.

Full description

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

Enrollment: 13,309 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Exclusion criteria

• Underlying diseases that were determined undetectable by the pre-screening of JMDC
• Participants who did not consent to the questionnaire.

Trial design

13,309 participants in 1 patient group

Cohort 1

Description:

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