NCT05687877

Evusheld Japan PMS_Japan Post-Marketing Surveillance (PMS)

General Drug Use-Result Study of Evusheld Intramuscular Injection Set (Treatment and Prevention of Symptomatic Disease Caused by SARS-CoV-2 Infection)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 366 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese.

Detailed description

To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese. The investigation will be conducted as the addtional pharmacovigilance activitiy specified in the Japan Risk Management Plan (J-RMP) of Evusheld in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for re-examination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act).

Conditions

• SARS-CoV-2 Infection

Timeline

• Start date: 2023-01-06
• Primary completion: 2025-01-20
• Completion: 2025-01-20
• First posted: 2023-01-18
• Last updated: 2026-01-08

Locations

18 sites across 1 country: Japan