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

AstraZeneca

Status: Terminated

Conditions: Prevention of Infectious Disease Caused by SARS-CoV-2

Study type: Observational

Funder types: Industry

Identifiers

NCT05084755

D8111C00006

Details and patient eligibility

About

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.

Full description

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

Enrollment: 4 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

None