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NCT01390792 Clinical Trial

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

Influenza, Human Clinical Trial

Official title:
Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01390792
Other study ID # 112316
Secondary ID
Status Completed
Phase N/A
First received July 7, 2011
Last updated May 15, 2017
Start date January 2007
Est. completion date May 2009

Study information
Verified date May 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 622
Est. completion date May 2009
Est. primary completion date February 2009
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Subjects who meet the study population criteria

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Zanamivir hydrate

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

References & 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.

Outcome
Type Measure Description Time frame Safety issue
Primary The number of incidence of adverse events in subjects treated with zanamivir 11 days
Primary Occurrence of influenza virus infection 11 days
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