A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial To Assess Safety And Efficacy Of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) In Adults Aged 60 Years And Older CAIV-T, Liquid Formulation
Sponsor study identifier
interventional
3,000
1 country
1
Study Start
April 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
November 2001
Date type not reportedThis date has not been verified as actual or estimated.
The purpose of this study is to determine the efficacy, safety and tolerability of the liquid formulation of CAIV-T against culture confirmed influenza illness in adults aged 60 years and older. In addition this study aims to demonstrate superiority of CAIV-T when compared with placebo and the effect on economic resources.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2001
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2001
Date type not reportedThis date has not been verified as actual or estimated.
November 2001
Date type not reportedThis date has not been verified as actual or estimated.
September 12, 2005
Actual (reported)September 22, 2005
Actual (reported)The primary study endpoint was the comparison of efficacy of CAIV-T versus placebo against culture-confirmed influenza-illness caused by community-acquired influenza subtypes that were antigenically similar to those contained in the vaccine.
A secondary comparison of interest was the incidence of culture-confirmed influenza-illness caused by any antigenic subtype.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Family & Primary Care, Faculty of Medicine, University of Stellenbosch
Tygerberg, 7505, South Africa
De Villiers PJ, Steele AD, Hiemstra LA, Rappaport R, Dunning AJ, Gruber WC, Forrest BD; LAIV Elderly Study Trial Network. Efficacy and safety of a live attenuated influenza vaccine in adults 60 years of age and older. Vaccine. 2009 Dec 10;28(1):228-34. doi: 10.1016/j.vaccine.2009.09.092. Epub 2009 Sep 29.
Pjt de Villiers, Professor
Dept of Family Medicine & Primary Care, University of Stellenbosch
First Submitted
September 12, 2005
First Posted
September 22, 2005
Study Start
April 2001
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
November 2001
Date type not reportedContact the study team to confirm eligibility.
This date has not been verified as actual or estimated.
Last Updated
October 3, 2006
Record last verified: 2006-10
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Source: ClinicalTrials.gov.
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