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)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00192361|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : October 25, 2006
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: CAIV-T||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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)|
|Study Start Date :||November 1999|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192361
|Tampere, Finland, 33101|
|Study Director:||Robert Walker, MD||MedImmune LLC|