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

Cohort Survey on Acute Phase Safety in Persons With Underlying Diseases 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

NCT05894525

Enrollment

8844

Registered

2023-06-08

Start date

2022-11-15

Completion date

2023-05-26

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 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.

Detailed description

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

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 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

Design outcomes

Primary

Measure	Time frame
Number of Participants With Solicited Acute Adverse Events	Up to 8 days post vaccination

Countries

Japan

Outcome results