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Zanamivir Versus Trivalent Split Virus Influenza Vaccine

NCT00784784 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2014-11-21

Study results available
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Summary

This unblinded pilot study is intended to assess the feasibility of a larger double-blind, randomized control trial. For the larger trial the investigators are interested in understanding the relative benefits of vaccine and antiviral prophylaxis, the risk factors for influenza infection in healthy adults, and in assessing the safety and tolerability of seasonal antiviral prophylaxis in healthcare workers.

The pilot study will be assessing the rate of infection with influenza and the rate of adherence to long-term zanamivir in 60 healthy volunteers.

Conditions

Interventions

BIOLOGICAL

Fluviral

One dose

DRUG

Zanamivir

10 mg, OD, for duration of influenza season (10-23 weeks)

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Allison McGeer, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-05-31
Completion
2009-06-30

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00784784 on ClinicalTrials.gov