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

May 15, 2017 updated by: GlaxoSmithKline
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

622

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

<Zanamivir prophylactic administration group> Subjects meeting all of the following criteria and starting prophylactic administration of zanamivir

  • family or persons living with patients with influenza virus infection
  • subjects meeting any of the following criteria, elderly subjects ( 65 years old and over), subjects with chronic cardiac disease, with metabolic disease (diabetes, etc.) or with renal dysfunction
  • unvaccinated persons during the applicable seasons
  • subjects whose consent to write influenza diary was obtained

<Non-zanamivir prophylactic administration group>

- subjects meeting all of the above criteria and NOT starting prophylactic administration of zanamivir

Description

Inclusion Criteria:

  • Subjects who meet the study population criteria

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects prescribed zanamivir
Subjects prescribed zanamivir during study period
Drug: Zanamivir hydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of incidence of adverse events in subjects treated with zanamivir
Time Frame: 11 days
11 days
Occurrence of influenza virus infection
Time Frame: 11 days
11 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Keizo Matsumoto, Hideyuki Okano, Naomi Hasegawa, Ichiro Ohwaki, Shogo Inoshiri. Study on Preventive Effects of Zanamivir (Relenza) for Influenza. Medicine and Drug Journal. 2010;46(11):121-132.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

July 7, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 11, 2011

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112316

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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