Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)

Completed

• Conditions: Influenza, Human
• Interventions: Drug: Zanamivir hydrate

• Registration Number: NCT01390792
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this post-marketing surveillance study is to collect information on efficacy and safety for prophylactic administration of zanamivir in clinical practice in family or persons living with patients with influenza virus infection.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2009-02
• Study Completion: 2009-05
• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 622

Inclusion Criteria

• Subjects who meet the study population criteria

Exclusion Criteria

• Subjects with a history of hypersensitivity to the ingredients of zanamivir

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects prescribed zanamivir	Zanamivir hydrate	Subjects prescribed zanamivir during study period

Primary Outcome Measures

Name	Time	Method
The number of incidence of adverse events in subjects treated with zanamivir	11 days
Occurrence of influenza virus infection	11 days