Trial of the Safety, Transmissibility, and Phenotypic and Genotypic Stability of Influenza Virus Vaccine,(CAIV-T), in Children Who Attend Day Care. (Final Report Version 2.0)
This study has been completed.
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First received: September 12, 2005
Last updated: October 23, 2006
Last verified: October 2006
To 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||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)|
Resource links provided by NLM:
Further study details as provided by MedImmune LLC:
Primary Outcome Measures:
- The primary endpoint of the study was the determination of the proportion of placebo recipients from whom any of the vaccine strains were isolated.
Secondary Outcome Measures:
- 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.
|Study Start Date:||November 1999|
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