Trial to Demonstrate Equivalent Immunogenicity of CAIV-T and FLUMIST in Healthy Participants
This study has been completed.
Information provided by:
First received: September 12, 2005
Last updated: November 26, 2007
Last verified: November 2007
- Primary objective is to demonstrate equivalent immunogeniticity of CAIV-T and FluMist
- Secondary objective of this study is to assess the safety and tolerability of CAIV-T compared to FluMist
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Prospective, Double-Blind, Randomized Trial to Demonstrate Equivalent Immunogenicity of CAIV-T and FLUMIST in Healthy Participants Ages 5 Through 49 Years|
Resource links provided by NLM:
Further study details as provided by MedImmune LLC:
Primary Outcome Measures:
- - Among participants 5 through 8 years of age regardless of baseline serostatus who receive two doses, the post-dose two strain-specific geometric mean titers (GMTs) for serum HAI in the CAIV-T group are within 2-fold of those in the FluMist group [ Time Frame: greater than 28-days post dose ]
Secondary Outcome Measures:
- The proportion of participants experiencing each of the reactogenicity events by dose. [ Time Frame: Within 28 days of vaccination ]
|Study Start Date:||July 2004|
|Study Completion Date:||February 2005|
Active Comparator: 1
CAIVT-The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
Active Comparator: 2
FluMist- The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192335
|United States, Kansas|
|Heart of America Research Institute|
|Shawnee Mission, Kansas, United States, 66216|
|United States, Kentucky|
|Kentucky Pediatric/Adult Research, Inc.|
|Bardstown, Kentucky, United States, 40004|
|United States, Texas|
|R/D Clinical Research, Inc.|
|Lake Jackson, Texas, United States, 77566|
Sponsors and Collaborators
|Principal Investigator:||Luis Angles, MD||Heart of America Research Institute|