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

Cohort Survey on Shock and Anaphylaxis 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

NCT05894499

Enrollment

13309

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 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.

Detailed description

Data collected from the JDMC Claims Database between May 2021 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 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.

Design outcomes

Primary

Measure	Time frame
Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Either Dose 1 and Dose 2	Up to 2 days post vaccination after either the first or second vaccination

Secondary

Measure	Time frame
Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 1	Up to 2 days post vaccination
Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 2	Up to 2 days post vaccination

Countries

Japan

Outcome results