Trial to Demonstrate Equivalent Immunogenicity of CAIV-T and FLUMIST in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT00192335|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : November 27, 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
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: CAIV-T Biological: CAIVT Biological: FluMist||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||890 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||July 2004|
|Actual 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).
- - 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 ]
- The proportion of participants experiencing each of the reactogenicity events by dose. [ Time Frame: Within 28 days of vaccination ]
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): 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|
|Principal Investigator:||Luis Angles, MD||Heart of America Research Institute|