Drug Use Investigation for Arepanrix® (H1N1)

Completed

• Conditions: Influenza
• Interventions: Biological: Arepanrix®

• Registration Number: NCT02069496
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-07
• Study Completion: 2010-10
• Status Verified: 2012-08
• Study First Submitted: 2014-02-20
• Study First Submitted QC: 2014-02-20
• Last Update Submitted: 2014-02-20
• Study First Posted: 2014-02-24
• Last Update Posted: 2014-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3405

Inclusion Criteria

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

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects who receive Arepanrix®	Arepanrix®	Subjects who receive Arepanrix® as per routine practice

Primary Outcome Measures

Name	Time	Method
The number of recipients who have adverse reactions after injection	29 days
The number of recipients who have post-vaccination adverse events after injection	29 days
The number of recipients who have allergic reactions after injection	29 days
The number of recipients who have anaphylaxis after injection	29 days