Clinical Trials Directory

Trials / Completed

CompletedNCT00192335

Trial to Demonstrate Equivalent Immunogenicity of CAIV-T and FLUMIST in Healthy Participants

A Prospective, Double-Blind, Randomized Trial to Demonstrate Equivalent Immunogenicity of CAIV-T and FLUMIST in Healthy Participants Ages 5 Through 49 Years

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
890 (actual)
Sponsor
MedImmune LLC · Industry
Sex
All
Age
5 Years – 49 Years
Healthy volunteers
Accepted

Summary

* 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

Conditions

Interventions

TypeNameDescription
BIOLOGICALCAIV-T
BIOLOGICALCAIVTThe total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
BIOLOGICALFluMistThe total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).

Timeline

Start date
2004-07-01
Completion
2005-02-01
First posted
2005-09-19
Last updated
2007-11-27

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00192335. Inclusion in this directory is not an endorsement.