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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05894590

Enrollment

13680

Registered

2023-06-08

Start date

2022-11-15

Completion date

2023-12-20

Last updated

2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2

Keywords

mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna

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.

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Number of Participants With Serious Events Associated With all-Cause Hospitalizations	Up to 1 year post vaccination

Countries

Japan

Outcome results