NCT01390792

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
622

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

2.1 years

First QC Date

July 7, 2011

Last Update Submit

May 15, 2017

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (2)

  • The number of incidence of adverse events in subjects treated with zanamivir

    11 days

  • Occurrence of influenza virus infection

    11 days

Study Arms (1)

Subjects prescribed zanamivir

Subjects prescribed zanamivir during study period

Drug: Zanamivir hydrate

Interventions

Zanamivir hydrateDRUG
Subjects prescribed zanamivir

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Subjects who meet the study population criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 11, 2011

Study Start

January 1, 2007

Primary Completion

February 1, 2009

Study Completion

May 1, 2009

Last Updated

May 16, 2017

Record last verified: 2017-05