Trial to Evaluate the Immune Response to OPV When Administered Concomitantly With CAIV-T to Healthy Children.
This study has been completed.
Wyeth is now a wholly owned subsidiary of Pfizer
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First received: September 13, 2005
Last updated: October 2, 2006
Last verified: October 2006
Phase III trial to evaluate the immune response to oral poliovirus vaccine (OPV) when administered concomitantly with CAIV-T to healthy children.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Prevention
|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|
Resource links provided by NLM:
Further study details as provided by MedImmune LLC:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
|Study Start Date:||September 2001|
|Estimated Study Completion Date:||December 2001|
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