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

Moderna

Status: Completed

Conditions: SARS-CoV-2

Study type: Observational

Funder types: Industry

Identifiers

NCT05894525

mRNA-1273-P916

Details and patient eligibility

About

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.

Full description

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

Enrollment: 8,844 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 have underlying diseases. Data period for confirmation of presence/absence of underlying disease is August 2020 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

8,844 participants in 1 patient group

Cohort 1

Description:

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