VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Subjects With Underlying Disease at High-risk for Worsening COVID-19
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- STATUS
- Recruiting
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- End date
- Oct 31, 2022
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- participants needed
- 1000
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- sponsor
- AstraZeneca
Summary
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.
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.
Details
| Condition | Prevention of Infectious Disease Caused by SARS-CoV-2 |
|---|---|
| Clinical Study Identifier | NCT05084755 |
| Sponsor | AstraZeneca |
| Last Modified on | 3 June 2022 |
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