A Randomized, Double-Blind Trial of the Safety, Transmissibility, and Phenotypic and Genotypic Stability of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T), in Children Who Attend Day Care. (Final Report Version 2.0)
Sponsor study identifier
interventional
200
1 country
1
Study Start
November 1999
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedTo assess whether CAIV-T was transmitted from vaccinated children to their unvaccinated contacts in a day care setting; and if so, to estimate the rate of transmission.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1999
Date type not reportedThis date has not been verified as actual or estimated.
September 12, 2005
Actual (reported)September 19, 2005
Actual (reported)The primary endpoint of the study was the determination of the proportion of placebo recipients from whom any of the vaccine strains were isolated.
The endpoint for children who received CAIV-T was the first nasal swab scored positive for viral shedding in
which the vaccine virus phenotype (cold-adapted and temperature sensitive) or genotype (6:2 reassortant) was
not preserved. Genotypic and phenotypic stability were summarized as the proportion of all vaccine viruspositive
isolates which retained the cold-adapted phenotype, temperature-sensitive phenotype or the 6:2
reassortant genotype of the vaccine strains.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kauppakatu Clinic
Tampere, 33101, Finland
Robert Walker, MD
MedImmune LLC
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
November 1999
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
October 25, 2006
Record last verified: 2006-10
Contact the study team to confirm eligibility.
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Source: ClinicalTrials.gov.
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