Trial to Evaluate the Immune Response to OPV When Administered Concomitantly With CAIV-T to Healthy Children.
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|ClinicalTrials.gov Identifier: NCT00192426|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : October 3, 2006
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: CAIV-T||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2400 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Prospective, Randomized, Partially-Blinded, Placebo-Controlled, Phase III, Multicenter Trial to Assess Safety, Tolerability and Immunogenicity of Liquid CAIV-T Administered Concomitantly With OPV in Healthy Children|
|Study Start Date :||September 2001|
|Estimated Study Completion Date :||December 2001|
- The primary immunogenicity endpoint is the proportion of subjects achieving a post-vaccination serum antibody response for each antigen component of OPV and CAIV-T.
- The secondary endpoint for immunogenicity is the geometric mean titer (GMT) of serum antibody for each antigen component of OPV or the geometric mean ratio relative to the baseline titer of CAIV-T serum antibody components.
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): NCT00192426
|Study Director:||Robert Walker, MD||MedImmune LLC|