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

Moderna

Status: Completed

Conditions: SARS-CoV-2

Study type: Observational

Funder types: Industry

Identifiers

NCT05894590

mRNA-1273-P917

Details and patient eligibility

About

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.

Full description

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

Enrollment: 13,680 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.

Exclusion criteria

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

Trial design

13,680 participants in 1 patient group

Cohort 1

Description:

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