VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Subjects With Underlying Disease at High-risk for Worsening COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-11

Study Completion Date

2022-09-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance plan.

The present study aims to collect information on adverse drug reactions or COVID-19 infection after VAXZEVRIA vaccination and to evaluate the safety of this vaccine.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Long-term Safety of VAXZEVRIA

NCT05135455

Prevention of Infectious Disease Caused by SARS-CoV-2

COMPLETED

Survey of the Moderna COVID-19 Vaccine in People at High-Risk of Developing Severe COVID-19 Symptoms

NCT04892888

Coronavirus Disease (COVID-19)

WITHDRAWN

Long-Term Follow-up Survey of COVID-19 Vaccine After Vaccination

NCT04941144

Coronavirus Disease (COVID-19)

COMPLETED

A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers

NCT01375933

Smoking

COMPLETED PHASE3

A Study to Evaluate Safety and Immunogenicity of the ExPEC4V Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Participants Aged 18 Years and Older

NCT03500679

Healthy

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance plan.

The present study aims to collect information on adverse drug reactions (local/systemic reactions), adverse events (including Shock/ Anaphylaxis, Thrombosis in combination with thrombocytopenia, Immune-mediated neurological conditions ,Vaccine-associated enhanced disease(VAED) including Vaccine-associated enhanced respiratory disease(VAERD) and Thrombosis) or COVID-19 infection after VAXZEVRIA vaccination and to evaluate the safety of this vaccine

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prevention of Infectious Disease Caused by SARS-CoV-2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. The subjects with underlying disease at high-risk for worsening COVID-19.
2. The adults (in the case of a minor aged less than 20 years, the parent or the legal guardian) who are able to enter their symptoms in the health observation diary and who have been fully informed and have given written consent to the use of the needed information to be part of the observational study.