* 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
890
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 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
Heart of America Research Institute
Shawnee Mission, Kansas, United States
Kentucky Pediatric/Adult Research, Inc.
Bardstown, Kentucky, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States
- 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.