Drug Use Investigation for Arepanrix® (H1N1)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Influenza

Treatments: Biological: Arepanrix®

Study type: Observational

Funder types: Industry

Identifiers

NCT02069496

114128

Details and patient eligibility

About

This post-marketing surveillance study is designed to collect safety information such as post-vaccination adverse events and adverse reactions from recipients of Arepanrix® (H1N1) Intramuscular Injection.

The following items will be investigated as priority investigation items. <Priority investigation items>

1. Allergic reactions
2. Anaphylaxis

Enrollment: 3,405 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who receive Arepanrix® intramuscular injection for the first time

Exclusion criteria

• Not applicable

Trial design

3,405 participants in 1 patient group

Subjects who receive Arepanrix®

Description:

Subjects who receive Arepanrix® as per routine practice

Treatment:

Biological: Arepanrix®