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| Name | Class |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
Phase III trial to evaluate the immune response to oral poliovirus vaccine (OPV) when administered concomitantly with CAIV-T to healthy children.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAIV-T | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
If any of these criteria are met following enrollment, the subject will be excluded from subsequent vaccine dosing.
Note: Pregnancy in a household member or any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Walker, MD | MedImmune LLC | Study Director |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000613429 | FluMist |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |