Trial to Compare the Safety,Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children
This study has been completed.
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
First received: September 12, 2005
Last updated: October 2, 2006
Last verified: October 2006
- Trial to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture confirmed influenza illness in children.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized, Open-Label, Controlled Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, Trivalent, Type A&B, Live, Cold-Adapted (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children With a History of Recurrent Respiratory Tract Infections Aged 6 Months to Less Than 72 Months|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by MedImmune LLC:
Primary Outcome Measures:
- To demostrate that the efficacy over one season against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine
Secondary Outcome Measures:
- To demostrate that the efficacy over one season of CAIV-T is not inferior to that of TIV against culture-confirmed influenza-illness of any subtype
- To demonstrate that the efficacy of CAIV-T is not inferior to that of TIV against clinically-defined acute otitis media
- To compare the rate of occurence over a defined surveillance period in children with a histroy of recurrent RTIs
|Study Start Date:||October 2002|
|Estimated Study Completion Date:||June 2003|
- The purpose of this study is to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture confirmed influenza illness in children with a history of recurrent RTIs aged at least 6 months and less than 72 months of age.
- The trial also provides the opportunity to compare the efficacy of CAIV-T with TIV on acute otitis media.
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